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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Rui She, PhD
- 電話番号：+85227665693
- メール：sherryshe0319@link.cuhk.edu.hk
研究場所
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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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コンタクト：
- Rui She, PhD
- 電話番号：+852 2766 5693
- メール：sherryshe0319@link.cuhk.edu.hk
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Retention rate at 3 months
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in mental health from baseline to 3 months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Qualitative process evaluation of intervention feasibility and acceptability
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：rui she, PhD、The Hong Kong Polytechnic University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2027年10月31日
研究の完了 (推定)
2027年10月31日
試験登録日
最初に提出
2026年8月10日
QC基準を満たした最初の提出物
2026年8月25日
最初の投稿 (実際)
2026年8月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月8日
QC基準を満たした最後の更新が送信されました
2026年9月2日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Ref. 22231741
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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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いいえ
米国FDA規制機器製品の研究
いいえ
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