Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity (HcELP_CMM) Program: a Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 3
- 主要终点
- Eligibility rate
研究概览
简要总结
The goal of this study is to:
- assess the feasibility, acceptability, and the preliminary effects of the health chat for empowerment-based lifestyle planning for CMM (HcELP_CMM);
- 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;
- 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:
- If the HcELP_CMM program is feasible and acceptable?
- 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？
- 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？
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or above；
- •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;
- •Possessed a digital device installed with WeChat, as well as with an internet connection.
排除标准
- •Contraindications to exercise according to American College of Sports Medicine (ACSM), such as severe musculoskeletal disorders, severe cardiovascular diseases, or spinal nerve injury;
- •Diagnosis of psychiatric disease;
- •Has impaired cognitive function as indicated by an Abbreviated Mental Test Score (AMTS) ≤6;
- •Has impaired sensory or communication function which hider them participation in this program, such as hearing loss, vision loss, and unable to speak Mandarin.
研究组 & 干预措施
HcELP_CMM
Participants in the arm will attend a 12-week HcELP_CMM program. This program is a hybrid intervention involving two phases: 1) face-to-face goal-oriented health counseling (week 1); 2) WeChat-based enhanced healthy lifestyle empowerment 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) risk diagnostics; 2) risk communication; 3) goal setting; and 4)strengthen commitment to lifestyle change. Phase 2 covers two modules: 1) lifestyle change for better, and 2) effective lifestyle maintenance.
干预措施: HcELP_CMM (Behavioral)
Usual care
Participants in the arm will receive usual care provided by the CHCCs, which will include general health education on preventing and managing common diseases. They will not receive any components of the empowerment-based intervention.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Eligibility rate
时间窗: Eligibility rate will be assessed at baseline only in the pilot part.
Eligibility rate will only be measured in the pilot part，which will be calculated as eligible participants divided by screened participants.
Recruitment rate
时间窗: Recruitment rate will be assessed at baseline only in the pilot part.
Recruitment rate will only be measured in the pilot part, which will be calculated as randomized participants divided by eligible participants.
Adherence rate
时间窗: Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Adherence rate will only be measured in the pilot part, which will be calculated as participants who completed the program divided by randomized participants.
Reasons for refusal to participate the program
时间窗: Reasons for refusal to participate the program will be assessed at baseline only in the pilot part.
Reasons for refusal to participate the program will only be measured in the pilot part, which will be obtained from individual review.
Participant's engagement experiences, feedback about the study design, and perceived program effects.
时间窗: Participant's engagement experiences, feedback about the study design, and perceived program effects will be measured within one week after the completion of the intervention only in the pilot part.
Participant's engagement experiences, feedback about the study design, and perceived program effects will only be measured in the pilot part, which will be explored by the individualized semi-structured qualitative interviews with participants in the HcELP\_CMM group through synchronized online video interviewing via WeChat platform.
Attrition rate
时间窗: Attrition rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Attrition rate will only be measured in the pilot part, which will be calculated as participants dropping out divided by randomized participants.
Engagement rate
时间窗: Engagement rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Engagement rate will only be measured in the pilot part, which will be calculated as the number of sessions of structed activities participants attended.
Reasons of non-engagement
时间窗: Reasons of non-engagement will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Reasons of non-engagement will only be measured in the pilot part, which will be obtained from individual review.
Exposure to empowerment videos
时间窗: Exposure to empowerment videos will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Exposure to empowerment videos will only be measured in the pilot part, which will be calculated as ratio of views to videos distributed.
Completion rate
时间窗: Completion rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Completion rate will only be measured in the pilot part, which will be calculated as proportion of participants attending ≥80% of planned structured sessions.
Goal attainment level
时间窗: Goal attainment level will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Goal attainment level will only be measured in the pilot part, which will be calculated from submitted lifestyle self-evaluation logbooks.
Researcher-participant dialogues
时间窗: Researcher-participant dialogues will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Researcher-participant dialogues will only be measured in the pilot part, which will be analyzed from the recordings in WeChat.
Adverse events
时间窗: Adverse events will be assessed through study completion (an average of 12 weeks) in the pilot part only.
Adverse events will only be measured in the pilot part, which will be monitored throughout the intervention via self-reported adverse events.
次要结局
- Drinking status(This outcome will be collected at baseline.)
- Blood pressure(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Capillary fasting plasma glucose(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Waist circumference(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Body Mass Index(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Smoking status(This outcome will be collected at baseline.)
- Sleep duration at night(This outcome will be collected at baseline.)
- Symptom burden(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Depression(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Handgrip(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Time up-and-go test(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- 4-meter gait speed(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Health-related quality of life(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- 5-times-sit-to-stand test(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
- Income(This outcome will be collected at baseline.)
- Living conditions(This outcome will be collected at baseline.)
- Sleep quality(This outcome will be collected at baseline.)
- Exercise habit(This outcome will be collected at baseline.)
- Polypharmacy(This outcome will be collected at baseline.)
- Age(This outcome will be collected at baseline.)
- Gender(This outcome will be collected at baseline.)
- Education level(This outcome will be collected at baseline.)
- Marital status(This outcome will be collected at baseline.)
- Employment status(This outcome will be collected at baseline.)
- Lifestyle behaviors(In the pilot part, this outcome will be assessed at baseline and within one week post-intervention. In the full RCT part, an additional measurement will be conducted within one week after the completion of the two-month follow-up period.)
研究者
Jing Xi
PhD
The University of Hong Kong