About this trial
The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes. The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention (PACT program) led by Care Coaches (trained lay persons), in adult participants with sub-optimally controlled Diabetes Mellitus, as compared to participants undergoing routine care for diabetes (Usual Care).
The primary outcome of interest is change in Glycated Haemoglobin (HbA1c) levels over 3 months, 6 months and 12 months. Secondary outcomes include changes in blood pressure, low-density lipoprotein-cholesterol (LDL-C) levels, body mass index (BMI), self-reported diabetes self-care behaviours, self-efficacy, health-related quality of life, and diabetes-related distress, over 3, 6 and 12 months.
Participants in the Intervention arm will undergo the PACT Program, which is a 3-month long health coaching program led by a care coach. Participants review their motivators, health parameters, self-care behaviours, and set goals for improving their diabetes using a PACT report. Subsequently, they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration, and will return to routine care after 3 months. Participants in the Usual Care arm will have routine care of their diabetes treatment.
Eligibility criteria
Qualifiers
Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
Age between 21 to 64 years old
HbA1c level of more than 8% in the last 6 months
Disqualifiers
History of acute coronary syndrome in the past 3 months
History of stroke or transient ischaemic attacks in the past 3 months
History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR <30 mL/min/1.73m2 in the last 6 months)
Cancer requiring treatment in the past 5 years.
Trial design
Treatments tested in this trial
- Patient Activation through Conversations (PACT) Program
- Usual Care
Treatment groups
Sponsors and collaborators
National Healthcare Group Polyclinics
Lead sponsor
National Healthcare Group, Singapore
Collaborator