NCT06444074Recruiting
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.
Source: ClinicalTrials.gov · Last updated 13 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 432 (estimated)
- First submitted
- 30 May 2024
- Start date
- 22 Apr 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- National Healthcare Group Polyclinics
- Diseases
- Type 2 diabetes
- NCT number
- NCT06444074
What you commit to
- Study type: Interventional
- Planned participants: 432
- From 22 Apr 2024 to the primary completion date, 31 Mar 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of acute coronary syndrome in the past 3 months
- History of stroke or transient ischaemic attacks in the past 3 months
- Cancer requiring treatment in the past 5 years.
- Patients who are enrolled in other current diabetes-related interventional studies
Lab values
- History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR \<30 mL/min/1.73m2 in the last 6 months)
Other
- 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
- Inability to provide written consent for the study protocol and able to commit to the study duration.
Who the study is looking for
- 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
Age in the registry: 21 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHGP Woodlands Polyclinic Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| NHGP Ang Mo Kio Polyclinic Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
| NHGP Geylang Polyclinic Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
Related publications
- A cluster randomized trial of a health coach-led patient activation program in type 2 diabetes in Singapore - a study protocol.BMC Prim Care · 2025 · PMID 41327015
This page is information, not medical advice. Discuss any trial with your doctor.