BACKGROUND: Digital interventions offering behaviour change support are warranted to prevent and treat non-communicable diseases, and have been evaluated rigorously in controlled settings. Effectivenss, factors influencing the uptake of scaled-up interventions-such as reach, received dose, usability and acceptability- and predictors and mediators of efficiency are rarely explored in research. The study described herein aims to evaluate the effectiveness of a personally tailored digital intervention (the app EviBody®), intended to support healthy and sustained lifestyle behaviours among the adult population, on well-being and behaviour change. Further aims are to explore context and uptake factors, predictors and mediators for behaviour change over 24 months.

METHODS: This is a real-world study, employing a quasi-experimental design and a process evaluation. EviBody® will be marketed and managed by its owner. A four-armed design will allow for comparison between three levels of intervention (basic, standard and premium) and a control group. Adults who sign up for the app will be invited to the research study including sharing app data and answering questionnaires at 0, 1, 3, 6, 12, 18, and 24 months. Study start is Autumn 2025. Controls (n = 200 to evaluate the primary endpoint well-being at 6 months) will be recruited through advertisements on social media and asked to answer the same questionnaires at 0 and 6 months provided by email. For predicting and mediating analyses the intention is to recruit 1500 app users. Well-being (measured with the WHO-5 Well-Being Index), goal achievement, physical activity, eating habits, mental health, mediators (motivation, self-efficacy, and perceived barriers), and demographics will be self-reported. Uptake will be collected using analytics and ratings of usability and acceptability, and described by demographics. Mixed models for repeated measures and structural equation modelling will be employed for data analysis.

DISCUSSION: Besides evaluating the effectivenss of a digital intervention, this study also applies a theory-based evaluation to understand which mediators are effective, for whom they are effective, and the specific conditions under which they are most beneficial.

TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT05973383 on 8 July 2023.

BACKGROUND: The use of digital health technology in diabetes self-care is increasing, making eHealth literacy an important factor to consider among people with type 1 diabetes. There are very few studies investigating eHealth literacy among adults with type 1 diabetes, highlighting the need to explore this area further.

OBJECTIVE: The aim of this study was to explore associations between eHealth literacy and demographic factors, disease-specific factors, and well-being among adults with type 1 diabetes.

METHODS: The study used data from a larger cross-sectional survey conducted among adults with type 1 diabetes in Sweden (N=301). Participants were recruited using a convenience sampling method primarily through advertisements on social media. Data were collected between September and November 2022 primarily through a web-based survey, although participants could opt to answer a paper-based survey. Screening questions at the beginning of the survey determined eligibility to participate. In this study, eHealth literacy was assessed using the Swedish version of the eHealth Literacy Scale (Sw-eHEALS). The predictor variables, well-being was assessed using the World Health Organization-5 Well-Being Index and psychosocial self-efficacy using the Swedish version of the Diabetes Empowerment Scale. The survey also included research group-developed questions on demographic and disease-specific variables as well as digital health technology use. Data were analyzed using multiple linear regression presented as nested models. A sample size of 270 participants was required in order to detect an association between the dependent and predictor variables using a regression model based on an F test. The final sample size included in the nested regression model was 285.

RESULTS: The mean Sw-eHEALS score was 33.42 (SD 5.32; range 8-40). The model involving both demographic and disease-specific variables explained 31.5% of the total variation in eHealth literacy and was deemed the best-fitting model. Younger age (P=.01; B=-0.07, SE=0.03;95% CI -0.12 to -0.02), lower self-reported glycated hemoglobin levels (P=.04; B=-0.06, SE=0.03; 95% CI -0.12 to 0.00), and higher psychosocial self-efficacy (P<.001; B=3.72, SE=0.53; 95% CI 2.68-4.75) were found associated with higher Sw-eHEALS scores when adjusted for demographic and disease-specific variables in this model. Well-being was not associated with eHealth literacy in this study.

CONCLUSIONS: The demographic and disease-specific factors explained the variation in eHealth literacy in this sample. Further studies in this area using newer eHealth literacy tools are important to validate our findings. The study highlights the importance of development and testing of interventions to improve eHealth literacy in this population for better glucose control. These eHealth literacy interventions should be tailored to meet the needs of people in varying age groups and with differing levels of psychosocial self-efficacy.

AIM: To evaluate the quality of care from the patients' perspective after receiving either person-centred, nurse-led follow-up or standard care after surgical treatment of intermittent claudication.

DESIGN: Secondary analysis of a randomised controlled trial.

METHODS: Patients at two centres for vascular surgery in Stockholm, Sweden were randomised to either a person-centred, nurse-led follow-up programme (intervention group) or a standard follow-up programme with surgeons. During their visits at 4 to 8 weeks and 1 year after surgery, they received the questionnaire Quality from patients' perspective with 28 items. The patients responded to each item from two aspects: (1) how they perceived the quality of received care and (2) subjective importance (how important the care was for them).

RESULTS: A total of 104 of 138 patients at 4-8 weeks and 159 of 193 patients at 1 year after surgery completed the questionnaire. At 4-8 weeks, the intervention group scored significantly higher perceived quality of care regarding five items: receiving useful information about "How I should take care of myself" and "Which nurse were responsible for my care", "Nurses were respectful towards me", "Nurses showed commitment/cared about me" and "Easy to get in contact with the clinic through telephone". At 1 year, the intervention group scored higher regarding two items: "Which nurses were responsible for my care" and "Next of kin treated well".

CONCLUSION: Person-centred, nurse-led follow-up as implemented in this study has been shown to lead to a higher perception of quality of care regarding information about self-care, the experience of being respected, and knowing the care provider responsible for their care. Thus, it could contribute towards improved patient satisfaction without compromising the perception of quality of care regarding other factors such as receiving the best medical care or timeliness.

IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: This study addresses how patients with intermittent claudication, who underwent revascularisation, perceive a follow-up care that is person-centred and nurse-led compared to standard care delivered by surgeons. The results indicate that patients find the person-centred and nurse-led follow-up programme satisfactory, with equal or higher quality of care and that follow-up can be delivered by nurses with retained patient safety. Thus, vascular units may consider transitioning follow-up care from surgeons to nurses while maintaining positive patient's perception of quality of care, patient satisfaction and safety.

REPORTING METHOD: Reporting of the work was made using the Consolidated Standards of Reporting Trials (CONSORT) statement.

PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

TRIAL REGISTRATION: Study Details | Person-centred Follow-up and Health Promotion Programme After Revascularization for Intermittent Claudication | ClinicalTrials.gov: NCT03283358.

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.

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.

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 HbA_1c, 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.

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.