The PACT (Patient Activation Through Conversations) Study
Recruiting · NCT06444074 · Interventional (participants receive a specific treatment) · Lead sponsor: National Healthcare Group Polyclinics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
3 locations listed.
- NHGP Geylang Polyclinic - Singapore, Singapore
- NHGP Ang Mo Kio Polyclinic - Singapore, Singapore
- NHGP Woodlands Polyclinic - Singapore, Singapore