Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge (ACS)
2026年9月2日 更新者：Nanfang Hospital, Southern Medical University
Construction and Empirical Study of a "Hospital-to-Home" Self-Management Support Model for ACS Patients Based on the Integrated COM-B and HAPA Models
This randomized controlled trial evaluates a "Hospital-to-Home" self-management support model for Acute Coronary Syndrome (ACS) patients, which is based on the integrated COM-B and HAPA theories.
Participants are randomly assigned to either an intervention group receiving a structured self-management program or a control group receiving standard education.
The study compares self-management behaviors and health outcomes between the two groups to assess the model's effectiveness.
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)
80
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：Department of Cardiology, Nanfang Hospital
- 電話番号：020-62707277
- メール：243206095@qq.com
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510515
- Nanfang Hospital, Southern Medical University
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コンタクト：
- Department of Cardiology, Nanfang Hospital
- 電話番号：020-62707277
- メール：243206095@qq.com
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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:
- Diagnosed with acute coronary syndrome (ACS) according to the Guidelines for the Rapid Emergency Diagnosis and Treatment of Acute Coronary Syndrome (2019), based on electrocardiogram (ECG), serological tests, and symptomatology.
- Age ≥ 18 years.
- Mentally alert, with unimpaired communication skills, and adequate reading and expressive abilities.
- Patient, or their primary caregiver, able to use the study communication tool (WeChat).
Exclusion Criteria:
- Advanced or terminal stage of disease with expected survival less than 12 months.
- Severe physical comorbidities (e.g., decompensated cardiac, hepatic, or renal function).
- Motor dysfunction or mobility impairment.
- Currently participating in or previously participated in a similar clinical study.
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：なし（オープンラベル）
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：Intervention Group
Participants receive the structured self-management support program based on the integrated COM-B and HAPA models, including enhanced education and follow-up support.
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This intervention is based on the integrated HAPA and COM-B models.
Using HAPA, patients are categorized into three phases: pre-action (contemplation), action initiation (early post-discharge), and behavior maintenance (≥1 month post-discharge).
Prior to discharge, a COM-B assessment identifies individual barriers and facilitators across capability, opportunity, and motivation.
Tailored self-management support is then delivered according to the patient's phase and COM-B profile.
The core intervention consists of one in-depth inpatient interview and three outpatient sessions for self-management planning, execution, and confirmation.
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アクティブコンパレータ：Control Group
Participants receive standard care and routine health education.
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Participants receive routine health education and standard care according to the hospital's standard clinical pathway for ACS patients.
This includes basic discharge instructions, brochures on heart-healthy lifestyles, and routine outpatient follow-up appointments.
No additional structured self-management support or extra telephone follow-ups are provided beyond standard care.
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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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Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
時間枠：At baseline and at 13, 36, and 60 weeks of follow-up.
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The Heart Health Self-Efficacy and Self-Management Scale (HHSES) is a 12-item instrument assessing participants' self-efficacy and self-management behaviors.
Total scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better self-efficacy and self-management.
Scores ≥36 indicate high self-efficacy and self-management; 25-35 indicate a moderate level; and ≤24 indicate a low level.
Administered at baseline and at 13, 36, and 60 weeks of follow-up.
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At baseline and at 13, 36, and 60 weeks of follow-up.
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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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Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
時間枠：From the end of treatment through 60 weeks of follow-up
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Major adverse cardiovascular events (MACE) is a composite outcome defined as the occurrence of heart failure, angina, arrhythmia, or recurrent myocardial infarction.
Reported as number and proportion of participants experiencing any component event and/or the composite MACE.
Assessed from the end of treatment through 60 weeks of follow-up.
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From the end of treatment through 60 weeks of follow-up
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Emergency department visit rate for cardiac-related reasons
時間枠：From the end of treatment through 60 weeks of follow-up
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Proportion of participants with emergency department visits for cardiac-related reasons during the follow-up period.
Calculated as (number of participants with cardiac-related emergency department visits ÷ total number of eligible participants at start of follow-up) × 100%.
Assessed from the end of treatment through 60 weeks of follow-up.
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From the end of treatment through 60 weeks of follow-up
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Social Support Rating Scale (SSRS) score
時間枠：At baseline and at 13, 36, and 60 weeks of follow-up
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The Social Support Rating Scale (SSRS) is a 10-item instrument assessing social support along three dimensions: objective support, subjective support, and utilization of social support.
Total scores range from 13 to 70.
Scores < 33 indicate low social support; 33-45 indicate moderate social support; and > 45 indicate high social support.
Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score
時間枠：At baseline and at 13, 36, and 60 weeks of follow-up
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The Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) is a 9-item instrument measuring illness perception.
Total scores range from 0 (minimum) to 80 (maximum), with higher scores indicating worse/more negative illness perception (stronger perceived threat or more negative views toward the illness).
Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Cardiovascular re-hospitalization rate
時間枠：Assessed from the end of treatment through 60 weeks of follow-up.
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Proportion of participants re-hospitalized for cardiovascular reasons (e.g., heart failure, angina, arrhythmia, recurrent myocardial infarction) during the 12-month period after the end of treatment.
Calculated as (number of participants re-hospitalized for ACS-related cardiovascular reasons during the follow-up period ÷ total number of eligible patients at the start of the follow-up period) × 100%.
Assessed from the end of treatment through 60 weeks of follow-up.
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Assessed from the end of treatment through 60 weeks of follow-up.
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Medication Adherence Report Scale (MARS-10) score
時間枠：Assessed at 13, 36, and 60 weeks of follow-up.
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The Medication Adherence Report Scale (MARS-10) is a 10-item self-report questionnaire using a dichotomous yes/no response format.
It evaluates medication adherence across three dimensions: medication adherence behavior, attitude toward taking medication, and negative side effects and attitudes toward medication.
Total scores range from 0 to 10.
A score ≤ 5 indicates medication non-adherence, and a score ≥ 6 indicates medication adherence.
Assessed at 13, 36, and 60 weeks of follow-up.
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Assessed at 13, 36, and 60 weeks of follow-up.
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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9月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年8月18日
QC基準を満たした最初の提出物
2026年8月30日
最初の投稿 (実際)
2026年9月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月4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9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NFEC-2026-428
- 2025CR031 (その他の助成金/資金番号：2025 Nanfang Hospital of South)
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?
はい
IPD プランの説明
De-identified individual participant data (IPD) including baseline characteristics, intervention implementation data, and primary and secondary outcome measures will be shared.
The data sharing plan has been approved by the institutional ethics committee and included in the informed consent process.
IPD 共有時間枠
Data will be available starting from 6 months after the publication of the main results and will remain accessible for a period of 3 years.
IPD 共有アクセス基準
Access will be granted to qualified researchers (clinicians and nursing scientists) who propose to use the data for legitimate scientific purposes.
Interested researchers can submit a data request to the Principal Investigator via email.
A data use agreement must be signed prior to data access.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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