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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07650474
Acronym
MOBILE-HF
Enrollment
72
Registered
2026-06-16
Start date
2026-03-02
Completion date
2026-08-21
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Health Related Quality of Life

Keywords

Health-related quality of life, Mobile-based telemedicine, Chronic heart failure

Brief summary

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

OTHERSupportive Care

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

Sponsors

Select College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

This study will use a quasi-experimental non-randomized parallel assignment design. Eligible patients with chronic heart failure will be assigned to either an intervention group receiving mobile-based telemedicine plus routine care or a comparison group receiving routine care only. Both groups will be assessed at baseline (pre-test) and after 8 weeks (post-test) to evaluate changes in health-related quality of life. The groups will be followed concurrently in a real-world clinical setting without randomization.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health-Related Quality of Life (HRQoL)Baseline and 8 weeks after interventionHealth-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.

Countries

Ethiopia

Contacts

CONTACTGudisa Bereda, B.Pharm, MPH cand
gudisabareda95@gmail.com+251-913118492
CONTACTJaved Ahamad, Professor
jas.hamdard@gmail.com07512372960
PRINCIPAL_INVESTIGATORGudisa Bereda

Marie Stopes International Ethiopia, Ambo, Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026