Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07792785

Self-management Intervention for 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cardiometabolic Comorbidities Behavior Health Behavior Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: motivational interviewing, self-affirmation, problem-solving, MSP-MI

Usual Care

Other

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

Primary outcomes

  1. Retention rate at 3 months

    Time frame: From randomization to the end of intervention at 3 months

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

  2. Intervention adherence rate

    Time frame: From enrollment to the end of intervention

    Proportion of participants who attend all the scheduled intervention sessions

  3. Recruitment rate

    Time frame: From the start of recruitment to completion of enrollment

    Proportion of eligible individuals who consent and are randomized.

Secondary outcomes

  1. Change in patient activation from baseline to 3 months

    Time frame: From baseline to the end of intervention at 3 months

    Patient activation will be assessed using the 13-item Patient Activation Measure. The total activation score will be calculated according to the scoring manual, with higher scores indicating greater patient activation.

  2. Change in health behavior from baseline to 3 months

    Time frame: From baseline to the end of intervention at 3 months

    Health behavior will be assessed using the 12-item Simple Lifestyle Indicator Questionnaire. The total score will be calculated according to the scoring instructions, with higher scores indicating healthier lifestyle behaviors.

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

    Time frame: From baseline to the end of intervention at 3 months

    Motivation for behavior change will be assessed using the Contemplation Ladder. Higher scores indicate greater readiness or motivation to change health behavior.

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

    Time frame: From baseline to the end of intervention at 3 months

    Self-efficacy for managing chronic disease will be assessed using the six-item Self-Efficacy for Managing Chronic Disease Scale. The total or mean score will be calculated according to the scoring instructions, with higher scores indicating greater self-efficacy.

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

    Time frame: From baseline to the end of intervention at 3 months

    Health-related quality of life will be assessed using the EQ-5D-5L. The EQ-5D-5L utility index score will be calculated using the appropriate value set, with higher scores indicating better health-related quality of life.

  6. Change in self-rated health status from baseline to 3 months

    Time frame: From baseline to the end of intervention at 3 months

    Self-rated health status will be assessed using the EQ-5D-5L visual analogue scale. Scores range from 0 to 100, with higher scores indicating better self-rated health.

  7. Change in mental health from baseline to 3 months

    Time frame: From baseline to the end of intervention at 3 months

    Mental health will be assessed using the Patient Health Questionnaire-4, with higher scores indicating greater mental distress.

Other outcomes

  1. Qualitative process evaluation of intervention feasibility and acceptability

    Time frame: From enrollment to the end of intervention at 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rui She, PhD

CONTACT

[email protected]

+85227665693

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.