An interventional study of Motivational interviewing, self-affirmation and problem-solving and Usual Care in Cardiometabolic Comorbidities, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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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.
409 studies on the registry are indexed under Patient Participation; 100 are open to participants now.
This study's planned enrollment of 72 is below the median of 128 across 322 interventional studies indexed under Patient Participation.
Browse Patient Participation studies →The Hong Kong Polytechnic University is the lead sponsor of 681 studies on the registry; 259 are open to participants now.
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Exclusion Criteria:
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 control group will receive usual care accordingly to government guidelines.
Other: Usual Care
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
The control group will receive usual care accordingly to government guidelines.
Retention rate at 3 months
Proportion of randomized participants who complete the 3-month primary assessment
Time frame: From randomization to the end of intervention at 3 months
Intervention adherence rate
Proportion of participants who attend all the scheduled intervention sessions
Time frame: From enrollment to the end of intervention
Recruitment rate
Proportion of eligible individuals who consent and are randomized.
Time frame: From the start of recruitment to completion of enrollment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to the end of intervention at 3 months
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.
Time frame: From baseline to the end of intervention at 3 months
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.
Time frame: From enrollment to the end of intervention at 3 months
Plan to share: Undecided — he data sharing plan has not yet been finalized and will be determined in accordance with participant consent, institutional policies, and ethics approval requirements.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Oct 2027, 14 months later.
Of 219 non-industry interventional studies with no phase under Patient Participation, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 14 months is below that.
Counting every sponsor, half of 226 studies reached it within 20 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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