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.
- Klíčová slova
- Accelerometer, Adherence, Estimand framework, Fitbit, GGIR, Just-in-time adaptive intervention (JITAI), Pragmatic trial, Primary care, Text messages, Wearables,
- 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
UNLABELLED: Despite individual recommendations on osteoporosis management in patients after hip fracture surgery, addressed by orthopedic surgeons to Czech general practitioners, the patients remained undiagnosed and untreated because of provider-level barriers to post-fracture secondary prevention. PURPOSE: The goal of the study was to assess whether an individual recommendation on osteoporosis treatment addressed to a hip fracture patient's GP would lead to better osteoporosis management. METHODS: Two groups of patients who suffered hip fractures and were treated at the Orthopedic Department were evaluated. In 111 patients, general recommendations on osteoporosis treatment and fracture prevention were provided in a discharge report addressed to the GP. In the second group, 96 patients were provided individually with a detailed written set of recommendations on osteoporosis examination, treatment, and fracture prevention, which was also provided in the discharge report. A questionnaire to assess the provided care was mailed to the patients 5.3 ± 1.2 months of discharge. Those patients who did not return the questionnaires were contacted by phone. RESULTS: The questionnaires were received from 44% and 49% of patients from the general and detailed recommendation groups, respectively. Along with the phone call, we were able to contact 78 (70.3%) and 68 (70.8%) patients from the general and detailed recommendation groups, respectively. GPs secured osteoporosis evaluation in 14.6% of the patients. Calcium supplementation and vitamin D supplementation were newly provided in 42.7 and 36.4% of the patients, respectively. Anti-resorptive therapy was newly provided in 8.3% of the patients. No significant differences between the groups were observed in osteoporosis evaluation, calcium and vitamin D supplementation, and anti-osteoporosis treatments. Out of 207 patients, further examination or treatment was requested by 45 patients (21.7%); 75 patients (36.2%) declared no interest in further care. CONCLUSION: Recommendations on osteoporosis management addressed to Czech GPs after surgical fracture management had little effect on treatment. As the anti-osteoporotic preparations can only be prescribed by specialists, the availability of necessary examinations and treatment is limited by the motivation of GPs. Consequently, the implementation of Fracture Liaison Services to help close the care gap may be limited in the absence of participation by Czech GPs.
- Klíčová slova
- Fracture Liaison Services, Hip fracture, Osteoporosis,
- MeSH
- fraktury kyčle prevence a kontrola chirurgie MeSH
- kooperační chování MeSH
- lidé středního věku MeSH
- lidé MeSH
- osteoporotické fraktury prevence a kontrola MeSH
- osteoporóza komplikace terapie MeSH
- pooperační období MeSH
- potravní doplňky statistika a číselné údaje MeSH
- praktické lékařství metody MeSH
- průzkumy a dotazníky MeSH
- sekundární prevence metody MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnotící studie MeSH
- Geografické názvy
- Česká republika MeSH