Predictors associated with an increase in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention.

BACKGROUND: This study aimed to explore predictors associated with intermediate (six months) and post-intervention (24 months) increases in daily steps among people with prediabetes or type 2 diabetes participating in a two-year pedometer intervention. METHODS: A secondary analysis was conducted based on data from people with prediabetes or type 2 diabetes from two intervention arms of the randomised controlled trial Sophia Step Study. Daily steps were measured with an ActiGraph GT1M accelerometer. Participants were divided into two groups based on their response to the intervention: Group 1) ≥ 500 increase in daily steps or Group 2) a decrease or < 500 increase in daily steps. Data from baseline and from six- and 24-month follow-ups were used for analysis. The response groups were used as outcomes in a multiple logistic regression together with baseline predictors including self-efficacy, social support, health-related variables, intervention group, demographics and steps at baseline. Predictors were included in the regression if they had a p-value < 0.2 from bivariate analyses. RESULTS: In total, 83 participants were included. The mean ± SD age was 65.2 ± 6.8 years and 33% were female. At six months, a lower number of steps at baseline was a significant predictor for increasing ≥ 500 steps per day (OR = 0.82, 95% CI 0.69-0.98). At 24 months, women had 79% lower odds of increasing ≥ 500 steps per day (OR = 0.21, 95% CI 0.05-0.88), compared to men. For every year of increase in age, the odds of increasing ≥ 500 steps per day decreased by 13% (OR = 0.87, 95% CI 0.78-0.97). Also, for every step increase in baseline self-efficacy, measured with the Self-Efficacy for Exercise Scale, the odds of increasing ≥ 500 steps per day increased by 14% (OR = 1.14, 95% CI 1.02-1.27). CONCLUSIONS: In the Sophia Step Study pedometer intervention, participants with a lower number of steps at baseline, male gender, lower age or higher baseline self-efficacy were more likely to respond to the intervention with a step increase above 500 steps per day. More knowledge is needed about factors that influence response to pedometer interventions. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02374788.

Mixed methods study on the feasibility of implementing periodic continuous glucose monitoring among individuals with type 2 diabetes mellitus in a primary care setting.

Background: Health care professionals (HCPs) play a central role in leveraging technologies to support individuals with diabetes. This mixed-method study was completed to determine the feasibility of implementing periodic continuous glucose monitoring (CGM) in a primary care setting. Aim: This study aimed to evaluate and describe the experiences of using periodic CGM with data visualization tools in patients with type 2 diabetes to foster a person-centered approach in a primary care setting. Methods: Fifty outpatients aged ≥18 years, diagnosed with type 2 diabetes, and with a disease duration of at least 2 years were included in this study. Data were collected from April 2021 to January 2022. Patients completed a single period of sensor measurements for 28 days and a diabetes questionnaire about feelings and experiences of health care. HbA1c was also measured. A focus group interview was conducted to evaluate and describe the HCPs experiences of using periodic CGM. Results: Patients reported to HCPs that the CGM device was comfortable to wear and noted that LibreView was easy to use when scanning the sensor to obtain and visualize the glucose levels and trends. Data availability of CGM data was >70 %.Clinical observations revealed a mean reduction in HbA1c, mmol/mol from 60.06 [7.65 %] at baseline to 55.42 [7.20 %] after 4 weeks (p < 0.001). Two categories were identified: 1) Fostering dialogue on self-care and 2) Promoting understanding. Conclusions: The HCPs and participants in this study had a positive experience or viewed the implementation of periodic CGM with data visualization tools as a positive experience and appeared to be feasible for implementation in a primary care setting.

The acceptability, usability, engagement and optimisation of a mHealth service promoting healthy lifestyle behaviours: A mixed method feasibility study.

Objective: Mobile health (mHealth) services suffer from high attrition rates yet represent a viable strategy for adults to improve their health. There is a need to develop evidence-based mHealth services and to constantly evaluate their feasibility. This study explored the acceptability, usability, engagement and optimisation of a co-developed mHealth service, aiming to promote healthy lifestyle behaviours. Methods: The service LongLife Active® (LLA) is a mobile app with coaching. Adults were recruited from the general population. Quantitative results and qualitative findings guided the reasoning for the acceptability, usability, engagement and optimisation of LLA. Data from: questionnaires, log data, eight semi-structured interviews with users, feedback comments from users and two focus groups with product developers and coaches were collected. Inductive content analysis was used to analyse the qualitative data. A mixed method approach was used to interpret the findings. Results: The final sample was 55 users (82% female), who signed up to use the service for 12 weeks. Engagement data was available for 43 (78%). The action plan was the most popular function engaged with by users. The mean scores for acceptability and usability were 3.3/5.0 and 50/100, respectively, rated by 15 users. Users expressed that the service's health focus was unique, and the service gave them a 'kickstart' in their behaviour change. Many ways to optimise the service were identified, including to increase personalisation, promote motivation and improve usability. Conclusion: By incorporating suggestions for optimisation, this service has the potential to support peoples' healthy lifestyle behaviours.

Psychosocial Self-efficacy and its Association with Selected Potential Factors Among Adults with Type 1 Diabetes: A Cross-Sectional Survey Study.

INTRODUCTION: The management of type 1 diabetes, a non-preventable chronic disease, leads to a high physical and psychological burden on the individual. Digital health technology can improve a person's psychosocial self-efficacy and thereby contribute to improved diabetes self-care. The aim of this study was to explore associations between psychosocial self-efficacy and demographic-, disease specific-, well-being as well as digital health technology (DHT) related factors among adults with type 1 diabetes. METHODS: A primarily web-based cross sectional survey was conducted among adults with type 1 diabetes in Sweden (n = 301). Psychosocial self-efficacy was assessed using the Swedish version of the Diabetes Empowerment Scale, Swe-DES-23. The survey also contained questions related to demographic-, disease specific-, well-being as well as digital health technology related variables. RESULTS: Higher well-being scores and lower HbA1c levels were associated with higher psychosocial self-efficacy in multiple linear regression analysis. In multivariate analysis, gender, body mass index, well-being scores, and HbA1c levels showed association with psychosocial self-efficacy. None of the DHT factors were found associated with psychosocial self-efficacy. CONCLUSIONS: In this study, higher well-being score and lower self-reported HbA1c levels were associated with higher psychosocial self-efficacy in both univariate- and multivariate analysis and accounted for 30% of the variation in psychosocial self-efficacy in the regression model. Thus, measures to improve psychosocial self-efficacy in adults with type 1 diabetes may help maintain their psychological well-being and blood glucose control.

Association between Weather and Self-Monitored Steps in Individuals with Prediabetes and Type 2 Diabetes in Sweden over Two Years.

BACKGROUND: Many studies have identified key factors affecting the rates of engagement in physical activity in older adults with chronic disease. Environmental conditions, such as weather variations, can present challenges for individuals with chronic diseases, such as type 2 diabetes when engaging in physical activity. However, few studies have investigated the influence of weather on daily steps in people with chronic diseases, especially those with prediabetes and type 2 diabetes. OBJECTIVE: This study investigated the association between weather variations and daily self-monitored step counts over two years among individuals with prediabetes and type 2 diabetes in Sweden. METHODS: The study is a secondary analysis using data from the Sophia Step Study, aimed at promoting physical activity among people with prediabetes and type 2 diabetes, which recruited participants from two urban primary care centers in Stockholm and one rural primary care center in southern Sweden over eight rounds. This study measured physical activity using step counters (Yamax Digiwalker SW200) and collected self-reported daily steps. Environmental factors such as daily average temperature, precipitation, and hours of sunshine were obtained from the Swedish Meteorological and Hydrological Institute. A robust linear mixed-effects model was applied as the analysis method. RESULTS: There was no association found between weather variations and the number of steps taken on a daily basis. The analysis indicated that only 10% of the variation in daily steps could be explained by the average temperature, precipitation, and sunshine hours after controlling for age, gender, and BMI. Conversely, individual factors explained approximately 38% of the variation in the observations. CONCLUSION: This study revealed that there was no association between weather conditions and the number of daily steps reported by individuals with prediabetes and type 2 diabetes taking part in a physical activity intervention over two years. Despite the weather conditions, women and younger people reported more steps than their male and older counterparts.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial.

OBJECTIVE: To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU). SETTING: An endocrinologic clinic in Sweden. PARTICIPANTS: In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18-70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals. INTERVENTION: The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action. OUTCOMES: The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group. RESULTS: Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (χ2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test χ2=12.63, p<0.001) was observed with improved scores on The Acceptance and Action Questionnaire in the intervention group after 1 and 2 years. CONCLUSIONS: No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study. TRIAL REGISTRATION NUMBER: NCT02914496.

Correlations between insulin-degrading enzyme and metabolic markers in patients diagnosed with type 2 diabetes, Alzheimer's disease, and healthy controls: a comparative study.

PURPOSE: This study aimed to explore correlations between insulin-degrading enzyme (IDE) and markers of metabolic function in a group of patients diagnosed with type 2 diabetes mellitus (T2DM) or Alzheimer's disease (AD) and metabolically healthy volunteers. METHOD: We included 120 individuals (47 with T2DM, 9 with AD, and 64 healthy controls). Serum levels of IDE were measured with commercial kits for ELISA. Differences in IDE levels between groups were analyzed with non-parametric ANCOVA, and correlations were analyzed with Spearman's rank correlations. We also investigated the influence of age, sex, and the use of insulin on the correlation using a non-parametric version of partial correlation. RESULTS: Patients diagnosed with T2DM had higher IDE levels than patients diagnosed with AD and healthy controls after adjustment for age and sex. IDE was increasingly associated with body mass index (BMI), fasting blood glucose, C-peptide, hemoglobin A1c (HbA1c), insulin resistance, and triglycerides. In stratified analyses, we found a decreasing partial correlation between IDE and HbA1c in patients diagnosed with AD and a decreasing partial correlation between IDE and C-peptide in healthy controls. In patients diagnosed with T2DM, we found no partial correlations. CONCLUSION: These results indicate that IDE is essential in metabolic function and might reflect metabolic status, although it is not yet a biomarker that can be utilized in clinical practice. Further research on IDE in human blood may provide crucial insights into the full function of the enzyme.

Psychometric Evaluation of the Swedish Acceptance and Action Diabetes Questionnaire: A Rasch Analysis.

Background and purpose: The Acceptance and Action Diabetes Questionnaire (AADQ) is a tool for assessing the acceptance of thoughts and emotions related to diabetes in people living with the disease. This study aimed to examine the psychometric properties of the Swedish version of AADQ (Swe-AADQ) in a sample of adults with type 1 diabetes. Methods: To examine the psychometric properties of the Swe-AADQ, the Rasch model was used. Data for 120 individuals were included. Results: The Swe-AADQ showed an acceptable fit to the Rasch model. A sufficiently high value of the separation index indicated a capacity to distinguish between different levels of acceptance in the sample. The seven-point Likert scale was reduced to three categories suggesting an improvement in the ordering of the item thresholds. Conclusions: The Swe-AADQ possesses reasonable quality in terms of reliability and validity. However, there are some deficiencies regarding the categorization of the response rating that should be addressed.

Living with Type 1 Diabetes as Experienced by Adults with Prolonged Elevated HbA1c: A Qualitative Study.

INTRODUCTION: High HbA1c levels in type 1 diabetes (T1D) are associated with increased risk of micro- and macrovascular complications and severe diabetes distress. A more comprehensive understanding of the adult perspective of living with T1D can improve the quality of care. We aimed to describe experiences of living with T1D as an adult with prolonged elevated HbA1c. METHODS: Thirteen adults with T1D and HbA1c > 60 mmol/mol (7.6%) for at least 1 year were individually interviewed via a digital platform. The interviews were transcribed verbatim and analyzed using qualitative content analysis. RESULTS: The analysis identified an overarching theme, "a lifelong follower", and generated two main categories describing study participants' experience: constraining and manageable. Constraining experiences were explained in obligated control, loss of control, environmental impact, and consequences of diabetes. Manageable experiences were described in everyday life, approach to diabetes, and support in life. Diabetes knowledge in health care and in the general public, and individualized care were important factors in feeling understood, safe, and supported. CONCLUSIONS: The findings revealed the diverse experiences of adults with prolonged elevated HbA1c. Living with T1D, a lifelong non-chosen follower, could be perceived as constraining but manageable in different degrees. A person-centered care approach addressing both dimensions may be beneficial. Experiences of living with and managing diabetes are multifaceted and intertwined with life context and medical prerequisites.

Patient Related Outcomes After Receiving a Person Centred Nurse Led Follow Up Programme Among Patients Undergoing Revascularisation for Intermittent Claudication: A Secondary Analysis of a Randomised Clinical Trial.

OBJECTIVE: The aim was to evaluate the effect of a person centred nurse led follow up programme on health related quality of life (HRQoL), health literacy, and general self efficacy compared with standard care for patients undergoing revascularisation for intermittent claudication (IC), and to describe factors associated with HRQoL one year after revascularisation. METHODS: This was a secondary analysis of a randomised controlled trial. Patients with IC scheduled for revascularisation at two vascular surgery centres in Sweden between 2016 and 2018 were randomised to intervention or control. During the first year after surgery, the intervention group received a person centred follow up programme with three visits and two telephone calls with a vascular nurse, while the control group received standard follow up with two visits to a vascular surgeon or vascular nurse. Outcomes were HRQoL measured by VascuQol-6, health literacy, and general self efficacy measured by validated questionnaires. RESULTS: Overall, 214 patients were included in the trial; this secondary analysis comprised 183 patients who completed the questionnaires. One year after revascularisation, HRQoL had improved with a mean increase in VascuQol-6 of 7.0 scale steps (95% CI 5.9 - 8.0) for the intervention and 6.0 scale steps (95% CI 4.9 - 7.0) for the control group; the difference between the groups was not significant (p = .18). In an adjusted regression analysis, the intervention was associated with higher VascuQoL-6 (2.0 scale steps, 95% CI 0.08 - 3.93). There was no significant difference between the groups regarding health literacy or general self efficacy. The prevalence of insufficient health literacy among all participants was 38.7% (46/119) at baseline and 43.2% (51/118) at one year. CONCLUSION: In this study, a person centred, nurse led follow up programme had no significant impact on HRQoL, health literacy, or general self efficacy among patients undergoing revascularisation for IC. The prevalence of insufficient health literacy was high and should be addressed by healthcare givers and researchers.

Health care professionals' experiences of supporting persons with metabolic risk factors to increase their physical activity level - a qualitative study in primary care.

OBJECTIVE: To be regularly physically active is of major importance for the health of people with metabolic risk factors. Many of these persons are insufficiently active and in need of support. This study aimed to explore barriers and facilitators perceived by health care professionals' within Swedish primary care in their work to support persons with metabolic risk factors to increase their physical activity. DESIGN: A qualitative design with focus group discussions was used. The data were analysed using qualitative content analysis with a manifest, inductive approach. SETTING: Primary health care in five Swedish healthcare regions. SUBJECTS: Nine physiotherapists, ten physicians and five nurses participated in six digital focus group discussions including two to six participants. RESULTS: Barriers and facilitators to supporting persons with metabolic risk factors to increase their physical activity were found within four generic categories, where the barriers and facilitators related to each generic category: 'Patient readiness for change', 'Supporting the process of change', 'The professional role', and 'The organisation of primary care'. CONCLUSION: The findings suggests that barriers and facilitators for supporting patients with metabolic risk factors can be found at several levels within primary care, from individual patient and the health care professionals to the organisational level. In the primary care setting, this should be highlighted when implementing support to increase physical activity in people with metabolic risk factors.KEY POINTSHealth care professionals within primary care are in a position to support people with metabolic risk factors to increase their physical activity.Barriers and facilitators to support the patients should be addressed at several levels within primary care.The study highlights factors on multiple levels such as professional responsibility, organisational prioritisation and resources, and the challenge to motivate behaviour change.

Perspectives on Promoting Physical Activity Using eHealth in Primary Care by Health Care Professionals and Individuals With Prediabetes and Type 2 Diabetes: Qualitative Study.

BACKGROUND: The trend of an exponential increase in prediabetes and type 2 diabetes (T2D) is projected to continue rising worldwide. Physical activity could help prevent T2D and the progression and complications of the disease. Therefore, we need to create opportunities for individuals to acquire the necessary knowledge and skills to self-manage their chronic condition through physical activity. eHealth is a potential resource that could facilitate self-management and thus improve population health. However, there is limited research on users' perception of eHealth in promoting physical activity in primary care settings. OBJECTIVE: This study aims to explore the perspectives of health care professionals and individuals with prediabetes and T2D on eHealth to promote physical activity in primary care. METHODS: A qualitative approach was applied using focus group discussions among individuals with prediabetes or T2D (14 participants in four groups) and health care professionals (10 participants in two groups). The discussions were audio-recorded and transcribed verbatim. Qualitative content analysis was used inductively to code the data. RESULTS: Three main categories emerged: utility, adoption process, and accountability. The utility of eHealth was described as a motivational, entertaining, and stimulating tool. Registration of daily medical measurements and lifestyle parameters in a cohesive digital platform was recognized as a potential resource for strengthening self-management skills. The adoption process includes eHealth to increase the accessibility of care and personalize the support of physical activity. However, participants stated that digital technology might only suit some and could increase health care providers' administrative burden. Accountability refers to the knowledge and skills to optimize eHealth and ensure data integrity and security. CONCLUSIONS: People with prediabetes and T2D and health care professionals positively viewed an integration of eHealth technology in primary care to promote physical activity. A cohesive platform using personal metrics, goal-setting, and social support to promote physical activity was suggested. This study identified eHealth illiteracy, inequality, privacy, confidentiality, and an increased workload on health care professionals as factors of concern when integrating eHealth into primary care. Continuous development of eHealth competence was reported as necessary to optimize the implementation of eHealth technology in primary care.

Effects of a person-centred, nurse-led follow-up programme on adherence to prescribed medication among patients surgically treated for intermittent claudication: randomized clinical trial.

BACKGROUND: Management of intermittent claudication should include secondary prevention to reduce the risk of cardiocerebrovascular disease. Patient adherence to secondary prevention is a challenge. The aim of this study was to investigate whether a person-centred, nurse-led follow-up programme could improve adherence to medication compared with standard care. METHODS: A non-blinded RCT was conducted at two vascular surgery centres in Sweden. Patients with intermittent claudication and scheduled for revascularization were randomized to the intervention or control (standard care) follow-up programme. The primary outcome, adherence to prescribed secondary preventive medication, was based on registry data on dispensed medication and self-reported intake of medication. Secondary outcomes were risk factors for cardiocerebrovascular disease according to the Framingham risk score. RESULTS: Some 214 patients were randomized and analysed on an intention-to-treat basis. The mean proportion of days covered (PDC) at 1 year for lipid-modifying agents was 79 per cent in the intervention and 82 per cent in the control group, whereas it was 92 versus 91 per cent for antiplatelet and/or anticoagulant agents. The groups did not differ in mean PDC (lipid-modifying P = 0.464; antiplatelets and/or anticoagulants P = 0.700) or in change in adherence over time. Self-reported adherence to prescribed medication was higher than registry-based adherence regardless of allocation or medication group (minimum P < 0.001, maximum P = 0.034). There was no difference in median Framingham risk score at 1 year between the groups. CONCLUSION: Compared with the standard follow-up programme, a person-centred, nurse-led follow-up programme did not improve adherence to secondary preventive medication. Adherence was overestimated when self-reported compared with registry-reported.

User Perceptions of eHealth and mHealth Services Promoting Physical Activity and Healthy Diets: Systematic Review.

BACKGROUND: Physical activity and a diet that follows general recommendations can help to prevent noncommunicable diseases. However, most adults do not meet current recommended guidelines, and support for behavior change needs to be strengthened. There is growing evidence that shows the benefits of eHealth and mobile health (mHealth) services in promoting healthy habits; however, their long-term effectiveness is uncertain because of nonadherence. OBJECTIVE: We aimed to explore users' perceptions of acceptability, engagement, and usability of eHealth and mHealth services that promote physical activity, healthy diets, or both in the primary or secondary prevention of noncommunicable diseases. METHODS: We conducted a systematic review with a narrative synthesis. We performed the literature search in PubMed, PsycINFO, and CINAHL electronic databases in February 2021 and July 2021. The search was limited to papers published in English between 2016 and 2021. Papers on qualitative and mixed method studies that encompassed eHealth and mHealth services for adults with a focus on physical activity, healthy diet, or both in the primary or secondary prevention of noncommunicable diseases were included. Three authors screened the studies independently, and 2 of the authors separately performed thematic analysis of qualitative data. RESULTS: With an initial finding of 6308 articles and the removal of 427 duplicates, 23 articles were deemed eligible for inclusion in the review. Based on users' preferences, an overarching theme-eHealth and mHealth services provide value but need to be tailored to individual needs-and 5 subthemes-interactive and integrated; varying and multifunctional; easy, pedagogic, and attractive; individualized and customizable; and reliable-emerged. CONCLUSIONS: New evidence on the optimization of digital services that promote physical activity and healthy diets has been synthesized. The findings represent users' perceptions of acceptability, engagement, and usability of eHealth and mHealth services and show that services should be personalized, dynamic, easily manageable, and reliable. These findings can help improve adherence to digital health-promoting services.

Increased levels of insulin-degrading enzyme in patients with type 2 diabetes mellitus.

PURPOSE: Decreasing levels of serum insulin-degrading enzyme (IDE) have been associated with an increased risk for Alzheimer´s disease (AD) in patients with type 2 diabetes mellitus (T2DM). Research on serum IDE levels in patients with T2DM is sparse and the aim of this study was to explore serum levels of IDE in patients with T2DM. METHOD: Blood serum samples were obtained from a biobank. Samples from subjects with T2DM and without metabolic disease were divided into subgroups; lifestyle treatment (n = 10), oral antidiabetic treatment (n = 17), insulin treatment (n = 20) and metabolically healthy controls (n = 18). Serum levels of IDE were analysed using specific ELISA assays. RESULTS: Serum levels of IDE were elevated in subjects with T2DM compared to metabolically healthy individuals (p = 0.033). No significant differences were detected between treatment subgroups. CONCLUSION: The present study indicates that patients with T2DM have increased serum IDE levels, compared to metabolically healthy individuals. However, for IDE to be clinically useful as a biomarker, its full function and possible use needs to be further elucidated in larger studies showing reproducible outcomes.

Implementing the Digital Diabetes Questionnaire as a Clinical Tool in Routine Diabetes Care: Focus Group Discussions With Patients and Health Care Professionals.

BACKGROUND: The Diabetes Questionnaire is a digital patient-reported outcome and experience measure for adults living with diabetes. The Diabetes Questionnaire is intended for use in routine clinical visits in diabetes care and to enable patient perspectives to be integrated into the Swedish National Diabetes Register. The Diabetes Questionnaire was developed on the basis of patients' perspectives, and evidence for its measurement qualities has been demonstrated. Patients receive an invitation to complete the questionnaire before clinical visits, and the patient and health care professional (HCP) can discuss the findings, which are instantly displayed during the visit. Implementation processes for new tools in routine care need to be studied to understand the influence of contextual factors, the support needed, and how patients and HCPs experience clinical use. OBJECTIVE: The aim of this study was to describe patients' and HCPs' experiences of initiating the use of the digital Diabetes Questionnaire as a clinical tool in routine diabetes care, supported by a structured implementation strategy involving initial education, local facilitators, and regular follow-ups. METHODS: In this qualitative study, semistructured focus group discussions were conducted 12 months after the use of the Diabetes Questionnaire was initiated. Participants were diabetes specialist nurses and physicians (20 participants in 4 groups) at hospital-based outpatient clinics or primary health care clinics and adults with type 1 or type 2 diabetes (15 participants in 4 groups). The audiotaped transcripts were analyzed using inductive qualitative content analysis. RESULTS: The results revealed 2 main categories that integrated patients' and HCPs' experiences, which together formed an overarching theme: While implementation demands new approaches, the Diabetes Questionnaire provides a broader perspective. The first main category (The Diabetes Questionnaire supports person-centered clinical visits) comprised comments expressing that the digital Diabetes Questionnaire can initiate and encourage reflection in preparation for clinical visits, bring important topics to light during clinical visits, and broaden the scope of discussion by providing additional information. The second main category (The process of initiating the implementation of the Diabetes Questionnaire) comprised comments that described differences in engagement among HCPs and their managers, challenges of establishing new routines, experiences of support during implementation, thoughts about the Diabetes Questionnaire, need to change local administrative routines, and opportunities and concerns for continued use. CONCLUSIONS: The Diabetes Questionnaire can broaden the scope of health data in routine diabetes care. While implementation demands new approaches, patients and HCPs saw potential positive impacts of using the questionnaire at both the individual and group levels. Our results can inform further development of implementation strategies to support the clinical use of the questionnaire.

Increasing patients' awareness of their own health: Experiences of participating in follow-up programs after surgical treatment for intermittent claudication.

INTRODUCTION: Claudication is the most usual symptom of peripheral artery disease, it is described as painful contractions in the leg when walking and alleviated upon resting. People with claudication have an added risk of cardiocerebrovascular events, amputation, and death. Adherence to medical treatment and changes in lifestyles can lower this risk, but this secondary prevention therapy requires engagement, participation, and adherence from the patient. OBJECTIVE: To explore patients' experiences of participating in a 1-year multicentre clinical trial with two follow-up programs evaluating a nurse-led, patient-centered health-promoting programme after surgical treatment for claudication, the FASTIC study. METHODS: A descriptive design with qualitative semi-structured interviews was used among participants in the FASTIC study. The study was conducted at two centres for vascular surgery in the city of Stockholm, Sweden. In all, 17 patients (nine men and eight women) who had completed the FASTIC study participated. Data was analysed using qualitative content analysis with an inductive approach. RESULTS: Two main categories were identified, 'Patient-Professional collaboration' and 'Experience of one´s health', which were associated with four subcategories: facing opportunities and obstacles, cooperating based on the illness experience, increasing awareness of one's own health, and maintaining a healthy lifestyle. CONCLUSIONS: Patients' participation in follow-up programs after surgical treatment for claudication is highly valuable for an increased awareness of one's own health. A person-centered care with patient-professional collaboration is experienced as important for maintaining a health-promoting lifestyle.

Physical Activity Patterns among Individuals with Prediabetes or Type 2 Diabetes across Two Years-A Longitudinal Latent Class Analysis.

BACKGROUND: This study aimed to identify distinct profiles of physical activity (PA) patterns among individuals with prediabetes or type 2 diabetes participating in a two-year PA trial and to investigate predictors of the profiles. METHODS: Data (n = 168, collected 2013-2020) from the cohort of a randomized trial aimed at increasing PA in individuals with prediabetes and type 2 diabetes were used. PA and sedentary behaviours were assessed by waist-worn ActiGraph GT1M accelerometers at baseline and at 6, 12, 18 and 24 months. Fifteen PA and sedentary variables were entered into a latent class mixed model for multivariate longitudinal outcomes. Multinominal regression analysis modelled profile membership based on baseline activity level, age, gender, BMI, disease status and group randomisation. RESULTS: Two profiles of PA patterns were identified: "Increased activity" (n = 37, 22%) included participants increasing time in PA and decreasing sedentary time. "No change in activity" (n = 131, 78%) included participants with no or minor changes. "Increased activity" were younger (p = 0.003) and more active at baseline (p = 0.011), compared to "No change in activity". No other predictor was associated with profile membership. CONCLUSIONS: A majority of participants maintained PA and sedentary patterns over two years despite being part of a PA intervention. Individuals improving PA patterns were younger and more active at baseline.

Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes-the Sophia Step Study.

BACKGROUND: This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. METHODS: The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. RESULTS: In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. CONCLUSION: This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02374788 . Registered 2 March 2015-Retrospectively registered.

Process evaluation of the Sophia Step Study- a primary care based three-armed randomized controlled trial using self-monitoring of steps with and without counseling in prediabetes and type 2 diabetes.

BACKGROUND: Describing implementation features of an intervention is required to compare interventions and to inform policy and best practice. The aim of this study was to conduct a process evaluation of the first 12 months of the Sophia Step Study: a primary care based RCT evaluating a multicomponent (self-monitoring of daily steps plus counseling) and a single component (self-monitoring of steps only) physical activity intervention to standard care on cardiometabolic health. METHODS: The evaluation was guided by the Medical Research Council Guidance for complex interventions. To describe the implementation communication with the health professionals implementing the interventions, attendance records and tracking of days with self-monitored pedometer-determined steps were used. Change in physical activity behaviour was measured at baseline, 6 and 12 months as daily steps by accelerometry. RESULTS: During April 2013 to January 2018 188 participants were randomized and intervened directly after inclusion. Response rate was 49% and drop out was 10%. A majority, 78%, had type 2 diabetes and 22% were diagnosed with prediabetes. Mean [Standard deviation (SD)] body mass index was 30.4 (4.4) kg/m2 and steps per day was 6566 (3086). The interventions were delivered as intended with minor deviation from the protocol and dose received was satisfying for both the multicomponent and single component group. The mean [95% Confidence Interval (CI)] change in daily steps from baseline to 6 months was 941(227, 1655) steps/day for the multicomponent intervention group, 990 (145, 1836) step/day for the single component group and - 506 (- 1118, 107) for the control group. The mean (95% CI) change in daily steps from baseline to 12 months was 31(- 507, 570) steps/day for the multicomponent intervention group, 144 (- 566, 853) step/day for the single component group and - 890 (- 1485, - 294) for the control group. There was a large individual variation in daily steps at baseline as well as in step change in all three groups. CONCLUSIONS: Applying self-monitoring of steps is a feasible method to implement as support for physical activity in the primary care setting both with and without counseling support. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02374788 . Registered 2 March 2015.