Self-management Intervention for People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial
2026年9月2日 更新者：Rui She、The Hong Kong Polytechnic University
A Multi-faceted Self-management Intervention for Improving Patient Activation and Lifestyle Behavior Modification Among People With Cardiometabolic Multimorbidity: A Pilot Randomized Controlled Trial
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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
72
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rui She, PhD
- 电话号码：+85227665693
- 邮箱：sherryshe0319@link.cuhk.edu.hk
学习地点
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Hong Kong
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Hong Kong、Hong Kong、中国
- The Hong Kong Polytechnic University
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接触：
- Rui She, PhD
- 电话号码：+852 2766 5693
- 邮箱：sherryshe0319@link.cuhk.edu.hk
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：MSP-MI
The intervention will comprise two biweekly telephone consultations, conducted by well-trained RAs with expertise in social science, health psychology, or behavioral medicine.
These consultations will utilize MI blended with behavioral change techniques, including self-affirmation and problem-solving training.
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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.
其他名称：
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安慰剂比较：Usual care
The control group will receive usual care accordingly to government guidelines.
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The control group will receive usual care accordingly to government guidelines.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Retention rate at 3 months
大体时间：From randomization to the end of intervention at 3 months
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Proportion of randomized participants who complete the 3-month primary assessment
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From randomization to the end of intervention at 3 months
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Intervention adherence rate
大体时间：From enrollment to the end of intervention
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Proportion of participants who attend all the scheduled intervention sessions
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From enrollment to the end of intervention
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Recruitment rate
大体时间：From the start of recruitment to completion of enrollment
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Proportion of eligible individuals who consent and are randomized.
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From the start of recruitment to completion of enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in mental health from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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Mental health will be assessed using the Patient Health Questionnaire-4, with higher scores indicating greater mental distress.
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From baseline to the end of intervention at 3 months
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Change in patient activation from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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Change in health behavior from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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Change in motivation for behavior change from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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Change in self-efficacy for managing chronic disease from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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Change in health-related quality of life from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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Change in self-rated health status from baseline to 3 months
大体时间：From baseline to the end of intervention at 3 months
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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.
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From baseline to the end of intervention at 3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Qualitative process evaluation of intervention feasibility and acceptability
大体时间：From enrollment to the end of intervention at 3 months
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Approximately 20-30 participants will be invited to participate in semi-structured interviews, or until thematic saturation is reached.
Interviews will explore participants' experiences, perceived feasibility, acceptability, barriers, and facilitators related to the intervention.
Qualitative data will be audio-recorded, transcribed, and analyzed thematically.
Findings will be reported narratively and will not be aggregated into a single quantitative score.
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From enrollment to the end of intervention at 3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：rui she, PhD、The Hong Kong Polytechnic University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2027年10月31日
研究完成 (估计的)
2027年10月31日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月25日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- Ref. 22231741
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
he data sharing plan has not yet been finalized and will be determined in accordance with participant consent, institutional policies, and ethics approval requirements.
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.