A cluster randomized trial of a health coach-led patient activation program in type 2 diabetes in Singapore - a study protocol

Abstract

Background: Self-management of type 2 diabetes is the cornerstone of diabetes care. Health coaching, with its focus on developing intrinsic motivation, is a promising intervention for improving self-care behaviors and suboptimal glycemic levels. Studies evaluating the effectiveness of utilizing trained lay persons as health coaches in Asia are lacking. This study aims to assess the effectiveness of the Patient Activation through Conversations (PACT) program, a 3-month health coaching program, compared to usual care, in improving glycemic control among adults with type 2 diabetes. Methods/design: A pragmatic cluster-randomized controlled trial will be conducted, randomizing 18 Teamlets from 3 polyclinics (large publicly-funded primary care clinics) to PACT or Usual Care. A total of 432 participants, aged 21-64, with HbA1c ≥ 8.0%, will be recruited. The PACT program is a 3-month health coaching program led by a health coach (trained lay person), and involves review of a PACT report, assisted goal setting and support via telephone or messaging. A mixed-methods evaluation will be conducted. The primary outcome is change in Glycated Hemoglobin (HbA1c) levels, measured at 3, 6, 12 and 24 months. Secondary outcomes include blood pressure, Body Mass Index (BMI), Low Density Lipoprotein-Cholesterol (LDL-C), lifestyle behaviors, diabetes-related distress, self-efficacy, and health-related quality of life. Cost-effectiveness will be evaluated, and a qualitative study will be conducted at 3 months to better understand participants’ experiences of the PACT program. Discussion: Health coaching addresses gaps in traditional diabetes care through personalized support and behavioral modification, utilizing trained lay persons as health coaches. This study, the first randomized control trial of health coaching in type 2 diabetes in Singapore, aims to inform clinical practice and healthcare policy, with potential for broader applicability to other chronic diseases. Trial registration: Clinicaltrials.gov, NCT 06444074. Retrospectively registered on 11 June 2024.