Cardiometabolic ComorbiditiesNCT07792785
Self-management Intervention for People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial
A study testing Motivational interviewing, self-affirmation and problem-solving in people with Cardiometabolic Comorbidities, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiometabolic Comorbidities
- What is being tested?
- Motivational interviewing, self-affirmation and problem-solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Rui She, PhD, +852 2766 5693, sherryshe0319@link.cuhk.edu.hk
About this study
Official 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
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
- Being tested
- Motivational interviewing, self-affirmation and problem-solving, Usual Care
- Keywords
- cardiometabolic comorbidities, lifestyle modification, patient activation, motivational interviewing, problem-solving, self-affirmation
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing, self-affirmation and problem-solvingBehavioural
Also called motivational interviewing, self-affirmation, problem-solving, MSP-MI
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.
Usual CareOther
The control group will receive usual care accordingly to government guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational interviewing, self-affirmation and problem-solving |
| Usual care | Placebo comparator | The control group will receive usual care accordingly to government guidelines. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate at 3 months
Proportion of randomized participants who complete the 3-month primary assessment
Measured: From randomization to the end of intervention at 3 months
Intervention adherence rate
Proportion of participants who attend all the scheduled intervention sessions
Measured: From enrollment to the end of intervention
Recruitment rate
Proportion of eligible individuals who consent and are randomized.
Measured: From the start of recruitment to completion of enrollment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of intervention at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic ComorbiditiesStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui She, The Hong Kong Polytechnic University
- Investigators
- rui she, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792785
- Sponsor's protocol ID
- Ref. 22231741
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07792785
- Acronym / sponsor ID
- Ref. 22231741
- Conditions
- Cardiometabolic Comorbidities
- Keywords
- cardiometabolic comorbidities, lifestyle modification, patient activation, motivational interviewing, problem-solving, self-affirmation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSP-MI | Experimental | Behavioral: Motivational interviewing, self-affirmation and problem-solvingThe 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. |
| Usual care | Placebo comparator | Other: Usual CareThe control group will receive usual care accordingly to government guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing, self-affirmation and problem-solvingAlso: motivational interviewing, self-affirmation, problem-solving, MSP-MIThe 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. | Behavioural | MSP-MI |
| Usual CareThe control group will receive usual care accordingly to government guidelines. | Other | Usual care |
Primary outcome
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
Intervention adherence rate
Time frame: From enrollment to the end of intervention
Proportion of participants who attend all the scheduled intervention sessions
Recruitment rate
Time frame: From the start of recruitment to completion of enrollment
Proportion of eligible individuals who consent and are randomized.
7 secondary outcomes
Change in patient activation from baseline to 3 months
Time frame: From baseline to the end of intervention at 3 months
Change in health behavior from baseline to 3 months
Time frame: From baseline to the end of intervention at 3 months
Change in motivation for behavior change from baseline to 3 months
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
Time frame: From baseline to the end of intervention at 3 months
Change in health-related quality of life from baseline to 3 months
Time frame: From baseline to the end of intervention at 3 months
Change in self-rated health status from baseline to 3 months
Time frame: From baseline to the end of intervention at 3 months
Change in mental health from baseline to 3 months
Time frame: From baseline to the end of intervention at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
rui she, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing, self-affirmation and problem-solving in people with Cardiometabolic Comorbidities, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui She, PhD (+85227665693, sherryshe0319@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate at 3 months (time frame: From randomization to the end of intervention at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.