The PACT (Patient Activation Through Conversations) Study

NCT06444074 | Recruiting DMC

• 1 other identifier: 2023/00667
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Health Coaching; Endocrinology; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Glycated Hemoglobin

  24 Months

Secondary Outcomes (16)

• Blood Pressure

  24 months

• BMI

  24 months

• LDL-C

  24 months

• eGFR

  24 months

• uACR

  24 months

Study Arms (2)

PACT Arm

EXPERIMENTAL

Participants in the intervention arm will undergo the PACT Program, which is a 3-month long health coaching program.

Behavioral: Patient Activation through Conversations (PACT) Program

Usual Care

PLACEBO COMPARATOR

Patients in the Usual Care Arm will undergo routine follow-up for their Diabetes Mellitus. In NHGP, this involves Teamlet care, where patients are taken care of by a team comprising of Family Physicians, a Care Manager (a nurse trained in chronic disease management), and a Care Coordinator, and are seen typically every three to six months for monitoring of their diabetic control.

Behavioral: Usual Care

Interventions

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.

PACT Arm

Usual Care BEHAVIORAL

Routine Chronic Disease care

Usual Care

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Healthcare Group Polyclinics: lead
• National Healthcare Group, Singapore: collaborator

Study Sites (3)

NHGP Geylang Polyclinic

Singapore, 389707, Singapore

NOT YET RECRUITING

NHGP Ang Mo Kio Polyclinic

Singapore, 569666, Singapore

NOT YET RECRUITING

NHGP Woodlands Polyclinic

Singapore, 738579, Singapore

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sabrina Kay Wye Wong, MBBS

  National Healthcare Group Polyclinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Hwee Benjamin Lee, MBBS

CONTACT

+6563553000; benjamin_jh_lee@nhgp.com.sg

Sabrina Kay Wye Wong, MBBS

CONTACT

+6563553000; sabrina_kw_wong@nhgp.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study design is a pragmatic cluster randomised controlled trial. Each cluster consists of a Teamlet in a National Health Group Polyclinic (NHGP), consisting of a regular group of Family Physicians, a Care Manager, and a Care Coordinator, that provide chronic care for a regular group of about 5000 patients. Teamlets in each polyclinic will be randomised to either the PACT Program condition or Usual Care condition. Patients who belong to Teamlets that are randomised to the PACT Program condition will be recruited for participation in the PACT Program, and patients who belong to Teamlets that are randomised to the Usual Care condition will be recruited and provided with routine care.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: April 22, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): April 22, 2028
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)