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Recruiting NCT07158697

Health Chat for Empowerment-based Lifestyle Planning for Cardiometabolic Multimorbidity

No phase Interventional Cardiometabolic Diseases Multimorbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HcELP_CMM, Usual Care.
Who it may be relevant to
Registry conditions: Cardiometabolic Diseases, Multimorbidity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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?

Detailed 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 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.

Interventions

  • Behavioral HcELP_CMM
    Participants in this group 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 settin
  • Behavioral Usual Care
    Participants in this group 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.

Primary outcome measures

  • Eligibility rate [Time frame: Eligibility rate will be assessed at baseline only in the pilot part.]
  • Recruitment rate [Time frame: Recruitment rate will be assessed at baseline only in the pilot part.]
  • Adherence rate [Time frame: Adherence rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
  • Reasons for refusal to participate the program [Time frame: Reasons for refusal to participate the program will be assessed at baseline only in the pilot part.]
  • Participant's engagement experiences, feedback about the study design, and perceived program effects. [Time frame: 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.]
  • Attrition rate [Time frame: Attrition rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
  • Engagement rate [Time frame: Engagement rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
  • Reasons of non-engagement [Time frame: Reasons of non-engagement will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
  • Exposure to empowerment videos [Time frame: Exposure to empowerment videos will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
  • Completion rate [Time frame: Completion rate will be assessed through study completion (an average of 12 weeks) in the pilot part only.]
Secondary outcome measures (12)
  • Lifestyle behaviors [Time frame: 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.]
  • Blood pressure [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]
  • Symptom burden [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

China · 3 centers
  • Gusu District Feng Men Street Community Health Service Center — Suzhou
  • Gusu District Jinchang Street Bailian Community Health Service Center — Suzhou
  • Gusu District Shuang Ta Street Jinfan Community Health Service Center — Suzhou

Identifiers

NCT: NCT07158697 · UW 25-383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗