Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM)

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Multimorbidity; Cardiometabolic Diseases

Treatments: Behavioral: HcELP_CMM; Behavioral: Usual care-maintain daily lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT07158697

UW 25-383

Details and patient eligibility

About

The goal of this study is to:

1. assess the feasibility of the health chat for empowerment-based lifestyle planning for cardiometabolic multimorbidity (HcELP_CMM);
2. examine the immediate effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, health-related quality of life (HRQoL), psychological well-being, and physical function;
3. examine the long-term effects of the HcELP_CMM program on lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM.

The main questions it aims to answer are:

1. If the HcELP_CMM program is feasible?
2. If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the short-term？
3. If the HcELP_CMM program has the potential to improve the lifestyle behaviors, cardiometabolic indicators, symptom burden, HRQoL, psychological well-being, and physical function in patients with CMM compared to the usual care group in the long-term？

Full description

This study has two parts. Part 1 is a sequential mixed-method pilot study consisted of a single-blind, parallel-group, two-arm randomized controlled trial followed by a qualitative descriptive study. Part 2 is a full single-blind, parallel-group, two-arm randomized controlled trial study. In these two parts, participants with CMM will be randomly assigned to either an intervention group to receive the HcELP_CMM intervention or a control group to receive the usual care in a 1:1 ratio.

For part 1, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1: It involves an individualized face-to-face meeting conducted by the researcher in a private meeting room at the community health care centers (CHCCs) within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) assessing symptom burden and lifestyle behaviors; 2) generating and analyzing a symptom burden and lifestyle report; 3) engaging in empowerment-based therapeutic person-centered health communication; and 4) making a behavior commitment. Phase 2 will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) integrating healthy behaviors into a long-term lifestyle; and 2) sustaining healthy lifestyle behaviors. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors, fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. The control group will continue with their normal daily lifestyle. WeChat-based follow-ups will be conducted weekly during the first 4 weeks and biweekly in the subsequent 8 weeks, with each follow-up lasting 20 minutes. Follow-up communications will include: general well-being assessments; disease management monitoring; and addressing disease-related inquiries.Outcome data collection will occur in 1 week after the completion of the intervention through face-to-face interviews at the CHCCs, lasting about 30 minutes. Additionally, some participants in the intervention group will undergo semi-structured interviews via synchronized online video through the WeChat platform in1 week after the intervention concludes, lasting 1 hour. The interview will be audio recorded. Outcome data collection will occur in 1 week after the completion of the intervention through face-to-face interviews at the CHCCs, lasting about 30 minutes.

For part 2, the intervention group will participate in the 12-week HcELP_CMM project. The intervention consists of two phases. Phase 1: It involves an individualized face-to-face meeting conducted by the researcher in a private meeting room at the CHCCs within one week after random allocation, lasting about 1 hour. This phase includes four core steps: 1) assessing symptom burden and lifestyle behaviors; 2) generating and analyzing a symptom burden and lifestyle report; 3) engaging in empowerment-based therapeutic person-centered health communication; and 4) making a behavior commitment. Phase 2 will be delivered individually through the WeChat platform using the official account, chat function, and synchronized online video between weeks 2 and 12. It includes two modules:1) integrating healthy behaviors into a long-term lifestyle; and 2) sustaining healthy lifestyle behaviors. In Module 1, participants will implement action plans weekly, and a source hub of empowerment videos will be provided to promote the implementation of action plan. Additionally, participants will self-evaluate lifestyle behaviors and fill out and upload the logbook of self-assessment lifestyle behavior weekly. In Module 2, participants will self-monitor bio-feedback parameters, fill out and upload the logbook of self-monitoring biofeedback parameters weekly. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. The control group will continue with their normal daily lifestyle. WeChat-based follow-ups will be conducted weekly during the first 4 weeks and biweekly in the subsequent 8 weeks, with each follow-up lasting 20 minutes. Follow-up communications will include: general well-being assessments; disease management monitoring; and addressing disease-related inquiries. Besides, all participants in the intervention and control groups will undergo a 2-month follow-up after the intervention. During the follow-up period, all participants will maintain their daily lifestyle at home and obtained WeChat-based follow-up bi-weekly. Followup communications include: general well-being assessments; disease management monitoring; and addressing disease related inquiries. Outcome data collection will occur in 1 week after the completion of the intervention and follow-up through face-to-face interviews at the CHCCs, lasting about 30 minutes.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 years or above；
2. Diagnosed with cardiometabolic multimorbidity (CMM) by doctors, which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, primary type 2 diabetes, stroke, and heart diseases (eg. ischemic heart disease, arrhythmia, heart valve diseases, and other heart diseases);
3. Possessed a digital device installed with WeChat, as well as with an internet connection.

Exclusion criteria

1. Contraindications to exercise according to American College of Sports Medicine (ACSM), such as severe musculoskeletal disorders, severe cardiovascular diseases, or spinal nerve injury;
2. Diagnosis of psychiatric disease;
3. Has impaired cognitive function as indicated by an Abbreviated Mental Test Score (AMTS) ≤6;
4. Has impaired sensory or communication function which hider them participation in this program, such as hearing loss, vision loss, and unable to speak Mandarin;
5. Unable to sign the informed consent form.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups, including a placebo group

HcELP_CMM

Experimental group

Description:

Participants in the arm will attend a 12-week HcELP\_CMM program. This program is a hybrid intervention involving two phases: 1) an initial individualized, face-to-face meeting to collaboratively set goals and develop action plan (week 1); 2) an ongoing, personalized online support delivered by WeChat platform utilizing the official account, chat function, and synchronized online videos to integrate and sustain healthy lifestyle (weekly, week 2-12). Phase 1 covers 4 core steps: 1) assess symptom burden and lifestyle behaviors; 2) generate and analysis symptom burden and lifestyle report; 3) empowerment-based therapeutic person-centered health communication; and 4) behavior commitment. Phase 2 covers two modules: 1) integrate healthy behaviors to long-term lifestyle, and 2) sustain healthy lifestyle behaviors.

Treatment:

Behavioral: HcELP_CMM

Usual care-maintain daily lifestyle

Placebo Comparator group

Description:

Participants in the arm will continue with their normal daily lifestyle. WeChat-based follow-up will be performed weekly in the first 4 weeks and bi-weekly in the next 8 weeks. Each follow-up will last for 20 minutes. Follow-up communications will include: (1) general well-being assessments using brief, non-intrusive inquiries (e.g., "How have participants felt overall in the past week/two weeks?"); (2) disease management monitoring through standardized question tracking significant changes in their underlying diseases, intentionally avoiding exploration of intervention-targeted lifestyle behaviors (e.g., "Have participants experienced notable changes in their health status or disease management approach since last contact?"); and (3) addressing disease-related inquiries. For any questions inquired by participants in the control group, general advice will be given for ethical consideration.

Treatment:

Behavioral: Usual care-maintain daily lifestyle