The Impact of Audiovisual Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants
2026年6月3日 更新者：University of Malaya
The Impact of Structured Patient Education Material in Improving Clinical and Behavioural Outcomes in Home-Based Cardiac Rehabilitation Programme Participants: A Randomised Controlled Trial Study
The goal of this clinical trial is to find out if newly developed, culturally adapted educational videos-sent through a mobile messaging app-can help people with coronary heart disease do better in a home-based cardiac rehabilitation program in Malaysia.
The main questions it aims to answer are:
- Do the educational videos help participants improve their fitness?
- Do the videos help participants better understand heart health and stick to a healthy lifestyle?
Researchers will compare the educational videos to existing standard educational materials to see if the video-based education is more helpful for supporting rehabilitation at home.
Participants will:
- Take part in a 12-week home-based cardiac rehabilitation program
- Receive either educational videos or standard education materials
- Meet with the cardiac rehabilitation team every 4 weeks
- Complete a treadmill exercise test, blood tests, and questionnaires before and after the program.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
21
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。
研究場所
-
-
Kuala Lumpur
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Kuala Lumpur、Kuala Lumpur、マレーシア、50603
- Universiti Malaya Medical Centre
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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 as any form of ischaemic heart disease;
- Classified as low to moderate risk based on American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) criteria through Exercise Stress Test (EST);
- Cognitively intact and able to provide informed consent;
- Literate and capable of utilising educational material;
- Able to use and operate a smartphone with an exercise activity tracker (EAT).
Exclusion Criteria
- Classified as high risk according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR)
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention
The intervention group received an audiovisual version of Structured Patient Education Materials during Cardiac Rehabilitation Programme Phase 2, which were delivered via WhatsApp.
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Bilingual (Malaysian and English language) Audiovisual Structured Patient Education Materials that are culturally adaptable on secondary prevention cardiac risk factors, self-care and exercise recommendations.
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アクティブコンパレータ：Control
The control group received the standard visual-based educational materials currently used in UMMC's Cardiac Rehabilitation Program Phase 2, which were delivered via WhatsApp.
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Standard visual-based educational materials currently used in Cardiac Rehabilitation Programme Phase 2, Universiti Malaya Medical Centre
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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 |
|---|---|---|
|
Change from Baseline in Cardiovascular Fitness Measured using metabolic equivalents (METs) at Completion of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Metabolic equivalents (METs) obtained through the Exercise Stress Test (EST), employing the modified Bruce protocol. Higher metabolic equivalents of task (METs) value indicate greater energy expenditure, higher physical intensity, and generally a better level of cardiorespiratory fitness. Conversely, a lower METs value indicates lower energy expenditure, lighter activity, and potentially a poorer functional capacity. |
Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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 from Baseline of Blood Glucose in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Blood glucose level through Glycated haemoglobin (HbA1c) in %
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Change from Baseline of Low-Density Lipoprotein Cholesterol in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
|
Blood cholesterol through Low Density Lipoprotein (LDL) cholesterol in mmol/L
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
|
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Change from Baseline of Body Fat Composition in Clinical Parameters of Cardiovascular Risk Factors at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Body composition through waist circumference-to-height ratio (WHtR).
Waist circumference is measured in centimetres (cm).
Height is measured in centimetres (cm).
Then, waist circumference-to-height will be combined and reported in a ratio.
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Smoking Cessation in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Smoking status and cessation were recorded weekly by self-reported statement (Smoking or Not).
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Medication Adherence in Behavioural Parameter Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Medication adherence was assessed at the end of Cardiac Rehabilitation Phase 2 by asking participants to indicate the likelihood of missing daily medication by using the options 'compliant', 'once a month', 'once a week', or 'more than once a week'.
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Assessed at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Exercise Adherence Related to Lifestyle Changes at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Exercise adherence was tracked using the provided exercise activity tracker, with adherence defined as achieving an average of at least 150 minutes of exercise per week.
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Weekly assessment until the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Change from Baseline in Cardiovascular Health Knowledge Assessment at 12 Weeks of Cardiac Rehabilitation Programme Phase 2
時間枠：Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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The Attitudes and Beliefs about Cardiovascular Disease (ABCD) risk questionnaire.
Total scores range from 0 to 80 points.
Higher scores indicate better overall CVD risk awareness and a greater health belief in one's capability to prevent cardiovascular disease.
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Baseline and at the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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Understandability and Actionability of Education Materials at Completion of Cardiac Rehabilitation Programme Phase 2
時間枠：At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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The Patient Education Materials Assessment Tool (PEMAT) is a systematic method used to evaluate and score the understandability and actionability of patient education materials.
Total score of 100%, with higher percentages indicating better quality of the educational material in understandability and actionability.
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At the completion of Cardiac Rehabilitation Programme Phase 2 at 12 weeks
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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。
スポンサー
捜査官
- 主任研究者：Anwar Suhaimi、Universiti Malaya
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 (実際)
2023年7月19日
一次修了 (実際)
2025年1月8日
研究の完了 (実際)
2025年1月16日
試験登録日
最初に提出
2025年11月20日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月3日
最終確認日
2025年6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
- 2023717-12674
- PV019-2020 (その他の助成金/資金番号：UMSC C.A.R.E Fund Research Grant)
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?
いいえ
IPD プランの説明
IPD will not be shared with outside researchers, as the informed consent forms for this study did not include a provision for future sharing of individual participant data beyond the initial research team.
Therefore, IPD cannot be shared to protect participant autonomy.
医薬品およびデバイス情報、研究文書
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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