NCT07650474

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 2, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2026

Expected
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 10, 2026

Last Update Submit

June 15, 2026

Conditions

Health Related Quality of LifeChronic Heart Failure

Keywords

Health-related quality of lifeMobile-based telemedicineChronic heart failure

Outcome Measures

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.

    Baseline and 8 weeks after intervention

Study Arms (2)

Mobile-Based Telemedicine + Routine Care

EXPERIMENTAL

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

Other: Supportive Care

Routine Care Only

ACTIVE COMPARATOR

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

Other: Supportive Care

Interventions

Supportive CareOTHER

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

Mobile-Based Telemedicine + Routine CareRoutine Care Only

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menelik II Comprehensive Specialized Hospital

Addis Ababa, Ethiopia

RECRUITING

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gudisa Bereda

    Marie Stopes International Ethiopia, Ambo, Ethiopia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gudisa Bereda, B.Pharm, MPH cand

CONTACT

+251-913118492gudisabareda95@gmail.com

Javed Ahamad, Professor

CONTACT

07512372960jas.hamdard@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 16, 2026

Study Start

March 2, 2026

Primary Completion

July 1, 2026

Study Completion (Estimated)

August 21, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)