Deintensification of potentially inappropriate medications amongst older frail people with type 2 diabetes: Protocol for a cluster randomised controlled trial (D-MED study).

AIMS: Amongst elderly people with type 2 diabetes (T2D) over prescribing can result in emergency ambulance call-outs, falls and fractures and increased mortality, particularly in frail patients. Current clinical guidelines, however, remain focused on medication intensification rather than deintensification where appropriate. This study aims to evaluate the effectiveness of an electronic decision-support system and training for the deintensification of potentially inappropriate medications amongst older frail people with T2D, when compared to 'usual' care at 12-months. METHODS: This study is an open-label, multi-site, two-armed pragmatic cluster-randomised trial. GP practices randomised to the 'enhanced care' group have an electronic decision support system installed and receive training on the tool and de-intensification of diabetes medications. The system flags eligible patients for possible deintensification of diabetes medications, linking the health care professional to a clinical algorithm. The primary outcome will be the number of patients at 12-months who have had potentially inappropriate diabetes medications de-intensified. RESULTS: Study recruitment commenced in June 2022. Data collection commenced in January 2023. Baseline data have been extracted from 40 practices (3145 patients). CONCLUSIONS: Digital technology, involving computer decision systems, may have the potential to reduce inappropriate medications and aid the process of de-intensification. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN53221378. Available at: https://www.isrctn.com/ISRCTN53221378.

Implementation of a diabetes prevention programme in a multi-ethnic community in primary care in England: An evaluation using constructs from the RE-AIM Framework.

AIMS: To implement a diabetes prevention programme in primary care METHODS: The programme was implemented for 12 months in two neighbouring towns, served by eight general practices. Practices requested a referral pathway involving an external administrator running electronic searches and sending postal invitations. If interested, people called and booked a place on the programme. Practices were also provided with resources to refer people directly. Six Educators were trained to deliver the programme. The RE-AIM constructs "Adoption", "Reach" and "Uptake" were assessed. RESULTS: All practices engaged in the searches and postal invitations. Overall, 3.9 % of those aged ≥ 25 years had an HbA1c level indicative of non-diabetic hyperglycaemia (NDH) and were invited. Overall uptake (attended as percentage of invited) was 16 % (practice range 10.5-26.6 %) and was highest in two practices where the invitation was followed by a telephone call. Four people were referred directly by their practice. Groups at risk of being excluded were the Bengali population and those unable to attend because of issues such as health, mobility and frailty. CONCLUSIONS: Comprehensive electronic searches meant everyone previously diagnosed with NDH was invited to attend. Follow-up telephone call improved uptake and providing practices with resources to make these calls themselves would likely increase uptake further.

Structured group education programme and accompanying mHealth intervention to promote physical activity in women with a history of gestational diabetes: A randomised controlled trial.

AIMS: Assess effectiveness of a hybrid intervention targeting physical activity in women with prior gestational diabetes. METHODS: Randomised controlled trial with parallel arms. 293 women (35.1 ± 5.1 years; 40% ethnic minority) recruited from two hospitals and randomised to routine care or hybrid lifestyle intervention comprising two group sessions and access to a mobile web app. Primary outcome was a change in objectively measured physical activity at 12 months. Secondary outcomes included self-efficacy for exercise, quality of life and anxiety and depression. Linear regression compared outcome measures between groups. RESULTS: 83% of intervention participants attended at least one group session, of who 66% registered to use the app. There was a non-significant increase in physical activity at 12 months (between-group difference of 0.95 mg [95% CI: -0.46 to 2.37]), equivalent to approximately 500 steps per day. Intervention participants reported higher self-efficacy for exercise (0.54, 95% CI: 0.05 to 1.102; p = 0.029), lower anxiety (-0.91, 95% CI: -1.74 to -0.09; p = 0.031), and higher quality of life (0.05, 95% CI: 0.004 to 0.09; p = 0.032), compared to controls. CONCLUSIONS: The intervention improved confidence in exercise and quality of life. Further research is needed to improve participant engagement with physical activity interventions in multi-ethnic populations with a history of gestational diabetes.

The effectiveness of a structured group education programme for people with established type 2 diabetes in a multi-ethnic population in primary care: A cluster randomised trial.

BACKGROUND AND AIMS: Structured self-management education has been shown to be effective in type 2 diabetes (T2DM) but more research is needed to look at culturally appropriate programmes in ethnic minority groups, where prevalence of T2DM is higher and diagnosis earlier. The study tested the effectiveness of a group education programme for people with established T2DM in a multi-ethnic primary care population. METHODS AND RESULTS: Cluster randomised trial conducted in two multi-ethnic UK sites. Practices were randomised (1:1) to a structured T2DM group education programme or to continue with routine care. A culturally-adapted version was offered to South Asians, who formed the majority of ethnic minority participants. Other ethnic minority groups were invited to attend the standard programme. Primary outcome was change in HbA1c at 12 months. All analyses accounted for clustering and baseline value.367 participants (64(SD 10.8) years, 36% women, 34% from minority ethnic groups) were recruited from 31 clusters. At 12 months, there was no difference in mean change in HbA1c between the two groups (-0.10%; (95% CI: -0.37, 0.17). Subgroup analyses suggested the intervention was effective at lowering HbA1c in White European compared with ethnic minority groups. The intervention group lost more body weight than the control group (-0.82 kg at 6 months and -1.06 kg at 12 months; both p = 0.03). CONCLUSION: Overall, the programme did not result in HbA1c improvement but in subgroup analysis, a beneficial effect occurred in White Europeans. Findings emphasise a need to develop and evaluate culturally-relevant programmes for ethnic minority groups.

Randomised controlled trial of an innovative hypoglycaemia pathway for self-care at home and admission avoidance: a partnership approach with a regional ambulance trust.

Background: Hypoglycaemia is a common and potentially life-threatening condition in people with diabetes, commonly caused by medications such as insulin. Hypoglycaemic events often require in-patient treatment and/or follow-up with a diabetes specialist nurse (DSN) or GP to make adjustments to medication. This referral pathway commonly relies on patient self-referral to primary care, and as a result many patients are not actively followed up and go on to experience repeat hypoglycaemic events. Methods: Randomised controlled trial in partnership with East Midlands Ambulance Service NHS Trust. People with diabetes calling out an ambulance for a severe hypoglycaemic episode and meeting the eligibility criteria were randomised to either a novel DSN-led pathway or to their general practice for routine follow-up. Primary outcome was proportion of participants with a documented consultation with a healthcare professional to discuss the management of their diabetes within 28 days of call-out. Results: 162 people were randomised to one of the pathways (73 DSN arm, 89 GP arm) with 81 (50%, 35 DSN, 46 GP) providing full consent to be followed up. Due to lower than anticipated randomisation and consent rates, the recruitment target was not met. In the 81 participants who provided full consent, there were higher rates of consultation following the call-out when referred to a DSN compared to primary care (90% vs. 65%). Of the 81 participants, 26 (32%) had a second call-out within 12 months. Conclusions: Consultation rates following the call-out were high in the DSN-led arm, but there was insufficient power to complete the planned comparative analysis. The study highlighted the difficulty in recruitment and delivery of research in pre-hospital emergency care. Further work is needed to provide more feasible study designs and consent procedures balancing demands on ambulance staff time with the need for robust well-designed evaluation of referral pathways.

Promoting physical activity with self-management support for those with multimorbidity: a randomised controlled trial.

BACKGROUND: Targeted self-management programmes may improve health and increase physical activity (PA) in people with multimorbidity. AIM: To investigate the impact of a structured, theoretically driven, self-management group education programme on habitual PA levels in people with multimorbidity. DESIGN AND SETTING: Individually randomised controlled trial with 12-month follow-up, involving nine primary care practices in Leicestershire, UK. METHOD: In total, 353 adults with multimorbidity (age 67.8 years [±9 years], 161 male sex) were randomised to intervention (n = 180) or control (n = 173) groups. Intervention participants were invited to attend four group-based self-management sessions, centred primarily on increasing PA, and received motivational text-message support. The primary outcome measure was change in overall volume (time and intensity) of daily PA at 12 months, as measured by the GENEActiv wrist-worn accelerometer device. RESULTS: At baseline, the total sample achieved 22 min of moderate-vigorous intensity PA per day (mean/participant). At 12 months, in the complete-case analysis, a reduction in daily mean PA volume was seen in the intervention group relative to control (-0.80 milligravity [m g]; 95% confidence interval [CI] = -1.57 to -0.03; P = 0.04). Reductions were also seen in the intervention group in time spent in moderate-vigorous PA (-3.86 min per day; 95% CI= -6.70 to -1.03; P = 0.008) and time spent at an intensity equivalent to a slow walk (-4.66 min per day; 95% CI = -8.82 to -0.51; P = 0.028). However, the per-protocol analysis (excluding participants who did not attend at least one education session) found no between-group differences in overall daily PA at 12 months (-0.65 mg; 95% CI = -1.46 to 0.15; P = 0.11). CONCLUSION: The self-management programme elicited a slight reduction in PA levels in people with multimorbidity. Future research should identify and target subgroups of those with multimorbidity in greatest need of PA promotion in order to maximise potential capacity for benefit, and also focus on refining the intervention in order to increase efficacy in increasing PA.

Experiences of using a digital type 2 diabetes prevention application designed to support women with previous gestational diabetes.

BACKGROUND: Gestational diabetes mellitus (GDM) is diagnosed during pregnancy, and women with a history of GDM are at a higher risk of developing type 2 diabetes mellitus (T2DM). Prevention strategies focused on lifestyle modification help to reduce long-term complications. Self-management technology-based interventions can support behaviour change and diabetes control. The Baby Steps programme, a randomised controlled trial intervention offering group education and access to a mobile web application, was evaluated to explore user experience of the app and barriers and facilitators to app usability. METHODS: Ten semi-structured interviews and four focus group discussions were conducted with 23 trial participants between 2018 and 2019. Interviews and focus group discussions were audiotaped, transcribed and independently analysed. The analysis was informed by thematic analysis, with the use of the Nvivo 12 software. RESULTS: Themes identified were: (1) GDM and post-pregnancy support from healthcare services; (2) Impact of Baby Steps app on lifestyle changes; (3) Facilitators and barriers to the usability of the Baby Steps app. The Baby Steps app served as a motivator for increasing self-management activities and a tool for monitoring progress. Peer support and increased awareness of GDM and T2DM enhanced engagement with the app, while poor awareness of all the components of the app and low technical skills contributed to low usability. CONCLUSIONS: This study documents experiences from existing GDM support, user experiences from using the Baby Steps app, and the barriers and facilitators to app usability. The app was both a motivational and a monitoring tool for GDM self-management and T2DM prevention. Peer support was a key trait for enhanced engagement, while barriers were low technical skills and poor awareness of the app components. A digital app, such as the Baby Steps app, could strengthen existing face-to-face support for the prevention of T2DM. The results also have wider implications for digital support technologies for all self-management interventions. Further research on the effect of specific components of apps will be required to better understand the long term impact of apps and digital interventions on self-management behaviours and outcomes. TRIAL REGISTRATION: ISRCTN, ISRCTN17299860 . Registered on 5 April 2017.

Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial.

BACKGROUND: Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention. METHODS: Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013-2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables. RESULTS: One thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up. CONCLUSIONS: Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months. TRIAL REGISTRATION: ISRCTN 83465245 (registered on 14 June 2012).

Physical Activity after Cardiac EventS (PACES): a group education programme with subsequent text message support designed to increase physical activity in individuals with diagnosed coronary heart disease: a randomised controlled trial.

AIM: To assess the effectiveness of a low-cost pragmatic intervention (structured education and ongoing text message support) to increase daily physical activity in participants 12-48 months after a coronary heart disease cardiac event (myocardial infarction, angina or acute coronary syndrome) diagnosis. METHODS: A single-centre randomised controlled trial of 291 adults randomised to a structured education programme (n=145) or usual care (n=146). The programme consisted of two 2.5 hour sessions delivered 2 weeks apart, followed by supplementary text message support. The GENEActiv accelerometer assessed the primary outcome at 12 months (change in overall physical activity (expressed in milli gravitational (mg) units) from baseline). Secondary outcomes included anthropometric, physical function, cardiovascular, biochemical and patient-reported outcome measures. Linear regression was used to compare outcome measures between groups on a modified intention-to-treat basis. RESULTS: Participants' mean age was 66.5±9.7 years, 84.5% males, 82.5% white British and 15.5% south Asian. At 12 months, there was no difference between the groups in terms of change in overall physical activity (-0.23 mg (95% CI -1.22 to 0.75), p=0.64) and the programme was well accepted (88% attendance). Exploratory analyses showed that average moderate to vigorous physical activity (MVPA) levels increased in individuals not meeting physical activity guidelines (≥150 min per week) on enrolment compared with those who did, by 8 minutes per day (8.04 (95% CI 0.99 to 15.10), p=0.03). CONCLUSION: The programme was well attended but showed no change in physical activity levels. Results show high baseline MVPA levels and suggest that Physical Activity after Cardiac EventS education may benefit cardiac patients not currently meeting activity guidelines. TRIAL REGISTRATION NUMBER: ISRCTN91163727.

Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT.

BACKGROUND: Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. OBJECTIVES: To investigate whether or not Walking Away from Diabetes (Walking Away) - a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes - leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. DESIGN: Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. SETTING: Primary care and the community. PARTICIPANTS: Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. INTERVENTIONS: Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. MAIN OUTCOME MEASURES: The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. RESULTS: A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval -290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval -282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. LIMITATIONS: Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. CONCLUSIONS: Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. FUTURE WORK: Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83465245. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

When someone has type 2 diabetes, it means that their body no longer does a good job of controlling the sugar in their blood. This gives them a higher risk of other health problems. Fortunately, people can avoid getting type 2 diabetes if they can change their lifestyle. We wanted to know whether or not an education programme could help people at high risk of getting diabetes to become more physically active and, if so, whether or not they were still more active and healthier 4 years later. We also wanted to know whether it made a difference if we used text messages and telephone calls to support them and whether it worked better for some ethnic groups than others. We put 1366 people into one of three groups at random. The first group received an advice leaflet. The second group attended (in groups of up to 10 participants) a 3-hour education programme called 'Walking Away from Type 2 Diabetes' to help them to change their behaviour and then attended a group-based refresher session every year. The third group received the same education programme and the refresher sessions, but also received text messages and telephone calls to give them extra support. We measured how active the participants were at the start of the study, after 1 year and again 3 years after that (i.e. 4 years after the start). Then we looked at whether or not the Walking Away programme, with and without the extra support of text messages and telephone calls, did a better job of encouraging people to be more active than just giving them the advice leaflet. We found out that the Walking Away programme, when combined with text messages and telephone calls for support, did help participants to take over 500 more steps per day during the first year; however, when we checked again at 4 years, we found that the effects had worn off. Neither option proved to be good value for money.

Effectiveness of the Ready to Reduce Risk (3R) complex intervention for the primary prevention of cardiovascular disease: a pragmatic randomised controlled trial.

BACKGROUND: Cardiovascular disease is responsible for 31% of all global deaths. Primary prevention strategies are needed to improve longer-term adherence to statins and healthy lifestyle behaviours to reduce risk in people at risk of cardiovascular disease. METHODS: Pragmatic randomised controlled trial recruited between May 2016 and March 2017 from primary care practices, England. Participants (n = 212) prescribed statins for primary prevention of cardiovascular disease with total cholesterol level ≥ 5 mmol/l were randomised: 105 to the intervention group and 107 to the control group, stratified by age and sex. The 3R intervention involved two facilitated, structured group education sessions focusing on medication adherence to statins, lifestyle behaviours and cardiovascular risk, with 44 weeks of medication reminders and motivational text messages and two supportive, coaching phone calls (at approximately 2 weeks and 6 months). The control group continued with usual clinical care. Both groups received a basic information leaflet. The primary outcome was medication adherence to statins objectively measured by a biochemical urine test. Self-reported adherence and practice prescription data provided additional measures. Secondary outcomes included cholesterol profile, blood pressure, anthropometric data, cardiovascular risk score, and self-reported lifestyle behaviours and psychological measures (health/medication beliefs, quality of life, health status). All outcomes were assessed at 12 months. RESULTS: Baseline adherence to statins was 47% (control) and 62% (intervention). No significant difference between the groups found for medication adherence to statins using either the urine test (OR 1.02, 95% CI 0.34 to 3.06, P = 0.968) or other measures. This may have been due to the higher than expected adherence levels at baseline. The adjusted mean difference between the groups (in favour of the intervention group) for diastolic blood pressure (- 4.28 mmHg (95% CI - 0.98 to - 1.58, P = 0.002)) and waist circumference (- 2.55 cm (95% CI - 4.55 to - 0.55, P = 0.012)). The intervention group also showed greater perceived control of treatment and more coherent understanding of the condition. CONCLUSIONS: The 3R programme successfully led to longer-term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about the suitability of such a broad, multiple risk factor approach for improving medication adherence for primary prevention of CVD. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN16863160), March 11, 2006.

Effects of an Electronic Software "Prompt" With Health Care Professional Training on Cardiovascular and Renal Complications in a Multiethnic Population With Type 2 Diabetes and Microalbuminuria (the GP-Prompt Study): Results of a Pragmatic Cluster-Randomized Trial.

OBJECTIVE: Tight, targeted control of modifiable cardiovascular risk factors can reduce cardiovascular complications and mortality in individuals with type 2 diabetes mellitus (T2DM) and microalbuminuria. The effects of using an electronic "prompt" with a treatment algorithm to support a treat-to-target approach has not been tested in primary care. RESEARCH DESIGN AND METHODS: A multicenter, cluster-randomized trial was conducted among primary care practices across Leicestershire, U.K. The primary outcome was the proportion of individuals achieving systolic and diastolic blood pressure (<130 and <80 mmHg, respectively) and total cholesterol (<3.5 mmol/L) targets at 24 months. Secondary outcomes included proportion of individuals with HbA1c <58 mmol/mol (<7.5%), changes in prescribing, change in the albumin-to-creatinine ratio, major adverse cardiovascular events, cardiovascular mortality, and coding accuracy. RESULTS: A total of 2,721 individuals from 22 practices, mean age 63 years, 41% female, and 62% from black and minority ethnic groups completed 2 years of follow-up. There were no significant differences in the proportion of individuals achieving the composite primary outcome, although the proportion of individuals achieving the prespecified outcome of total cholesterol <4.0 mmol/L (odds ratio 1.24; 95% CI 1.05-1.47; P = 0.01) increased with intensive intervention compared with control. Coding for microalbuminuria increased relative to control (odds ratio 2.05; 95% CI 1.29-3.25; P < 0.01). CONCLUSIONS: Greater improvements in composite cardiovascular risk factor control with this intervention compared with standard care were not achieved in this cohort of high-risk individuals with T2DM. However, improvements in lipid profile and coding can benefit patients with diabetes to alter the high risk of atherosclerotic cardiovascular events. Future studies should consider comprehensive strategies, including patient education and health care professional engagement, in the management of T2DM.

Qualitative evaluation of A Safer Ramadan, a structured education programme that addresses the safer observance of Ramadan for Muslims with Type 2 diabetes.

AIMS: Muslims can choose to fast during Ramadan. Guidelines exist for providing clinical support for this group, but there is a lack of culturally tailored diabetes management interventions to provide guidance. The study evaluates the implementation of a programme developed to meet this need. METHODS: A Safer Ramadan is a multi-faceted package comprising a self-management and community awareness programme, and healthcare professional training. Implementation of the programme took place in two cities in the UK, prior to Ramadan 2017. Uptake and attendance were determined, and qualitative interviews and focus groups were completed with people attending the programme, and with various stakeholders involved in implementation and delivery. RESULTS: Success of the implementation varied and engagement by primary care was limited. Three central themes emerged from the interviews highlighting barriers and facilitators of the programme implementation. These were the referral pathway, programme content and feedback on the delivery of the programme. CONCLUSIONS: Provision of interventions that provide support and education for Muslims during Ramadan was implemented in communities and valued by GPs and practice nurses. However, heavy workloads to support delivery made it difficult for practices to engage. Recommendations for future delivery of the programme indicate that greater attention should be given to marketing and its supporting practices. Furthermore, training for practice nurses to support patients prior to Ramadan and provision of funding is required.

Users' experiences of a pragmatic diabetes prevention intervention implemented in primary care: qualitative study.

OBJECTIVES: To explore service-user and provider experience of the acceptability and value of the Let's Prevent Diabetes programme, a pragmatic 6-hour behavioural intervention using structured group education, introduced into primary care practice. DESIGN: Qualitative interview-based study with thematic analysis. SETTING: Primary care and community. PARTICIPANTS: Purposeful sample of 32 participants, including 22 people at high risk of diabetes who either attended, defaulted from or declined the intervention; and 10 stakeholder professionals involved in implementation. RESULTS: Participants had low prior awareness of their elevated risk and were often surprised to be offered intervention. Attenders were commonly older, white, retired and motivated to promote their health; who found their session helpful, particularly for social interaction, raising dietary awareness, and convenience of community location. However attenders highlighted lack of depth, repetition within and length of session, difficulty meeting culturally diverse needs and no follow-up as negative features. Those who defaulted from, or who declined the intervention were notably apprehensive, uncertain or unconvinced about whether they were at risk of diabetes; sought more specific information about the intervention, and were deterred by its group nature and day-long duration, with competing work or family commitments. Local providers recognised inadequate communication of diabetes risk to patients. They highlighted significant challenges for implementation, including resource constraints, and facilitation at individual general practice or locality level. CONCLUSIONS: This pragmatic diabetes prevention intervention was acceptable in practice, particularly for older, white, retired and health-motivated people. However, pre-intervention information and communication of diabetes risk should be improved to increase engagement and reduce potential fear or uncertainty, with closer integration of services, and more appropriate care pathways, to facilitate uptake and follow-up. Further development of this, or other interventions, is needed to enable wider, and more socially diverse, engagement of people at risk. Balancing a locality and individual practice approach, and how this is resourced are considerations for long-term sustainability.

Corrigendum and Editorial Warning Regarding Use of the MMAS Scale (The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial).

[This corrects the article DOI: 10.2196/11289.].

Baby Steps - a structured group education programme with accompanying mobile web application designed to promote physical activity in women with a history of gestational diabetes: study protocol for a randomised controlled trial.

BACKGROUND: A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM. METHODS: The study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation. DISCUSSION: If effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D. TRIAL REGISTRATION: ISRCTN, ISRCTN17299860 . Registered on 5 April 2017.

The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the Primary Prevention of Cardiovascular Disease: Protocol for a Randomized Controlled Trial.

BACKGROUND: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. OBJECTIVE: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. METHODS: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. RESULTS: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. CONCLUSIONS: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11289.

Physical Activity after Cardiac EventS (PACES) - a group education programme with subsequent text-message support designed to increase physical activity in individuals with diagnosed coronary heart disease: study protocol for a randomised controlled trial.

BACKGROUND: Coronary heart disease (CHD) represents approximately 13% of deaths worldwide and is the leading cause of death in the UK with considerable associated health care costs. After a CHD event, timely cardiac rehabilitation optimises patient outcomes. However, a high percentage of these services do not meet necessary performance indicators such as course length and follow-up attendance. Uptake of such services is only 50% in UK patients and support provided 12 months after an event is often limited. To delay and prevent further CHD events leading to hospitalisation, supplementary self-management strategies such as group education, are necessary. METHODS: This is a single-centre, randomised controlled trial (RCT) recruiting participants (n = 290) aged ≥18 years who are 12 to 48 months post diagnosis of a CHD-related cardiac event (myocardial infarction, angina and any other acute coronary syndrome). The study aims to implement a structured education programme, with text-message support over 12 months, and identify whether delivery of the programme, to individuals who have a history of a cardiac event, would be an effective and cost-effective strategy for increasing walking. The primary outcome, objectively measured average daily physical activity, specifically step count through walking activity, is assessed using the wrist-worn GENEActiv accelerometer at baseline, 6 and 12 months. Secondary outcomes at 12 months include cardiovascular risk factors such as smoking status, blood pressure, lipid profile, glycated haemoglobin (HbA1c), obesity, self-efficacy, quality of life, physical activity and physical function. Participants are randomised to either the control group receiving standard care and a physical activity information leaflet, or the intervention group whose partcipants receive the leaflet and are invited to attend two group-based structured education sessions. These encourage participants to adopt and maintain healthy behaviours and self-manage their lifestyle. They are delivered approximately 2 weeks apart by trained facilitators and reinforced via subsequent text-message support. DISCUSSION: To our knowledge, this is the first trial designed to assess the effectiveness of a group education programme 12 to 48 months after a CHD event diagnosis. If successful, the PACES programme could be translated into effective post-operative cardiac care and complement the current post-operative services available. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN91163727 . The trial was registered on 27 February 2017.

Movement through Active Personalised engagement (MAP) - a self-management programme designed to promote physical activity in people with multimorbidity: study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity, defined as two or more concurrent chronic diseases within the same individual, is becoming the clinical norm within primary care. Given the burden of multimorbidity on individuals, carers and health care systems, there is a need for effective self-management programmes. Promoting active participation within their clinical care and following a healthy lifestyle will help empower patients and target lifestyle factors that are exacerbating their conditions. The aim of this study is to establish whether a tailored, structured self-management programme can improve levels of physical activity at 12 months, in people with multimorbidity. METHODS/DESIGN: This study is a single-centre randomised controlled trial, with follow-up at 6 and 12 months. The primary outcome is change in objectively assessed average daily physical activity at 12 months. Secondary outcomes include medication adherence, lifestyle behaviours, quality of life, chronic disease self-efficacy and self-efficacy for exercise. Anthropometric and clinical measurements include blood pressure, muscle strength, lipid profile, kidney function and glycated haemoglobin (HbA1c). Participants are recruited from primary care. Those between 40 and 85 years of age with multimorbidity, with a good understanding of written and verbal English, who are able to give informed consent, have access to a mobile phone for use in study activities and are able to walk independently will be invited to participate. Multimorbidity is defined as two or more of the chronic conditions listed in the Quality and Outcomes Framework. A total of 338 participants will be randomly assigned, with stratification for gender and ethnicity, to either the control group, receiving usual care, or the intervention group, who are invited to the Movement through Active Personalised engagement programme. This involves attending four group-based self-management sessions aimed at increasing physical activity, mastering emotions, managing treatments and using effective communication. The sessions are delivered by trained facilitators, and regular text messages during the study period provide ongoing support. Changes in primary and secondary outcomes will be assessed, and an economic evaluation of the intervention undertaken. DISCUSSION: This study will provide new evidence on whether physical activity can be promoted alongside other self-management strategies in a multimorbid population and whether this leads to improvements in clinical, biomedical, psychological and quality of life outcomes. TRIAL REGISTRATION: ISRCTN, ISRCTN 42791781 . Registered on 14 March 2017.

The General Practitioner Prompt Study to Reduce Cardiovascular and Renal Complications in Patients With Type 2 Diabetes and Renal Complications: Protocol and Baseline Characteristics for a Cluster Randomized Controlled Trial.

BACKGROUND: Adherence to evidence-based cardiovascular risk factor targets in patients with type 2 diabetes and microalbuminuria has shown long-term reduction in mortality and morbidity. Strategies to achieve such adherence have been delivered at individual patient level and are not cost-effective. Health care professional-level intervention has the potential to promote better adherence at lower cost. OBJECTIVE: The aim of this study was to assess the effectiveness of a multifactorial technology-driven intervention comprising health care professional training, a software prompt installed on practice systems, clinician email support, and enhanced performance and feedback reporting. METHODS: A cluster randomized trial will be performed where the primary outcome is the proportion of eligible patients meeting tight cardiovascular risk factor targets, including systolic and diastolic blood pressure (BP; BP<130/80 mm Hg) and total cholesterol (TC; TC<3.5 mmol/L) at 24 months. Secondary outcomes include proportion of patients with glycated hemoglobin (HbA1c) <58 mmol/mol (7.5%), change in medication prescribing, changes in microalbuminuria and renal function (estimated glomerular filtration rate, eGFR), incidence of major adverse CV events and mortality, and coding accuracy. Cost-effectiveness of the intervention will also be assessed. RESULTS: Among 2721 eligible patients, mean age was 62.9 (SD 10.0) years, and duration of diabetes was 10.46 (SD 7.22) years. Mean HbA1c was 59.3 (SD 17.4) mmol/mol; mean systolic and diastolic BP (mm Hg) were 134.3 (SD 14.6) and 76.1 (SD 9.5) mm Hg, respectively; and mean TC was 4.1 (SD 0.98) mmol/L. Overall, 131 out of 2721 (4.81%) patients achieved all 3 "tight" cardiovascular risk factor targets. Cardiovascular risk factor burden increased two-fold in those with eGFR<60 mL/min/1.73 m2 compared with those with eGFR≥60 mL/min/1.73 m2. Prevalence of microalbuminuria was 22.76%. In total, 1076 out of 2721 (39.54%) patients were coded for microalbuminuria or proteinuria on their primary care medical record. CONCLUSIONS: The general practitioner prompt study is the largest UK primary care-based, technology-driven, randomized controlled trial to support intensive intervention in high-risk group of multiethnic individuals with type 2 diabetes and microalbuminuria. This paper provides contemporary estimates for prevalent cardiovascular disease and adherence to evidence-based cardiovascular risk factor targets at baseline in a population with type 2 diabetes and microalbuminuria. The main trial results, including cost-effectiveness data, will be submitted for publication in 2018. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN14918517; http://www.isrctn.com/ISRCTN14918517 (Archived by WebCite at http://www.webcitation.org/6zqm53wNA). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9588.