BACKGROUND: Type 2 diabetes and prediabetes represent significant global health challenges, with physical activity (PA) being essential for disease management and prevention. Despite the well-documented benefits, many individuals with (pre)diabetes remain insufficiently active. General practitioners (GP) provide an accessible platform for delivering interventions; however, integrating PA interventions into routine care is hindered by resource constraints. OBJECTIVES: The ENERGISED trial aims to address these barriers through an innovative GP-initiated mHealth intervention combining wearable technology and just-in-time adaptive interventions. METHODS: The ENERGISED trial is a pragmatic, 12-month, multicentre, randomised controlled trial, assessing a GP-initiated mHealth intervention to increase PA and reduce sedentary behaviour in patients with type 2 diabetes and prediabetes. The primary outcome is daily step count, assessed via wrist-worn accelerometry. The primary analysis follows the intention-to-treat principle, using mixed models for repeated measures. Missing data will be handled under the missing-at-random assumption, with sensitivity analyses exploring robustness through reference-based multiple imputation. The trial incorporates the estimand framework to provide transparent and structured treatment effect estimation. DISCUSSION: This statistical analysis plan outlines a robust approach to addressing participant non-adherence, protocol violations, and missing data. By adopting the estimand framework and pre-specified sensitivity analyses, the plan ensures methodological rigour while enhancing the interpretability and applicability of results. CONCLUSIONS: The ENERGISED trial leverages innovative mHealth strategies within primary care to promote PA in individuals with (pre)diabetes. The pre-specified statistical framework provides a comprehensive guide for analysing trial data and contributes to advancing best practices in behavioural intervention trials for public health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05351359 . Registered on April 28, 2022.
- MeSH
- akcelerometrie MeSH
- cvičení * MeSH
- diabetes mellitus 2. typu * terapie psychologie diagnóza MeSH
- fitness náramky MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- nositelná elektronika MeSH
- pragmatické klinické studie jako téma MeSH
- praktické lékařství * metody MeSH
- prediabetes * terapie psychologie diagnóza MeSH
- sedavý životní styl * MeSH
- telemedicína * statistika a číselné údaje MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
BACKGROUND: Given the critical role of general practitioners (GPs), their insufficient medical density and the adverse effects of burnout on both practitioners and the quality of care provided, the prevalence estimates of GP burnout reported in the literature are highly concerning. This nationwide study builds on a 2023 survey that revealed a significant burden of burnout among Czech GPs. The primary objectives were to analyse the prevalence and determinants of burnout and to examine potential trends over time. METHODS: In April 2024, 2,500 randomly selected GPs were emailed the Maslach Burnout Inventory - Human Services Survey for Medical Personnel, supplemented with sociodemographic and job-related questions. The statistical analysis included a comparison with an identical study conducted a year earlier. RESULTS: Of the 765 completed responses (542 females, 223 males; mean age 55.5 years), 19.7% of the GPs experienced burnout in all three dimensions, 23% in two, 28.5% in one, and 28.8% in no dimension. Similar to 2023, the most common burnout dimension was a lack of personal accomplishment (PA, 52.2%), followed by emotional exhaustion (EE, 45.9%) and depersonalization (DP, 35.7%). Male and employed GPs experienced greater degrees of DP, while practice owners were more susceptible to EE. A positive dependence of burnout on the number of listed patients was identified. The proportion of GPs experiencing burnout across all dimensions decreased by 2.1% from 2023 to 2024 (p = 0.232), primarily in DP. Additionally, a 6.7% increase in GPs showing no signs of burnout in all dimensions (p = 0.002) further supported this positive trend. CONCLUSIONS: Between 2023 and 2024, the prevalence of burnout among GPs exhibited a modest decline. Nonetheless, it persists at almost 20%. Ensuring a sufficiently dense network of GPs, providing adequate resource allocation, and raising awareness of their importance are essential measures.
- MeSH
- depersonalizace epidemiologie psychologie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- pracovní uspokojení MeSH
- praktičtí lékaři * psychologie MeSH
- prevalence MeSH
- profesionální vyhoření * epidemiologie psychologie MeSH
- průzkumy a dotazníky MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Klíčová slova
- projekt PaRIS,
- MeSH
- chronická nemoc MeSH
- kvalita zdravotní péče * MeSH
- lidé MeSH
- poskytování zdravotní péče MeSH
- primární zdravotní péče MeSH
- průzkumy a dotazníky MeSH
- spokojenost pacientů * MeSH
- Check Tag
- lidé MeSH
BACKGROUND: The escalating global prevalence of type 2 diabetes and prediabetes presents a major public health challenge. Physical activity plays a critical role in managing (pre)diabetes; however, adherence to physical activity recommendations remains low. The ENERGISED trial was designed to address these challenges by integrating mHealth tools into the routine practice of general practitioners, aiming for a significant, scalable impact in (pre)diabetes patient care through increased physical activity and reduced sedentary behaviour. METHODS: The mHealth intervention for the ENERGISED trial was developed according to the mHealth development and evaluation framework, which includes the active participation of (pre)diabetes patients. This iterative process encompasses four sequential phases: (a) conceptualisation to identify key aspects of the intervention; (b) formative research including two focus groups with (pre)diabetes patients (n = 14) to tailor the intervention to the needs and preferences of the target population; (c) pre-testing using think-aloud patient interviews (n = 7) to optimise the intervention components; and (d) piloting (n = 10) to refine the intervention to its final form. RESULTS: The final intervention comprises six types of text messages, each embodying different behaviour change techniques. Some of the messages, such as those providing interim reviews of the patients' weekly step goal or feedback on their weekly performance, are delivered at fixed times of the week. Others are triggered just in time by specific physical behaviour events as detected by the Fitbit activity tracker: for example, prompts to increase walking pace are triggered after 5 min of continuous walking; and prompts to interrupt sitting following 30 min of uninterrupted sitting. For patients without a smartphone or reliable internet connection, the intervention is adapted to ensure inclusivity. Patients receive on average three to six messages per week for 12 months. During the first six months, the text messaging is supplemented with monthly phone counselling to enable personalisation of the intervention, assistance with technical issues, and enhancement of adherence. CONCLUSIONS: The participatory development of the ENERGISED mHealth intervention, incorporating just-in-time prompts, has the potential to significantly enhance the capacity of general practitioners for personalised behavioural counselling on physical activity in (pre)diabetes patients, with implications for broader applications in primary care.
- MeSH
- klinické praxe MeSH
- lidé MeSH
- primární zdravotní péče MeSH
- studium lékařství MeSH
- Check Tag
- lidé MeSH
