|

The PACT (Patient Activation Through Conversations) Study

RECRUITINGN/ASponsored by National Healthcare Group Polyclinics
Actively Recruiting
PhaseN/A
SponsorNational Healthcare Group Polyclinics
Started2024-04-22
Est. completion2025-03-31
Eligibility
Age21 Years – 64 Years
Healthy vol.Accepted

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

Age: 21 Years – 64 YearsHealthy volunteers accepted
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.

Conditions3

DiabetesDiabetes MellitusDiabetes Mellitus, Type 2

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.