The PACT (Patient Activation Through Conversations) Study

Recruiting now · Not applicable

Conditions studied: Diabetes Mellitus, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT06444074

Run by

National Healthcare Group Polyclinics

People needed

432

Starts

2024-04-22

Expected to finish

2028-04-22

Last updated by the study team

2024-06-13

Who can join

Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• NHGP Woodlands Polyclinic — Singapore, Singapore (enrolling)
• NHGP Geylang Polyclinic — Singapore, Singapore
• NHGP Ang Mo Kio Polyclinic — Singapore, Singapore

Full record on ClinicalTrials.gov

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