NCT06444074 The PACT (Patient Activation Through Conversations) Study
| NCT ID | NCT06444074 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Healthcare Group Polyclinics |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 432 participants |
| Start Date | 2024-04-22 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 432 participants in total. It began in 2024-04-22 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Sabrina Kay Wye Wong, MBBS
PRINCIPAL INVESTIGATOR
National Healthcare Group Polyclinics
Frequently Asked Questions
Who can join the NCT06444074 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 64 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06444074 currently recruiting?
Yes, NCT06444074 is actively recruiting participants. Contact the research team at benjamin_jh_lee@nhgp.com.sg for enrollment information.
Where is the NCT06444074 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT06444074 clinical trial?
NCT06444074 is sponsored by National Healthcare Group Polyclinics. The principal investigator is Sabrina Kay Wye Wong, MBBS at National Healthcare Group Polyclinics. The trial plans to enroll 432 participants.
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