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

Official title

Effectiveness of Mobile-Based Telemedicine on Health-Related Quality of Life Among Patients With Chronic Heart Failure: Protocol for a Quasi-Experimental Study

Overview

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.

Detailed description

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.

Interventions

• Other Supportive Care
  Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).

Primary outcome measures

• Health-Related Quality of Life (HRQoL) [Time frame: Baseline and 8 weeks after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Ethiopia · 1 center

• Menelik II Comprehensive Specialized Hospital — Addis Ababa

Publications

• 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,

Identifiers

NCT: NCT07650474 · S/C/038/18 · 928411

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗