Mobile-Based Telemedicine and Health-Related Quality of Life Among Patients With Chronic Heart Failure (MOBILE-HF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSelect College
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Supportive Care
Other interventionHealth-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Mobile-Based Telemedicine + Routine CareExperimental treatment 1 intervention
Group B: Routine Care OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Health-Related Quality of Life (HRQoL)
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.
Time frame
Baseline and 8 weeks after interventionSponsors and contacts
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Source ClinicalTrials.gov