Mobile-Based Telemedicine and Health-Related Quality of Life Among Patients With Chronic Heart Failure (MOBILE-HF) (MOBILE-HF)
Effectiveness of Mobile-Based Telemedicine on Health-Related Quality of Life Among Patients With Chronic Heart Failure: Protocol for a Quasi-Experimental Study
Chronic heart failure (CHF) is a long-term condition in which the heart is unable to pump blood effectively. It can cause symptoms such as shortness of breath, fatigue, swelling in the legs, and reduced ability to perform daily activities. These problems often reduce a patient's quality of life and may lead to frequent hospital visits.
This study will assess whether a mobile-based telemedicine program can improve the health-related quality of life of patients with chronic heart failure in Ethiopia.
In this study, 70 adult patients with chronic heart failure will be included. They will be divided into two groups: 35 patients will receive routine care plus mobile-based telemedicine support, and 35 patients will receive routine care only.
The mobile-based telemedicine program will include health education, medication reminders, lifestyle advice, and follow-up support delivered through phone calls and text messages over an 8-week period.
Patients' quality of life will be measured at the beginning of the study and again after 8 weeks using a standard questionnaire called the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
The main goal of the study is to determine whether mobile-based telemedicine improves quality of life compared with routine care alone. The study may also help improve self-care behaviors, medication adherence, and symptom control among patients with heart failure.
The findings may provide evidence to support the use of mobile health technologies as a simple and scalable approach to improve heart failure care in Ethiopia.
調査の概要
詳細な説明
Chronic heart failure (CHF) is a long-term cardiovascular condition that significantly impairs functional capacity and quality of life. Patients often experience persistent symptoms, reduced daily activity, and frequent hospital visits, particularly in settings with limited access to continuous follow-up care.
This study will evaluate the effectiveness of a mobile-based telemedicine intervention on health-related quality of life among CHF patients attending follow-up care at Menelik II Comprehensive Specialized Hospital, Addis Ababa, Ethiopia.
A quasi-experimental design with a nonequivalent control group pre-test and post-test approach will be used. A total of 70 eligible adult CHF patients will be included and assigned to either an intervention group (n = 35) or a comparison group (n = 35).
The intervention group will receive an 8-week mobile-based telemedicine program in addition to routine care. The program includes scheduled phone calls, text messages, and WhatsApp-based communication providing education, self-care guidance, medication adherence support, lifestyle modification advice, and symptom monitoring. The comparison group will receive routine standard care only.
Health-related quality of life will be measured at baseline and after 8 weeks using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The main outcome is the change in HRQoL between the two groups after the intervention period.
Data will be analyzed to determine the effect of the intervention on quality of life outcomes.
This study is expected to provide evidence on whether mobile-based telemedicine can improve patient-reported outcomes in CHF management and support its integration into routine cardiac care in resource-limited settings.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gudisa Bereda, B.Pharm, MPH cand
- 電話番号：+251-913118492
- メール：gudisabareda95@gmail.com
研究連絡先のバックアップ
- 名前：Javed Ahamad, Professor
- 電話番号：07512372960
- メール：jas.hamdard@gmail.com
研究場所
-
-
-
Addis Ababa、エチオピア
- 募集
- Menelik II Comprehensive Specialized Hospital
-
コンタクト：
- Menelik II Hospital
- 電話番号：+251-111550444
- メール：miicshresearch@gmail.com
-
-
参加基準
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
説明
Inclusion Criteria:
- Adults aged 18-65 years who will be diagnosed with CHF (NYHA class II⁃III)
- Patients with reduced left ventricular ejection fraction LVEF ≤ 40%
- Patient who will have access to a mobile phone and will be able to use it
- Patients who will be able to communicate in Amharic, Oromic, or English
- Patients who will provide written informed consent
- Patients who will be diagnosed with HF lasting ≥ 6 months, to be confirmed by echocardiography and clinical assessment
- Patients with no contraindications for mild to moderate physical activity
Exclusion Criteria:
- Patients with NYHA class IV or who will require intensive care at enrollment
- Patients with other severe medical conditions (e.g., end-stage renal disease, & end stage liver disease)
- Patients with severe cognitive impairment or psychiatric illness that will interfere with participation
- Patients already enrolled in another telemedicine or intervention study
- Pregnant and lactating women
研究計画
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：非ランダム化
- 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 |
|---|---|
|
実験的：Mobile-Based Telemedicine + Routine Care
Arm 1 Arm Name: Intervention Group (Mobile-Based Telemedicine + Routine Care) Description: Participants in this arm will receive routine heart failure care provided at the cardiac clinic in addition to an 8-week mobile-based telemedicine intervention. Intervention(s): Behavioral Intervention: Mobile-Based Telemedicine Scheduled mobile phone calls SMS/text messages WhatsApp-based educational messages Health education on heart failure management Medication adherence support Diet and lifestyle counseling Symptom monitoring and follow-up support |
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
|
|
アクティブコンパレータ：Routine Care Only
Arm 2 Arm Name: Control Group (Routine Care) Description: Participants in this arm will receive standard routine heart failure care provided at the cardiac clinic without additional mobile-based telemedicine support. Intervention(s): Standard Clinical Care Routine follow-up visits Usual medical management for chronic heart failure |
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
|
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 |
|---|---|---|
|
Health-Related Quality of Life (HRQoL)
時間枠：Baseline and 8 weeks after intervention
|
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
The MLHFQ is a 21-item validated disease-specific instrument for patients with chronic heart failure.
Each item is rated on a 6-point Likert scale ranging from 0 (no impact) to 5 (very much impact), with total scores ranging from 0 to 105.
Lower scores indicate better quality of life.
The primary outcome will be the change in MLHFQ total score from baseline to 8-week follow-up between the intervention and control groups.
|
Baseline and 8 weeks after intervention
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gudisa Bereda、Marie Stopes International Ethiopia, Ambo, Ethiopia
出版物と役立つリンク
一般刊行物
- References 1. Kalwani NM, Koos H, Kohn E, et al. Impact of Initial Cardiology Telemedicine Evaluation on Follow-Up Visits for Common Conditions: Quasi-Experimental Study. J Med Internet Res. 2025;27(e73509). 2. Gomez T, Anaya YB, Shih KJ, et al. A qualitative study of primary care physicians' experiences with telemedicine during COVID-19. J Am Board Fam Med. 2021;34: S61-S70. 3. Joshi M, Koos HT, Sandhu A, et al. Impact of clinician telemedicine use on new medication orders for patients with heart failure with reduced ejection fraction. J Am Coll Cardiol. 2024;83(13):632. 4. Arian M, Valinejadi A, Soleimani M. Quality of Life in Heart Patients Receiving Telerehabilitation: An Overview with Meta-Analyses. Iran J Public Health. 2022;51(11):2388-403. 5. Wang C, Ba Y, Ni J, et al. Role of telemedicine intervention in the treatment of patients with chronic heart failure: A systematic review and meta-analysis. Anatol J Cardiol 2024;28(4):177-86. 6. Wańczura P, Aebisher D, Wiśniowski M, et al. Telemedical Intervention and Its Effect on Quality of Life in Chronic Heart Failure Patients: The Results from the Telemedicine and e-Health Solution Pilot Program. J Clin Med. 2024; 13:2604. 7. Azimi, I., Taherkhani, A., Rahmani, A.M., et al. Missing data resilient decision-making for healthcare IoT through personalization: A case study on maternal health. Future Gener Comput Syst. 2019; 96:297-308. 8. Tefera YG, Abegaz TM, Abebe TB, et al. The changing trend of cardiovascular disease and its clinical characteristics in Ethiopia: a hospital-based observational study. Vasc Health Risk Manag. 2017; 13:143-151. 9. Khezerlou Z, Aghakhani, N., Cheraghi, R., et al. Effect of self-care education via distance learning and the reversal method on self-care behaviors and quality of life in patients with heart failure: A quasi-experimental study. J Nurs Adv Clin Sci. 2025;2(2):63-70.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- S/C/038/18
- 928411 (レジストリ識別子：Gudisa Bereda)
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?
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
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。