The PACT (Patient Activation Through Conversations) Study
The PACT (Patient Activation Through Conversations) Study - A Cluster Randomised Trial of a Health Coach-led Patient Activation Program in Type 2 Diabetes.
National Healthcare Group Polyclinics
432 participants
Apr 22, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria9
- 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.
- Active psychiatrist follow up
- Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
- Women who are pregnant or breastfeeding
- Patients who are enrolled in other current diabetes-related interventional studies
- Inability to provide written consent for the study protocol and able to commit to the study duration.
Interventions
Participants in the intervention arm will undergo a 3-month long health coaching program where a care coach will review a participant's health parameters and current self-care behaviours, identify health motivators and set goals for improving their diabetes, as well as fortnightly support through text or phone call.
Routine Chronic Disease care
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06444074