Cardiometabolic Comorbidities
Conditions
Keywords
cardiometabolic comorbidities, lifestyle modification, patient activation, motivational interviewing, problem-solving, self-affirmation
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.
Interventions
BEHAVIORALMotivational 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.
OTHERUsual Care
The control group will receive usual care accordingly to government guidelines.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention adherence rate | From enrollment to the end of intervention | Proportion of participants who attend all the scheduled intervention sessions |
| Recruitment rate | From the start of recruitment to completion of enrollment | Proportion of eligible individuals who consent and are randomized. |
| Retention rate at 3 months | From randomization to the end of intervention at 3 months | Proportion of randomized participants who complete the 3-month primary assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient activation from baseline to 3 months | From baseline to the end of intervention at 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. |
| Change in health behavior from baseline to 3 months | From baseline to the end of intervention at 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. |
| Change in motivation for behavior change from baseline to 3 months | From baseline to the end of intervention at 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. |
| Change in self-efficacy for managing chronic disease from baseline to 3 months | 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. 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. |
| Change in health-related quality of life from baseline to 3 months | From baseline to the end of intervention at 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. |
| Change in self-rated health status from baseline to 3 months | From baseline to the end of intervention at 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. |
| Change in mental health from baseline to 3 months | 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. |
Countries
China
Contacts
CONTACTRui She, PhD
PRINCIPAL_INVESTIGATORrui she, PhD
The Hong Kong Polytechnic University
Outcome results
None listed