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Mobile-Based Telemedicine and Health-Related Quality of Life Among Patients With Chronic Heart Failure (MOBILE-HF) (MOBILE-HF)

2026年6月15日 更新者:Gudisa Bereda、Select College

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.

研究概览

详细说明

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

研究联系人备份

学习地点

      • Addis Ababa、埃塞俄比亚
        • 招聘中
        • Menelik II Comprehensive Specialized Hospital
        • 接触:

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:

  • 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

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:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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).
有源比较器: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).

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
Health-Related Quality of Life (HRQoL)
大体时间: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

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:Gudisa Bereda、Marie Stopes International Ethiopia, Ambo, Ethiopia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 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 (实际的)

2026年3月2日

初级完成 (估计的)

2026年7月1日

研究完成 (估计的)

2026年8月21日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • S/C/038/18
  • 928411 (注册表标识符:Gudisa Bereda)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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