Health TrialsbyHealthPanel

The PACT (Patient Activation Through Conversations) Study

ConditionsDiabetes MellitusDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-64
SponsorNational Healthcare Group Polyclinics

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient Activation through Conversations (PACT) Program

    Behavioral

    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.

  • Usual Care

    Behavioral

    Routine Chronic Disease care

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: PACT ArmExperimental treatment 1 intervention
Group B: Usual CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Glycated Hemoglobin

Time frame
24 Months

Secondary outcomes

1

Blood Pressure

Systolic and Diastolic Blood Pressure

Time frame
24 months
2

BMI

Body Mass Index

Time frame
24 months
3

LDL-C

Low density Lipoprotein cholesterol

Time frame
24 months
4

eGFR

Estimated glomerular filtration rate

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Healthcare Group Polyclinics

Lead sponsor

National Healthcare Group, Singapore

Collaborator

Source ClinicalTrials.gov
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