Outcomes-Based Health Program for Type 2 Diabetes

Официальное название

Outcomes-Based Health Program for Improving Care and Outcomes in Patients With Type 2 Diabetes: A Real-World Implementation Study in Primary Care

Обзор

Type 2 diabetes is a growing health concern worldwide, influenced by genetic factors, overweight, metabolic syndrome, and insufficient physical activity. Good treatment and glycemic control can reduce or delay diabetes-related complications, which account for a significant and increasing share of healthcare costs in Finland. Much of this cost growth is due to complications resulting from inadequate diabetes care. Secondary prevention programs can therefore provide both health and economic benefits. Lifestyle interventions are one way to improve type 2 diabetes care and reduce complications. This study aims to evaluate the impact of a digital lifestyle intervention combined with optimized care on treatment and outcomes among adults with type 2 diabetes at high risk for complications. The intervention includes access to the BitHabit "Small Actions" application, which supports healthy lifestyle changes, and for participants with a body mass index (BMI) over 30, the Onnikka weight management application. The study will be conducted in North Savo, Finland, using a case-control design. Approximately 120 participants will receive the intervention and 50-100 will serve as controls. All participants will have their care plans reviewed and updated according to the Finnish Current Care Guidelines for Type 2 Diabetes. Control group participants will receive standard care, while the intervention group will receive standard care plus the digital tools. The study also includes the validation of the PAID (Problem Areas in Diabetes) questionnaire for use in Finland and in the Finnish language. The study duration for each participant is 12 months. Data will be collected through physiological measurements, laboratory tests, questionnaires, and app usage logs. Measurements and questionnaires will be conducted at baseline and after 12 months. The analyses will describe the phenomenon, its prevalence, and associations between variables, as well as potential dependencies.

Вмешательства

• Другое BitHabit digital application for behavioral lifestyle changes
  BitHabit digital application for behavioral lifestyle changes
• Другое Onnikka weight management digital application
  Onnikka weight management digital application

Первичные конечные точки

• Change from baseline in weight at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in BMI at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in waist circumference at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in Body Roundness Index at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in HbA1c at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in serum lipid levels at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in smoking status at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in physical activity at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in dietary habits at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]
• Change from baseline in blood pressure at 12 months [Срок оценки: From enrollment to the end of follow-up at 12 months]

Критерии участия

Критерии включения

• Type 2 diabetes diagnosed
• At least one of the following:

• diagnosed coronary artery disease,
• diagnosed periferal artery disease,
• diagnosed heart failure,
• diagnosed diabetic renal disease (GFR <60 OR uACR ≥ 3 for at least three months),
• diagnosed diabetic retinopathy,
• previous stroke,
• diagnosed atrial fibrillation or atrial flutter,
• age ≥ 55 years and at least two of the following conditions:

• smoker
• uses antihypertensive medication or systolic blood pressure >140 mmHg or diastolic blood pressure > 80 mmHg,
• uses lipid lowering medication or LDL-cholesterol > 2.6 or
• BMI > 25

Критерии исключения

• eGFR < 30
• uACR > 200
• BMI > 50
• heart ejection fraction EF < 30
• active cancer or less than five years from cancer treatment at enrollment
• blindness in both eyes
• severe psychotic depression
• inability to utilize digital applications

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Финляндия · 1 центр

• Wellbeing services county of North Savo, Nursing and Physician Services — Kuopio

Идентификаторы

NCT: NCT07322757 · 5103906

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗