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

A Multi-faceted Self-management Intervention for Improving Patient Activation and Lifestyle Behavior Modification Among People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiometabolic Comorbidities
• Intervention / Treatment: Behavioral: Motivational interviewing, self-affirmation and problem-solving; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rui She, PhD; Phone Number: +85227665693; Email: sherryshe0319@link.cuhk.edu.hk

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • The Hong Kong Polytechnic University
      • Contact: Rui She, PhD; Phone Number: +852 2766 5693; Email: sherryshe0319@link.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSP-MI; 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; 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.; Other Names: motivational interviewing; problem-solving; self-affirmation; MSP-MI
Placebo Comparator: Usual care; The control group will receive usual care accordingly to government guidelines.	Other: Usual Care; The control group will receive usual care accordingly to government guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mental health from baseline to 3 months	Mental health will be assessed using the Patient Health Questionnaire-4, with higher scores indicating greater mental distress.	From baseline to the end of intervention at 3 months
Change in patient activation from baseline to 3 months	Patient activation will be assessed using the 13-item Patient Activation Measure. The PAM-13 consists of 13 items on a 4-point Likert scale. Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate greater patient activation.	From baseline to the end of intervention at 3 months
Change in health behavior from baseline to 3 months	Health behavior will be assessed using the 12-item Simple Lifestyle Indicator Questionnaire. The SLIQ has 5 components: diet (3 questions), activity (3 questions), alcohol consumption (3 questions), smoking (2 questions), and stress (1 question). For each component, a raw score and a category score can be calculated. To provide equal weighting for each component, the overall SLIQ score is based on the 5 category scores. Each component has a category score of 0, 1, or 2, so overall SLIQ scores can range from 0 to 10. The higher the score, the healthier the lifestyle.	From baseline to the end of intervention at 3 months
Change in motivation for behavior change from baseline to 3 months	Motivation for behavior change will be assessed using the Contemplation Ladder. It displays a picture of a ladder numbered from 0 to 10. Higher scores indicate greater readiness or motivation to change health behavior.	From baseline to the end of intervention at 3 months
Change in self-efficacy for managing chronic disease from baseline to 3 months	Self-efficacy for managing chronic disease will be assessed using the six-item Self-Efficacy for Managing Chronic Disease Scale. It has a 10-point Likert-type scoring system (1 = Not at all confident, 10 = Totally confident). The total scores range from 6 to 60, with higher scores indicating greater self-efficacy.	From baseline to the end of intervention at 3 months
Change in health-related quality of life from baseline to 3 months	Health-related quality of life will be assessed using the 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-5L), which consists of 2 parts: the EQ-5D and EQ visual analog scale. The EQ-5D-5L utility index score will be calculated using the value set of the appropriate population (typically range from less than 0 up to 1 for full health), with higher scores indicating better health-related quality of life.	From baseline to the end of intervention at 3 months
Change in self-rated health status from baseline to 3 months	Self-rated health status will be assessed using the EQ visual analog scale of 5 levels of severity for each of the 5 dimensions from the EuroQoL Group (EQ-5D-3L). Scores range from 0 to 100, with higher scores indicating better self-rated health.	From baseline to the end of intervention at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative process evaluation of intervention feasibility and acceptability	Approximately 20-30 participants will be invited to participate in semi-structured interviews, or until thematic saturation is reached. Interviews will explore participants' experiences, perceived feasibility, acceptability, barriers, and facilitators related to the intervention. Qualitative data will be audio-recorded, transcribed, and analyzed thematically. Findings will be reported narratively and will not be aggregated into a single quantitative score.	From enrollment to the end of intervention at 3 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: rui she, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: patient activation; motivational interviewing; lifestyle modification; problem-solving; self-affirmation; cardiometabolic comorbidities
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Patient Participation; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: Ref. 22231741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: he data sharing plan has not yet been finalized and will be determined in accordance with participant consent, institutional policies, and ethics approval requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No