RecruitingNot ApplicableNCT06444074

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.

Sponsor

National Healthcare Group Polyclinics

Enrollment

432 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2

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

Min Age: 21 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study, called the PACT (Patient Activation Through Conversations) Study, tests whether having guided conversations with healthcare providers helps people with poorly controlled type 2 diabetes become more active in managing their own health. Participants are adults with diabetes whose blood sugar levels remain high (HbA1c above 8%) despite being in care. **You may be eligible if...** - You have type 2 diabetes and are enrolled in a Teamlets program at NHGP (Singapore) - You are between 21 and 64 years old - Your HbA1c has been above 8% in the last 6 months **You may NOT be eligible if...** - You had a heart attack or stroke in the last 3 months - You have end-stage organ failure (severe liver, heart, or kidney disease) - You have been treated for cancer in the past 5 years - You are currently under active psychiatric care - You are pregnant or breastfeeding - You are enrolled in another diabetes study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPatient Activation through Conversations (PACT) Program

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.

BEHAVIORALUsual Care

Routine Chronic Disease care