NCT06893575Completed
WhatsApp-Based Sleep Intervention in Heart Failure Patients
WhatSleeP-HF Trial: The Effect of a WhatsApp-Based Sleep Intervention on Sleep Quality in Heart Failure Patients, Based on the Transtheoretical Model: Two Center, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
Heart failure (HF) is a growing global health issue, with increasing prevalence among aging populations. In Turkey, the prevalence of HF was 2.114% in 2022, affecting approximately three million individuals. HF patients often experience poor sleep quality due to symptoms like dyspnea, fatigue, and fluid retention, which significantly impact their overall health and quality of life. Sleep disorders, particularly obstructive and central sleep apnea, are commonly reported among HF patients, exacerbating disease progression and increasing morbidity. Nurses play a crucial role in improving HF patients' self-care behaviors, including sleep hygiene interventions. Sleep hygiene consists of non-pharmacological strategies to improve sleep quality, such as maintaining a regular sleep schedule, avoiding electronic devices before bed, and minimizing caffeine and alcohol intake. However, behavior change in sleep hygiene requires structured intervention models, such as the Transtheoretical Model (TTM), which provides a stepwise approach to behavioral change, moving individuals through different stages from precontemplation to maintenance. TTM has been successfully applied in chronic disease management, including smoking cessation, diabetes self-care, hypertension control, and physical activity promotion. However, its application in HF patients, particularly for sleep interventions, remains underexplored. The limited existing studies suggest that HF patients often remain in the contemplation or preparation stages, indicating the need for tailored interventions to facilitate behavior change. Advancements in digital health have enabled home-based sleep monitoring through wearable devices and mobile applications. Smartwatches, such as the Mi Band, provide real-time data on sleep parameters, offering a non-invasive alternative to traditional clinical sleep studies. Additionally, WhatsApp-based interventions have gained attention in healthcare, proving effective in chronic disease management by enhancing patient education, treatment adherence, and remote monitoring. WhatsApp facilitates real-time communication between patients and healthcare providers, reducing hospital readmissions and improving self-care practices. This study proposes a WhatsApp-based, TTM-guided sleep intervention for HF patients to improve sleep quality and self-care behaviors. Unlike previous studies, which primarily focus on general self-care education, this project integrates TTM with a digital platform to support sustained behavior change. Participants will receive personalized sleep hygiene guidance through WhatsApp, with regular reminders and real-time support. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) and Sleep Hygiene Index (SHI), alongside objective sleep parameters measured via smartwatches. The impact on quality of life (QoL) will be evaluated using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Hypotheses H1. The WhatsApp-based, TTM-guided sleep health program will significantly improve subjective sleep quality in HF patients. H2. The WhatsApp-based, TTM-guided sleep health program will significantly improve sleep hygiene in HF patients. H3. The WhatsApp-based, TTM-guided sleep health program will significantly improve quality of life in HF patients. This project is the first study to integrate TTM-based behavior change strategies with a WhatsApp sleep intervention for HF patients. The findings will provide novel insights into digital health interventions for chronic disease management and offer a scalable, cost-effective approach to improving sleep hygiene in HF populations.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 18 Mar 2025
- Start date
- 27 Feb 2025
- Primary completion date
- 27 May 2025
- Lead sponsor
- Abant Izzet Baysal University
- Diseases
- Heart failure
- NCT number
- NCT06893575
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 27 Feb 2025 to the primary completion date, 27 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients currently using sleep medications or sleep-regulating treatments. Individuals undergoing antidepressant or similar drug therapy.
Other illness
- Presence of severe cognitive impairment (e.g., dementia, Alzheimer's disease) that may negatively affect the ability to use WhatsApp (Standardized Mini-Mental Test score \< 25).
Other
- Patients with significant communication difficulties due to hearing or visual impairments or language barriers.
Who the study is looking for
- Confirmed heart failure (HF) diagnosis for at least one year by a physician with echocardiographic verification.
- Echocardiographically confirmed left ventricular ejection fraction (LVEF) \< 40%.
- Individuals with poor sleep quality and experiencing sleep problems (PSQI score ≥ 5).
- Not enrolled in any sleep improvement intervention program.
- Possessing a device capable of using WhatsApp (smartphone, tablet, computer, etc.) and having the necessary technical proficiency.
- Willingness to participate in the study
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Izzet Baysal Training and Research Hospital Coordinator of this site? Confirm its status | Bolu | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.