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
- Accelerometry MeSH
- Exercise * MeSH
- Diabetes Mellitus, Type 2 * therapy psychology diagnosis MeSH
- Fitness Trackers MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Wearable Electronic Devices MeSH
- Pragmatic Clinical Trials as Topic MeSH
- General Practice * methods MeSH
- Prediabetic State * therapy psychology diagnosis MeSH
- Sedentary Behavior * MeSH
- Telemedicine * statistics & numerical data MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
Introduction: The COVID-19 pandemic disrupted global healthcare, including HIV care. eHealth emerged as an alternative to traditional in-person care. This study aimed to evaluate eHealth access among people living with HIV in Barcelona, Spain. Methods: A sequential explanatory mixed methods approach was used. Data were gathered through surveys (n = 82), semi-structured interviews, and a focus group to understand eHealth usage and perceptions. Results: 65% of survey respondents reported using eHealth services in their HIV unit at least once during the pandemic, while 52% reported never being offered these services, indicating a gap in availability and access. Participants identified convenience and timesaving as the main benefits of eHealth, particularly valuable during movement restrictions. Barriers such as perceived reduction in care quality, especially for those with language difficulties, were noted. While eHealth offers potential benefits, critical areas need addressing to ensure equitable access and high-quality care. Conclusion: Promoting eHealth services requires targeted improvements and understanding user preferences and needs. Tailoring eHealth solutions to diverse patient populations is crucial for successful implementation. As healthcare evolves post-pandemic, integrating eHealth to complement traditional care and address challenges faced by vulnerable populations, such as those living with HIV, is essential.
- Keywords
- eHealth,
- MeSH
- Data Analysis MeSH
- COVID-19 MeSH
- Health Services Accessibility organization & administration MeSH
- HIV * MeSH
- Humans MeSH
- Surveys and Questionnaires MeSH
- Telemedicine * classification statistics & numerical data MeSH
- Health Literacy methods MeSH
- Check Tag
- Humans MeSH
- Publication type
- Clinical Study MeSH
- Geographicals
- Spain MeSH
Diabetes mellitus (DM) je chronické, postupujúce, celoživotné ochorenie, spojené s pravidelnými vyšetreniami u lekára. Monitoring meraní patrí medzi kľúčové faktory v manažmente ochorenia a je aj ukazovateľom adherencie a kompliancie diabetika. Najvyššia ochota k spolupráci na liečbe zo strany pacienta je na začiatku ochorenia a v prvých niekoľkých mesiacoch, potom dlhodobo pozvoľne slabne. V štúdii sme v podmienkach bežnej medicínskej praxe diabetologickej ambulancie vyhodnocovali údaje u 211 novodiagnostikovaných diabetikov 2. typu po dobu 11 mesiacov. Okrem rutinnej praxe osobných návštev na ambulancii sme aktívne využili možnosti telemedicíny. Pacienti dostali pri prvej návšteve telemedicínsky kit, ktorý obsahoval glukomer, váhu, tlakomer, EKG, spirometer, teplomer a oxymeter. Úroveň metabolickej kompenzácie sme verifikovali vyhodnotením hladín glykovaného hemoglobínu. Zavedenie telemedicíny umožňuje sledovanie kompliancie a adherencie pri liečbe DM. Narastajúci počet diabetikov a frekvencia vyšetrení vyvoláva tlak na zdravotný systém. V manažmente pacienta s DM sú potrebné nástroje na objektivizáciu na trvalú motiváciu pacientov. Telemedicína prispieva k lepšej kompliancii, adherencii a metabolickej kompenzácii a znižuje potrebu frekvencie osobných návštev pacienta.
Diabetes mellitus (DM) is a chronic, progressive, lifelong disease associated with regular visits at doctor. Monitoring measurements is one of the key factors in disease management and it is also an indicator of diabetic adherence and compliance of the patient. Patient is mostly willing to cooperate in the treatment at the beginning of the disease and in the first few months, after that it gradually weakens over the long term. In the study, we evaluated the data of 211 newly diagnosed patients with type 2 diabetes for a period of 11 months. In addition to the routine practice of personal visits of the doctor, we actively used the possibilities of telemedicine. During the first visit, patients received a telemedicine kit that includes glucometer, scale, blood pressure monitor, ECG and oximeter. The metabolic compensation was verified by evaluating glycated hemoglobin. By establishing telemedicine it enabled monitoring of compliance and adherence in the treatment of DM. The growing number of diabetics and the frequency of examinations puts pressure on the health system. In the management of patients with DM, tools for objectification are needed to continuously motivate patients. Telemedicine contributes to better compliance, adherence, metabolic compensation and reduces the need for frequent personal patient visits.
- MeSH
- Treatment Adherence and Compliance MeSH
- Diabetes Mellitus, Type 2 * prevention & control therapy MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Blood Pressure Determination methods instrumentation statistics & numerical data MeSH
- Blood Glucose Self-Monitoring methods instrumentation statistics & numerical data MeSH
- Aged MeSH
- Telemedicine * methods instrumentation statistics & numerical data MeSH
- Heart Rate Determination instrumentation statistics & numerical data MeSH
- Body Weight Changes MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Clinical Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- MeSH
- Biomedical Technology methods instrumentation statistics & numerical data MeSH
- Diabetes Mellitus * prevention & control therapy MeSH
- Glycated Hemoglobin analysis MeSH
- Insulin, Regular, Human administration & dosage MeSH
- Insulin Infusion Systems statistics & numerical data MeSH
- Communication MeSH
- Blood Glucose analysis MeSH
- Humans MeSH
- Statistics as Topic MeSH
- Telemedicine * methods organization & administration instrumentation statistics & numerical data MeSH
- Patient Education as Topic MeSH
- Check Tag
- Humans MeSH
- Publication type
- Research Support, Non-U.S. Gov't MeSH
- MeSH
- Diabetes Mellitus * prevention & control therapy MeSH
- Humans MeSH
- Routinely Collected Health Data MeSH
- Blood Glucose Self-Monitoring MeSH
- Telemedicine * methods statistics & numerical data trends MeSH
- Internal Medicine methods trends MeSH
- Check Tag
- Humans MeSH
- Publication type
- Newspaper Article MeSH
Psychotherapists around the world are facing an unprecedented situation with the outbreak of the novel coronavirus disease (COVID-19). To combat the rapid spread of the virus, direct contact with others has to be avoided when possible. Therefore, remote psychotherapy provides a valuable option to continue mental health care during the COVID-19 pandemic. The present study investigated the fear of psychotherapists to become infected with COVID-19 during psychotherapy in personal contact and assessed how the provision of psychotherapy changed due to the COVID-19 situation and whether there were differences with regard to country and gender. Psychotherapists from three European countries: Czech Republic (CZ, n = 112), Germany (DE, n = 130) and Slovakia (SK, n = 96), with on average 77.8% female participants, completed an online survey. Participants rated the fear of COVID-19 infection during face-to-face psychotherapy and reported the number of patients treated on average per week (in personal contact, via telephone, via internet) during the COVID-19 situation as well as (retrospectively) in the months before. Fear of COVID-19 infection was highest in SK and lowest in DE (p < 0.001) and was higher in female compared to male psychotherapists (p = 0.021). In all countries, the number of patients treated on average per week in personal contact decreased (p < 0.001) and remote psychotherapies increased (p < 0.001), with more patients being treated via internet than via telephone during the COVID-19 situation (p < 0.001). Furthermore, female psychotherapists treated less patients in personal contact (p = 0.036), while they treated more patients via telephone than their male colleagues (p = 0.015). Overall, the total number of patients treated did not differ during COVID-19 from the months before (p = 0.133) and psychotherapy in personal contact remained the most common treatment modality. Results imply that the supply of mental health care could be maintained during COVID-19 and that changes in the provision of psychotherapy vary among countries and gender.
- MeSH
- Betacoronavirus MeSH
- Coronavirus MeSH
- Adult MeSH
- Coronavirus Infections psychology MeSH
- Middle Aged MeSH
- Humans MeSH
- Pandemics MeSH
- Surveys and Questionnaires MeSH
- Psychotherapy methods statistics & numerical data MeSH
- Fear MeSH
- Telemedicine statistics & numerical data MeSH
- Pneumonia, Viral psychology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Czech Republic MeSH
- Germany MeSH
- Slovakia MeSH
BACKGROUND: It is unclear whether asthma may affect susceptibility or severity of coronavirus disease 2019 (COVID-19) in children and how pediatric asthma services worldwide have responded to the pandemic. OBJECTIVE: To describe the impact of the COVID-19 pandemic on pediatric asthma services and on disease burden in their patients. METHODS: An online survey was sent to members of the Pediatric Asthma in Real Life think tank and the World Allergy Organization Pediatric Asthma Committee. It included questions on service provision, disease burden, and the clinical course of confirmed cases of COVID-19 infection among children with asthma. RESULTS: Ninety-one respondents, caring for an estimated population of more than 133,000 children with asthma, completed the survey. COVID-19 significantly impacted pediatric asthma services: 39% ceased physical appointments, 47% stopped accepting new patients, and 75% limited patients' visits. Consultations were almost halved to a median of 20 (interquartile range, 10-25) patients per week. Virtual clinics and helplines were launched in most centers. Better than expected disease control was reported in 20% (10%-40%) of patients, whereas control was negatively affected in only 10% (7.5%-12.5%). Adherence also appeared to increase. Only 15 confirmed cases of COVID-19 were reported among the population; the estimated incidence is not apparently different from the reports of general pediatric cohorts. CONCLUSIONS: Children with asthma do not appear to be disproportionately affected by COVID-19. Outcomes may even have improved, possibly through increased adherence and/or reduced exposures. Clinical services have rapidly responded to the pandemic by limiting and replacing physical appointments with virtual encounters.
- MeSH
- Medication Adherence MeSH
- Betacoronavirus MeSH
- Asthma epidemiology physiopathology therapy MeSH
- Time Factors MeSH
- Global Health MeSH
- Child MeSH
- Coronavirus Infections epidemiology MeSH
- Humans MeSH
- Pandemics MeSH
- Appointments and Schedules MeSH
- Severity of Illness Index MeSH
- Telemedicine organization & administration statistics & numerical data MeSH
- Pneumonia, Viral epidemiology MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
