Self-management Intervention for People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial

NCT07792785 | Not Yet Recruiting

• 1 other identifier: Ref. 22231741
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized controlled trial aims to evaluate the feasibility and preliminary effects of a telephone-based self-management intervention for adults with cardiometabolic multimorbidity. Cardiometabolic multimorbidity refers to having two or more chronic cardiometabolic conditions, such as hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke. The intervention integrates motivational interviewing, self-affirmation, and problem-solving training to support participants in improving their motivation, confidence, and skills for chronic disease self-management and lifestyle behavior modification. Participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive two biweekly telephone consultation sessions. The control group will receive usual care according to government guidelines. All participants will complete assessments at baseline, immediately after the intervention, and 3 months after the intervention.

Conditions

Cardiometabolic Comorbidities

Keywords

cardiometabolic comorbidities; lifestyle modification; patient activation; motivational interviewing; problem-solving; self-affirmation

Outcome Measures

Primary Outcomes (3)

• Retention rate at 3 months

  Proportion of randomized participants who complete the 3-month primary assessment

  From randomization to the end of intervention at 3 months

• Intervention adherence rate

  Proportion of participants who attend all the scheduled intervention sessions

  From enrollment to the end of intervention

• Recruitment rate

  Proportion of eligible individuals who consent and are randomized.

  From the start of recruitment to completion of enrollment

Secondary Outcomes (7)

• Change in patient activation from baseline to 3 months

  From baseline to the end of intervention at 3 months

• Change in health behavior from baseline to 3 months

  From baseline to the end of intervention at 3 months

• Change in motivation for behavior change from baseline to 3 months

  From baseline to the end of intervention at 3 months

• Change in self-efficacy for managing chronic disease from baseline to 3 months

  From baseline to the end of intervention at 3 months

• Change in health-related quality of life from baseline to 3 months

  From baseline to the end of intervention at 3 months

Other Outcomes (1)

• Qualitative process evaluation of intervention feasibility and acceptability

  From enrollment to the end of intervention at 3 months

Study Arms (2)

MSP-MI

EXPERIMENTAL

The intervention will comprise two biweekly telephone consultations, conducted by well-trained RAs with expertise in social science, health psychology, or behavioral medicine. These consultations will utilize MI blended with behavioral change techniques, including self-affirmation and problem-solving training.

Behavioral: Motivational interviewing, self-affirmation and problem-solving

Usual care

PLACEBO COMPARATOR

The control group will receive usual care accordingly to government guidelines.

Other: Usual Care

Interventions

Motivational interviewing, self-affirmation and problem-solving BEHAVIORAL

The proposed study will use an MI-based intervention, blended and strengthened by self-affirmation and problem-solving techniques (MSP-SMI) to improve patient activation and lifestyle modification in patients with multimorbidity in HK. This integrated intervention is designed to tackle key behavioral change processes as posited in the IMB model and thus may have enhanced efficacy.

Also known as: motivational interviewing, self-affirmation, problem-solving, MSP-MI

MSP-MI

Usual Care OTHER

The control group will receive usual care accordingly to government guidelines.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 years
• having at least two chronic cardiometabolic diseases (i.e., hypertension, type 2 diabetes, hyperlipidemia, metabolic syndrome, coronary heart disease, or stroke) as confirmed by a doctor or the use of corresponding prescription medications/treatment
• having mobile phones
• mentally competent to understand the study.

You may not qualify if:

• current participation in similar projects or serious or life-threatening medical conditions (e.g., cancer, end-stage renal disease with dialysis, dementia) that would hinder study procedures.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Patient Participation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• rui she, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui She, PhD

CONTACT

+85227665693; sherryshe0319@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

CN (1)