Effectiveness of the MyDiaMate application in reducing diabetes distress in adults with type 1 diabetes: Study protocol of the multi-national, randomised-controlled MyREMEDY trial.

AIMS: Diabetes distress is common among people with type 1 diabetes (T1D), negatively affecting quality of life, self management, and diabetes outcomes. E-health-based interventions could be an effective and low-cost way to improve the psychological care for people with T1D experiencing diabetes distress. The MyREMEDY study aims to test the effectiveness of the online unguided self-help intervention MyDiaMate in decreasing diabetes distress in adults with T1D. MyDiaMate is based on Cognitive Behavioural Therapy and consists of eight modules, each focusing on a different aspect of living with T1D that is often experienced as burdensome (e.g. hypoglycaemia, fatigue). METHODS: The effectiveness of MyDiaMate will be tested through a randomised-controlled trial across four European countries (the Netherlands, Germany, Spain and the United Kingdom). Six hundred and sixty adults (N = 165 per country) with T1D will be recruited and randomised with a balance of 2:1 into the intervention and care as usual groups. Intervention group members receive access to MyDiaMate for 6 months, care as usual group members receive access after 3 months for 3 months. Participants fill in questionnaires at 0 (baseline), 3 (effectiveness) and 6 months (follow-up). Primary outcome is diabetes distress at 3 months. Secondary outcomes are emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, fatigue, and glycaemic outcomes. Moreover, logdata of MyDiaMate use is passively collected. Linear mixed model analyses will be used to test the effectiveness of MyDiaMate along with identifying which user subgroup benefits most from MyDiaMate use. TRIAL REGISTRATION: Clinicaltrials.gov NCT06308549.

Face and content validity of the EMPOWER-UP questionnaire: a generic measure of empowerment in relational decision-making and problem-solving.

BACKGROUND: Decision-making and problem-solving processes are powerful activities occurring daily across all healthcare settings. Their empowering potential is seldom fully exploited, and they may even be perceived as disempowering. We developed the EMPOWER-UP questionnaire to enable assessment of healthcare users' perception of empowerment across health conditions, healthcare settings, and healthcare providers' professional backgrounds. This article reports the initial development of EMPOWER-UP, including face and content validation. METHODS: Four grounded theories explaining barriers and enablers to empowerment in relational decision-making and problem-solving were reviewed to generate a preliminary item pool, which was subsequently reduced using constant comparison. Preliminary items were evaluated for face and content validity using an expert panel of seven researchers and cognitive interviews in Danish and English with 29 adults diagnosed with diabetes, cancer, or schizophrenia. RESULTS: A preliminary pool of 139 items was reduced to 46. Independent feedback from expert panel members resulted in further item reduction and modifications supporting content validity and strengthening the potential for generic use. Forty-one preliminary items were evaluated through 29 cognitive interviews, resulting in a 36-item draft questionnaire deemed to have good face and content validity and generic potential. CONCLUSIONS: Face and content validation using an expert panel and cognitive interviews resulted in a 36-item draft questionnaire with a potential for evaluating empowerment in user-provider interactions regardless of health conditions, healthcare settings, and healthcare providers' professional backgrounds.

Users of healthcare services living with long-term health conditions may need empowerment-based support from healthcare providers to discover and develop their inherent capacity to be responsible for their own life. This ensures that healthcare users develop the skills needed to manage the many decisions and problems they face. Yet many healthcare users still experience lack of involvement and support in decision-making and problem-solving. Therefore, we developed the EMPOWER-UP questionnaire to allow healthcare users to evaluate the empowering qualities of their interactions with healthcare providers regardless of their diagnosis, where the interactions take place, and with whom. The aim of this article was to describe the development of EMPOWER-UP and to present the results of early evaluations of its content.The questionnaire was developed in Danish based on thorough qualitative research explaining distinct, complex patterns in user-provider interactions and translated to English during the evaluation process. We used individual feedback from a panel of expert researchers and interviews conducted with healthcare users diagnosed with diabetes, cancer, or schizophrenia to evaluate EMPOWER-UP's content. Interviews were conducted while the participants answered preliminary versions of the questionnaire.As a result of these evaluations, several items in the questionnaire were adjusted, some were deleted, and some new items were developed. We believe that EMPOWER-UP can be an important tool to help evaluate the effectiveness of interventions aimed at ensuring empowering support from healthcare providers. Thus, EMPOWER-UP may help to identify the most effective interventions for specific healthcare contexts.

Interventions to enhance pre-pregnancy care for women with type 2 diabetes: A systematic review of the literature.

AIMS: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre-pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. METHODS: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre-pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full-text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta-analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. RESULTS: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%-40%) and none of the interventions were exclusively tailored for them. The uptake of pre-pregnancy care was lower in women with type 2 diabetes (8%-10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre-pregnancy care, with varying impact on pregnancy outcomes. CONCLUSIONS: This review demonstrates that previous interventions have had a limited impact on pre-pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre-pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities.

The relationships between caregivers' self-reported and visual perception of child weight and their non-responsive feeding practices: A systematic review and meta-analysis.

BACKGROUND: The impacts of caregivers' perception of child weight on their non-responsive feeding practices are inconclusive. This systematic review aimed to examine their relationships. METHODS: A systematic search of five databases was conducted from inception to March 2022, following PRISMA guidelines. Data synthesis was performed using semi-quantitative approach and meta-analysis. RESULTS: Twenty-two studies with 12005 respondents were included for semi-quantitative analyses. Eighteen studies examined 26 associations between caregivers' perception of child weight and food restriction with 12 statistically significant associations being observed. A total of 22 relationships between caregivers' perception of child weight and pressure to eat were investigated, with 13 being statistically significant. The statistically significant associations consistently reported that caregivers' visual and self-reported perception of child weight was positively associated with their restrictive feeding and negatively associated with pressure to eat. The pooled odds ratios (ORs) indicated that caregivers who perceived their child as overweight were found to apply pressure to eat less frequently (OR = 0.61; 95%CI: 0.44, 0.84) compared with those who did not. However, caregivers' perception of child weight was not statistically significantly associated with restrictive feeding (OR = 1.37; 95%CI: 0.74, 2.55). CONCLUSION: Caregivers' self-reported and visual perception of child weight may be important risk factors for non-responsive feeding practices, particularly food restriction and pressure to eat. Thus, interventions need to consider the role of caregivers' perception of child weight, which may optimize feeding practices. Furthermore, longitudinal and intervention-based studies using validated measurements while controlling for potential covariates are needed to provide more evidence on their causal relationships.

Delegation of insulin administration to non-registered healthcare workers in community nursing teams: A qualitative study.

AIMS: To explore stakeholder perspectives on the benefits and/or disadvantages of the delegation of insulin injections to healthcare support workers in community nursing services. DESIGN: Qualitative case study. METHODS: Interviews with stakeholders purposively sampled from three case sites in England. Data collection took place between October 2020 and July 2021. A reflexive thematic approach to analysis was adopted. RESULTS: A total of 34 interviews were completed: patients and relatives (n = 7), healthcare support workers (n = 8), registered nurses (n = 10) and senior managers/clinicians (n = 9). Analysis resulted in three themes: (i) Acceptance and confidence, (ii) benefits and (iii) concerns and coping strategies. Delegation was accepted by stakeholders on condition that appropriate training, supervision and governance was in place. Continuing contact between patients and registered nurses, and regular contact between registered nurses and healthcare support workers was deemed essential for clinical safety. Services were reliant on the contribution of healthcare support workers providing insulin injections, particularly during the COVID-19 pandemic. Benefits for service and registered nurses included: flexible team working, increased service capacity and care continuity. Job satisfaction and career development was reported for healthcare support workers. Patients benefit from timely administration, and enhanced relationships with the nursing team. Concerns raised by all stakeholders included potential missed care, remuneration and task shifting. CONCLUSION: Delegation of insulin injections is acceptable to stakeholders and has many benefits when managed effectively. IMPACT: Demand for community nursing is increasing. Findings of this study suggest that delegation of insulin administration contributes to improving service capacity. Findings highlight the essential role played by key factors such as appropriate training, competency assessment and teamwork, in developing confidence in delegation among stakeholders. Understanding and supporting these factors can help ensure that practice develops in an acceptable, safe and beneficial way, and informs future development of delegation practice in community settings. PATIENT OR PUBLIC CONTRIBUTION: A service user group was consulted during the design phase prior to grant application and provided comments on draft findings. Two people with diabetes were members of the project advisory group and contributed to the study design, development of interview questions, monitoring study progress and provided feedback on study findings.

Needs, concerns and self-management experiences of people with type 2 diabetes during the COVID-19 pandemic: A qualitative study.

BACKGROUND: Type 2 diabetes is associated with increased COVID-19 severity. Little is understood about the needs, concerns and self-management experiences of people with type 2 diabetes during the COVID-19 pandemic. AIM: To examine the lived experiences of people with type 2 diabetes during the COVID-19 pandemic. METHOD: This qualitative study recruited people with type 2 diabetes from the SOUth-London Diabetes (SOUL-D) cohort. Semi-structured interviews via telephone were conducted between September 2020 and January 2021. Deductive thematic analysis derived themes from the data to explore needs, concerns and self-management experiences of people with type 2 diabetes. RESULTS: Twenty-nine people with type 2 diabetes were interviewed. Three themes with subthemes were outlined: (1) information needs of people with type 2 diabetes during the Covid-19 pandemic, (2) concerns about Covid-19 from people with type 2 diabetes and (3) diabetes self management and well-being during the Covid-19 pandemic. CONCLUSION: During a pandemic, there is a need for consistent, diabetes-specific, messaging from healthcare professionals for people with type 2 diabetes. People with type 2 diabetes need support to access digital resources to aid remote communication. Future research could help develop recourses to prevent social isolation and loneliness for people with type 2 diabetes during a pandemic.

Eliciting the mechanisms of action of care navigators in the management of type 2 diabetes in people with severe mental illness: A qualitative study.

BACKGROUND: People with severe mental illness and type 2 diabetes have a reduced life expectancy compared to the general population. One factor that contributes to this is the inability to provide optimal management, as the two conditions are typically managed by separate physical and mental health systems. The role of care navigators in coordinating diabetes care in people with severe mental illness may provide a solution to better management. AIM: To explore the views of clinicians and people with severe mental illness and type 2 diabetes on an integrated health service model with a focus on the care navigator to identify potential mechanisms of action. DESIGN: Qualitative one-to-one semi-structured interviews and part of a wider pilot intervention study. SETTING: Community Mental Health Unit in South London. METHOD: Topic guides explored the perspectives and experiences of both clinicians and people with severe mental illness and diabetes. Data analysis was conducted using Thematic Analysis. RESULTS: From the analysis of 19 participants, five main themes emerged regarding the care navigator role: administrative service; signposting to local services; adhering to lifestyle changes and medication; engaging in social activities; further skills and training needed. The key findings from this study emphasise the benefits that the role of a care navigator has in helping people with severe mental illness to better manage their diabetes i.e. through diet, exercise medication and attending essential health check-ups. CONCLUSION: This study illustrates that having a care navigator in place empowers those with severe mental illness to improve the management of their diabetes. Future research should focus on the extent to which care navigators are effective in improving specific outcomes.

Sexual health and function in women with diabetes.

Sexual dysfunction for women with diabetes is more common than for women without diabetes. The reasons why women with diabetes are a high-risk group are numerous. For example, lack of vaginal lubrication, pain during sex and inability to orgasm can be a consequence of high or low blood glucose levels. Higher rates of depression in people with diabetes can lead to low sexual drive. Wearing of diabetes devices, such as pumps, glucose monitors or lumps from lipohypertrophy around insulin injection sites may affect body image and self-esteem and the inconvenience of self-managing diabetes may affect the spontaneity of sex. This narrative review provides an overview of the problem of sexual dysfunction in women with diabetes, current methods of assessing sexual dysfunction in women, pharmacological and non-pharmacological interventions to treat it and an example of how psychological support for women with diabetes who experience sexual dysfunction can be integrated into a diabetes service. There are still significant gaps in our knowledge of how best to support women with diabetes and sexual dysfunction. However, raising awareness of the problem may help women with diabetes and healthcare professionals to discuss it as part of diabetes clinical consultations.

Psychological interventions for treating foot ulcers, and preventing their recurrence, in people with diabetes.

BACKGROUND: Diabetic foot ulceration (DFU) can be defined as a full-thickness wound below the ankle and is a major complication of diabetes mellitus. Despite best practice, many wounds fail to heal, and when they do, the risk of recurrence of DFU remains high. Beliefs about personal control, or influence, on ulceration are associated with better engagement with self-care in DFU. Psychological interventions aim to reduce levels of psychological distress and empower people to engage in self-care, and there is some evidence to suggest that they can impact positively on the rate of wound healing. OBJECTIVES: To evaluate the effects of psychological interventions on healing and recurrence of DFU. SEARCH METHODS: In September 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, Ovid PsycINFO and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and reviewed reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that evaluated psychological interventions compared with standard care, education or another psychological intervention. Our primary outcomes were the proportion of wounds completely healed; time to complete wound healing; time to recurrence and number of recurrences. DATA COLLECTION AND ANALYSIS: Four review authors independently screened titles and abstracts of the studies identified by the search strategy for eligibility. Three authors independently screened all potentially relevant studies using the inclusion criteria and carried out data extraction, assessment of risk of bias and GRADE assessment of the certainty of the evidence. MAIN RESULTS: We identified seven trials that met the inclusion criteria with a total of 290 participants: six RCTs and one quasi-RCT. The studies were conducted in Australia, the USA, the UK, Indonesia, Norway and South Africa. Three trials used a counselling-style intervention and one assessed an intervention designed to enhance an understanding of well-being. One RCT used a biofeedback relaxation training intervention and one used a psychosocial intervention based on cognitive behavioural therapy. A quasi-RCT assessed motivation and tailored the intervention accordingly. Due to the heterogeneity of the trials identified, pooling of data was judged inappropriate, and we therefore present a narrative synthesis. Comparisons were (1) psychological intervention compared with standard care and (2) psychological intervention compared with another psychological intervention. We are uncertain whether there is a difference between psychological intervention and standard care for people with diabetic foot ulceration in the proportion of wounds completely healed (two trials, data not pooled, first trial RR 6.25, 95% CI 0.35 to 112.5; 16 participants, second trial RR 0.59, 95% CI 0.26 to 1.39; 60 participants), in foot ulcer recurrence after one year (two trials, data not pooled, first trial RR 0.67, 95% CI 0.32 to 1.41; 41 participants, second trial RR 0.63, 95% CI 0.05 to 7.90; 13 participants) or in health-related quality of life (one trial, MD 5.52, 95% CI -5.80 to 16.84; 56 participants). This is based on very low-certainty evidence which we downgraded for very serious study limitations, risk of bias and imprecision. We are uncertain whether there is a difference in the proportion of wounds completely healed in people with diabetic foot ulceration depending on whether they receive a psychological intervention compared with another psychological intervention (one trial, RR 2.33, 95% CI 0.92 to 5.93; 16 participants). This is based on very low-certainty evidence from one study which we downgraded for very serious study limitations, risk of bias and imprecision. Time to complete wound healing was reported in two studies but not in a way that was suitable for inclusion in this review. One trial reported self-efficacy and two trials reported quality of life, but only one reported quality of life in a manner that enabled us to extract data for this review. No studies explored the other primary outcome (time to recurrence) or secondary outcomes (amputations (major or distal) or cost). AUTHORS' CONCLUSIONS: We are unable to determine whether psychological interventions are of any benefit to people with an active diabetic foot ulcer or a history of diabetic foot ulcers to achieve complete wound healing or prevent recurrence. This is because there are few trials of psychological interventions in this area. Of the trials we included, few measured all of our outcomes of interest and, where they did so, we judged the evidence, using GRADE criteria, to be of very low certainty.

Isolated low toe-brachial index is associated with increased mortality and morbidity: a retrospective cohort study.

OBJECTIVE: The aim was to assess the prognostic impact of perfusion assessments including ankle-brachial Index (ABI) and toe-brachial Index (TBI) on survival of patients who present with diabetic foot ulceration and to analyse clinical outcomes when patients are categorised into three levels of limb ischaemia. METHOD: This was a retrospective cohort analysis of consecutive patients presenting with foot ulceration. Patients continued with their standard of care, after having baseline assessments of limb perfusion. Patients were retrospectively categorised into three groups according to baseline ABI and TBI: Group 1 (n=31) non-ischaemic (TBI≥0.75, ABI≥0.9), Group 2 (n=67) isolated low TBI with foot ischaemia (TBI<0.75, ABI≥0.90) and Group 3 (n=30) foot-leg ischaemia (TBI<0.75, ABI<0.90). RESULTS: A total of 128 patients took part in the study. Low TBI was associated with a significant decrease in patient survival (42±20 versus 51±16 months, p=0.011). There was a progressive and significant decline in mean patient survival time (51±16 versus 44±20 versus 39±22 months, respectively, for ANOVA across the three groups, p=0.04). Patients with isolated low TBI had angioplasty and bypass at a rate similar to that of patients in Group 3 (low ABI and low TBI). The proportion of angioplasties was significantly higher in the isolated low TBI (19.4% (13/67) versus the non-ischaemic 3.2% (1/31), p=0.033). Such revascularisation resulted in ulcer healing within the foot ischaemic group that was similar to the non-ischaemic group (68% versus 60% over 12 months, p=0.454). CONCLUSION: Regardless of ABI level, measurement of TBI identifies patients with isolated low TBI who require specialised care pathways and revascularisation to achieve ulcer healing that is similar to non-ischaemic patients.

Online Acceptance and Commitment Therapy for People with Painful Diabetic Neuropathy in the United Kingdom: A Single-Arm Feasibility Trial.

OBJECTIVE: This study aimed to assess the feasibility of online Acceptance and Commitment Therapy for painful diabetic neuropathy in the United Kingdom and to determine if a larger randomized controlled trial testing treatment efficacy is justified. METHODS: Participants with painful diabetic neuropathy were recruited online and from hospital services. This was a single-arm study in which all participants received online Acceptance and Commitment Therapy. Participants completed questionnaires at baseline and three months post-treatment. Primary feasibility outcomes were recruitment, retention, and treatment completion rates. Secondary outcomes were pre- to post-treatment effects on pain outcomes and psychological flexibility. RESULTS: Of 225 potentially eligible participants, 30 took part in this study. Regarding primary feasibility outcomes, the treatment completion and follow-up questionnaire completion rates were 40% and 100%, respectively. Generally, at baseline those who completed the treatment, compared with those who did not, had better daily functioning and higher psychological flexibility. With respect to secondary outcomes, results from the completers group showed clinically meaningful effects at post-treatment for 100% of participants for pain intensity and pain distress, 66.7% for depressive symptoms, 58.3% for functional impairment, 41.7% for cognitive fusion, 66.7% for committed action, 58.3% for self-as-context, and 41.7% for pain acceptance. CONCLUSIONS: This preliminary trial suggests feasibility of recruitment and follow-up questionnaire completion rates, supporting planning for a larger randomized controlled trial. However, treatment completion rates did not achieve the prespecified feasibility target. Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.

Shortening self-report mental health symptom measures through optimal test assembly methods: Development and validation of the Patient Health Questionnaire-Depression-4.

BACKGROUND: The objective of this study was to develop and validate a short form of the Patient Health Questionnaire-9 (PHQ-9), a self-report questionnaire for assessing depressive symptomatology, using objective criteria. METHODS: Responses on the PHQ-9 were obtained from 7,850 English-speaking participants enrolled in 20 primary diagnostic test accuracy studies. PHQ unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible length between one and eight items, including and excluding the ninth item. The final short form was selected based on prespecified validity, reliability, and diagnostic accuracy criteria. RESULTS: A four-item short form of the PHQ (PHQ-Dep-4) was selected. The PHQ-Dep-4 had a Cronbach's alpha of 0.805. Sensitivity and specificity of the PHQ-Dep-4 were 0.788 and 0.837, respectively, and were statistically equivalent to the PHQ-9 (sensitivity = 0.761, specificity = 0.866). The correlation of total scores with the full PHQ-9 was high (r = 0.919). CONCLUSION: The PHQ-Dep-4 is a valid short form with minimal loss of information of scores when compared to the full-length PHQ-9. Although OTA methods have been used to shorten patient-reported outcome measures based on objective, prespecified criteria, further studies are required to validate this general procedure for broader use in health research. Furthermore, due to unexamined heterogeneity, there is a need to replicate the results of this study in different patient populations.

Psychosocial Factors in Painful Diabetic Neuropathy: A Systematic Review of Treatment Trials and Survey Studies.

OBJECTIVE: Diabetes mellitus is associated with a number of complications that can adversely impact patients' quality of life. A common and often painful complication is painful diabetic neuropathy. The aims of this study were to systematically review and summarize evidence from studies of psychological treatments and psychosocial factors related to painful diabetic neuropathy and assess the methodological quality of these studies. METHODS: Electronic databases, related reviews, and associated reference lists were searched. Summaries of participants' data relating to the efficacy of psychological treatments and/or to associations between psychosocial factors and outcomes in painful diabetic neuropathy were extracted from the included studies. The methodological quality of included studies was assessed using two standardized quality assessment tools. RESULTS: From 2,921 potentially relevant titles identified, 27 studies were included in this systematic review. The evidence suggests that depression, anxiety, sleep, and quality of life are the most studied variables in relation to pain outcomes in painful diabetic neuropathy and are consistently associated with pain intensity. The magnitude of the associations ranged from small to large. CONCLUSIONS: Research into psychosocial factors in painful diabetic neuropathy is unexpectedly limited. The available evidence is inconsistent and leaves a number of questions unanswered, particularly with respect to causal associations between variables. The evidence reviewed indicates that depression, anxiety, low quality of life, and poor sleep are associated with pain in painful diabetic neuropathy. The disproportionate lack of research into psychological treatments for painful diabetic neuropathy represents a significant opportunity for future research.

Response bias to a randomised controlled trial of a lifestyle intervention in people at high risk of cardiovascular disease: a cross-sectional analysis.

BACKGROUND: Research evaluating lifestyle interventions for prevention of cardiovascular disease (CVD) may not reach those most at risk. We compared the response rate to a randomised controlled trial (RCT) of a lifestyle intervention by CVD risk, ethnicity and level of deprivation. METHODS: Primary care patients with a QRisk2 score ≥ 20% were invited to participate in a RCT of an intensive lifestyle intervention versus usual care. This cross-sectional analysis compares anonymised data of responders and non-responders with multiple logistic regression, using adjusted odds ratios (AORs) for QRisk2 score, ethnicity, Index of Multiple Deprivation (IMD 2010) quintile, age and sex. RESULTS: From 60 general practices, 8902 patients were invited and 1489 responded. The mean age was 67.3 years and 21.0% were female. Of all patients invited, 69.9% were of white ethnic background, 13.9% ethnic minority backgrounds and 16.2% had no ethnicity data recorded in their medical records. Likelihood of response decreased as QRisk2 score increased (AOR 0.82 per 5 percentage points, 95% CI 0.77-0.88). Black African or Caribbean patients (AOR 0.67; 95% CI 0.45-0.98) and those with missing ethnicity data (AOR 0.55; 95% CI 0.46-0.66) were less likely to respond compared to participants of white ethnicity, but there was no difference in the response rates between south Asian and white ethnicity (AOR 1.08; 95% CI 0.84-1.38). Patients residing in the fourth (AOR 0.70; 95% CI 0.56-0.87) and fifth (AOR 0.52; 95% CI 0.40-0.68) most deprived IMD quintile were less likely to respond compared to the least deprived quintile. CONCLUSIONS: Evaluations of interventions intended for those at high risk of CVD may fail to reach those at highest risk. Hard to reach patient groups may require different recruitment strategies to maximise participation in future trials. Improvements in primary care ethnicity data recording is required to aid understanding of how successfully study samples represent the target population. TRIAL REGISTRATION: ISRCTN, ISRCTN84864870. Registered 15 May 2012, https://doi.org/10.1186/ISRCTN84864870 .

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

BACKGROUND: Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. METHODS: Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. RESULTS: After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). CONCLUSIONS: After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills. TRIAL REGISTRATION: ISRCTN75776892 ; date registered: 19/05/2010.

The association of depressive symptoms and diabetes distress with glycaemic control and diabetes complications over 2 years in newly diagnosed type 2 diabetes: a prospective cohort study.

AIMS/HYPOTHESIS: We examined the associations between depressive symptoms and diabetes distress with glycaemic control and diabetes complications over 2 years, after diagnosis of type 2 diabetes. METHODS: In a multi-ethnic, primary care cohort (n = 1735) of adults, all with recent (<6 months) diagnosis of type 2 diabetes, we measured the associations between depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] score ≥10) and diabetes distress (Problem Areas in Diabetes [PAID] score ≥40), with change in 2 year HbA1c as the primary outcome and with incident rates of diabetes complications as secondary outcomes. Multivariate models were used to account for potential confounders. RESULTS: Of the 1651 participants (95.2%) of the total primary care cohort with available baseline PHQ-9 and PAID scores, mean ± SD age was 56.2 ± 11.1 years, 55.1% were men and 49.1% were of non-white ethnicity; 232 (14.1%) and 111 (6.7%) had depressive symptoms and diabetes distress, respectively. After adjustment for confounders, depressive symptoms were not associated with worsening HbA1c. After adjustment for age, sex, ethnicity, vascular risk factors and diabetes treatments, depressive symptoms were associated with increased risk of incident macrovascular complications (OR 2.78 [95% CI 1.19, 6.49], p = 0.018) but not microvascular complications. This was attenuated (p = 0.09) after adjustment for IL-1 receptor antagonist concentration. Diabetes distress was not associated with worsening HbA1c or incident complications. CONCLUSIONS/INTERPRETATION: In the first 2 years of type 2 diabetes, the effect of depressive symptoms and diabetes distress on glycaemic control is minimal. There was, however, an association between depressive symptoms and incidence of macrovascular complications. Elevated innate inflammation may be common to both depression and macrovascular diabetes complications, but these findings require replication.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

OBJECTIVE: Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. METHODS: The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. RESULTS: Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. CONCLUSION: A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

Empowering parents to optimize feeding practices with preschool children (EPO-Feeding): A study protocol for a feasibility randomized controlled trial.

BACKGROUND: Parental feeding practices (PFPs) play a key role in fostering preschoolers' dietary habits and in mitigating the risk of childhood obesity. Nevertheless, parents often employ inappropriate feeding practices, leading to children's potential nutrition-related issues. Thus, research is needed to inform interventions that focus on optimizing feeding practices. METHODS: This protocol describes the evaluation of a novel intervention-Empowering Parents to Optimize Feeding Practices (EPO-Feeding Program). The program will be evaluated with a two-arm feasibility randomized controlled trial (RCT) in Yangzhou, China. The program includes four weekly group-based training sessions led by healthcare professionals for parents of preschool children. The intervention incorporates sessions, group discussions, motivational interviewing, and supplementary materials (e.g., key messages and educational videos) aimed at enhancing parents' knowledge, skills, and behaviours related to feeding practices. The primary outcomes include i) implementation feasibility, primarily assessed through retention rates; and ii) program acceptability through a survey and qualitative process evaluation. Secondary outcomes encompass the potential impacts on i) PFPs, ii) parental perception of child weight (PPCW), iii) parenting sense of competence, iv) children's eating behaviours, and v) child weight status. Quantitative analyses include descriptive estimates for evaluating the feasibility and linear mixed regression analysis for testing the potential effects. Qualitative valuation will use thematic framework analysis. DISCUSSION: If this study shows this program to be feasible to implement and acceptable to parents, it will be used to inform a fully powered trial to determine its effectiveness. The research will also help inform policy and practices in the context of child nutrition promotion, particularly regarding implementing group-based training sessions by healthcare providers in similar settings. TRIAL REGISTRATION: Clinicaltrials.gov, Protocol #NCT06181773, 20/11/2023.

The effectiveness of interventions on changing caregivers' feeding practices with preschool children: A systematic review and meta-analysis.

Caregivers' feeding practices are critical in shaping preschool children's eating habits and preventing childhood obesity. We conducted a systematic review and meta-analysis to evaluate the effectiveness of existing interventions targeting caregivers of preschool children, which aimed to promote child healthy eating and/or manage child weight and/or prevent child nutrition-related problems and included feeding practices as one of the outcomes. Eighteen studies with 18 intervention programs and 3887 respondents that completed baseline evaluations were eligible for data synthesis. Behavior change techniques (BCTs) frequently used included the following: instruction on how to perform the behavior and demonstration of the behavior. The pooled effects of randomized controlled trials (RCTs) on pressure to eat (pooled standardized mean difference [SMD] = 0.61; 95%CI: -1.16, -0.06), use of food as a reward (pooled SMD = -0.31; 95%CI: -0.61, -0.01), and emotional feeding (pooled SMD = -0.36; 95%CI: -0.66, -0.06) were found statistically significant compared with control groups at post-intervention. However, there were no pooled effects on restrictive feeding and pressure to eat at other follow-ups or on other feeding practices at post-intervention. Interventions may have short-term effects on decreasing the adoption of coercive control. Future interventions should directly and adequately optimize feeding practices, include components of individual support, and contribute to the maintenance of the effects over the long term.