Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM) Program: a Randomized Controlled Trial Study

The goal of this study is to:

1. assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP_CMM);
2. examine the short-term 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 in patients with CMM;
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 and acceptable?
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？

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 involves an individualized face-to-face goal-oriented health counseling 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) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which 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) lifestyle change for better; and 2) effective lifestyle maintenance. 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. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. 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 involves an individualized face-to-face goal-oriented health counseling 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) risk diagnostics by assessing symptom burden, lifestyle behaviors, and past experience of lifestyle modefication; 2) risk communication by generating and analyzing a symptom-lifestyle report; 3) goal setting by conducting a brief health education based on lifestyle behaviors guidelines for CMM and developing personalized goals and detailed action plan, and measurable bio-feedback parameters; and 4) strengthen commitment to lifestyle change by making a behavior commitment. Phase 2 is WeChat-based enhanced healthy lifestyle empowerment, which 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) lifestyle change for better; and 2) effective lifestyle maintenance. 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. Beside, a small Wechat group contained 8-10 participants will be created to facilitate communication and mutual support among participants. Furthermore, they will receive bi-weekly health counseling through synchronized online videos on the WeChat platform, with each session lasting about 20 minutes. Participants were then encouraged to integrate the discussed coping strategies into their daily routines.The control group will receive usual care provided by the CHCCs, which included general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention. 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.

Inclusion Criteria:

1. Adults aged 18 years or above；
2. Diagnosed with cardiometabolic multimorbidity (CMM), which was defined as co-existing with two or more cardiometabolic diseases, including primary hypertension, type 2 diabetes, stroke, heart diseases (eg. coronary heart disease, arrhythmia, heart failure, myocardial infarction, and cardiac valve diseases), dyslipidemia, and obesity;
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.