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

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Etiopien
      • Addis Ababa, Etiopien
        • Rekruttering
        • Menelik II Comprehensive Specialized Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Andet: Supportive Care
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Aktiv komparator: 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
Andet: Supportive Care
Health-related quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-Related Quality of Life (HRQoL)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Select College

Efterforskere

  • Ledende efterforsker: Gudisa Bereda, Marie Stopes International Ethiopia, Ambo, Ethiopia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. marts 2026

Primær færdiggørelse (Anslået)

1. juli 2026

Studieafslutning (Anslået)

21. august 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S/C/038/18
  • 928411 (Registry Identifier: Gudisa Bereda)

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