App-based Diabetes Management and Community-based Interventions

Официальное название

EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention

Обзор

Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.

Вмешательства

• Поведенческое App-based diabetes management and community-based health coaching
  All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.

Первичные конечные точки

• HbA1c [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Physical activity as measured by number of steps [Срок оценки: 6 months]
• Physical activity as measured by moderate to vigorous active minutes [Срок оценки: 6 months]
• Physical activity as measured by GPAQ [Срок оценки: 6 months]
• Patient activation score as measured by patient activation measure [Срок оценки: 6 months]
• Medication adherence as measured by MARS-5 [Срок оценки: 6 months]
• Quality of life as measured by EQ-5D-5L [Срок оценки: 6 months]
• Healthcare cost as measured by cost of consultations, lab tests, medications, admission [Срок оценки: 6 months]
• Healthcare cost as measured by WPAI [Срок оценки: 6 months]
• Maintenance of the intervention effects on HbA1c [Срок оценки: 6 months]
• Maintenance of the intervention effects on blood pressure [Срок оценки: 6 months]
• Maintenance of the intervention effects on total cholesterol [Срок оценки: 6 months]
• Maintenance of the intervention effects on high-density lipoprotein (HDL) [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Aged 21 years and above
• Having been diagnosed with type 2 diabetes mellitus
• Having most recent HbA1c ≥ 6.5%
• Physically able to exercise
• Able to read, write, and converse in English
• Able to comply with study procedures

Критерии исключения

• Requiring assistance with basic activities of daily living (BADL)
• Have planned major operation or surgical procedure within 6 months from the time of recruitment
• Current pregnant or lactating

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 2 центра

• Singapore General Hospital — Singapore
• Singapore General Hospital — Singapore

Идентификаторы

NCT: NCT06688903 · 202409-00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗