Actively Recruiting
The PACT (Patient Activation Through Conversations) Study
Led by National Healthcare Group Polyclinics · Updated on 2024-06-13
432
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
National Healthcare Group Polyclinics
Lead Sponsor
N
National Healthcare Group, Singapore
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The PACT (Patient Activation Through Conversations) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Type 2 Diabetes Mellitus and enrolled in NHGP Teamlets
- Age between 21 to 64 years old
- HbA1c level above 8% in the past 6 months
You will not qualify if you...
- History of acute coronary syndrome in the last 3 months
- History of stroke or transient ischemic attacks in the last 3 months
- History of end stage organ failure (liver cirrhosis, cardiac failure, or eGFR <30 mL/min/1.73m2 in last 6 months)
- Cancer requiring treatment in the past 5 years
- Currently under active psychiatric follow-up
- Significant social issues requiring medical social worker follow-up in past 12 months
- Women who are pregnant or breastfeeding
- Participation in other diabetes-related interventional studies
- Unable to provide written consent or commit to study duration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
NHGP Geylang Polyclinic
Singapore, Singapore, 389707
Not Yet Recruiting
2
NHGP Ang Mo Kio Polyclinic
Singapore, Singapore, 569666
Not Yet Recruiting
3
NHGP Woodlands Polyclinic
Singapore, Singapore, 738579
Actively Recruiting
Research Team
J
Jun Hwee Benjamin Lee, MBBS
CONTACT
S
Sabrina Kay Wye Wong, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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