WhatsApp-Based Sleep Intervention in Heart Failure Patients
NCT ID: NCT06893575
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2025-03-27
2025-12-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial
NCT04210167
Online Psychological Support Group for Patients With Heart Failure and Depression
NCT05948241
Management of Telemedicine Monitoring of Patients With Chronic Heart Failure
NCT05885425
Teach Back Method in Individuals With Heart Failure
NCT06060223
The Effect of Video Training o Symptom Management With Heart Failure
NCT06068725
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sleep hygiene refers to a set of non-pharmacological strategies designed to promote better sleep quality. These strategies include:
* Maintaining a consistent sleep schedule
* Reducing screen time before bed
* Minimizing caffeine, alcohol, and nicotine consumption
* Creating a comfortable sleep environment
* Engaging in physical activity during the day while avoiding excessive daytime naps
Despite these well-established guidelines, adherence to sleep hygiene recommendations remains a challenge, particularly among HF patients. Behavior change in chronic illness management is complex, requiring systematic approaches that help individuals transition from awareness to action and long-term maintenance. One effective approach for guiding behavior change is the TTM. TTM outlines five distinct stages of change:
* Precontemplation: No intention to change behavior
* Contemplation: Awareness of the need for change but no action taken
* Preparation: Intention to adopt change in the near future
* Action: Active engagement in behavior change
* Maintenance: Sustained behavior over time TTM has been successfully applied to a range of chronic disease interventions, including smoking cessation, diabetes self-management, and hypertension control. However, its use in HF patients-particularly for sleep hygiene interventions-remains limited. Previous studies suggest that most HF patients remain in the contemplation or preparation stages, indicating the need for targeted, stage-specific interventions that facilitate sustainable behavior change.
This study aims to develop and test a WhatsApp-based, TTM-guided sleep hygiene intervention for HF patients, evaluating its impact on sleep quality and overall quality of life. The intervention integrates TTM principles with a digital platform to promote sustainable sleep hygiene behaviors. Unlike previous HF interventions, which primarily focus on general self-care education, this project specifically targets sleep hygiene, using WhatsApp to provide continuous support, reminders, and feedback.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TTM-Guided Digital Sleep Health Program
The experimental group will participate in a nurse-led intervention program titled "TTM-Guided Digital Sleep Health Program," designed to enhance sleep quality in HF patients.
The intervention consists of:
* Education Sessions (Weeks 1-4): Weekly face-to-face and telehealth training on sleep hygiene.
* WhatsApp-Based Support (Weeks 5-12): Daily messages with practical sleep strategies, reminders, and video content.
* Follow-Up Monitoring (Weeks 13-24): Weekly motivational messages to sustain behavior change.
Patients will track sleep data using smartwatches and share it via WhatsApp. The intervention follows the TTM, guiding patients through behavior change stages to improve and maintain sleep hygiene.
TTM-Guided Digital Sleep Health Program
This intervention is a TTM-based sleep health improvement program designed for HF patients. It includes three components: (1) Sleep health education sessions (Weeks 1-4) delivered face-to-face and via telehealth, (2) WhatsApp-based sleep hygiene support (Weeks 5-12) with daily reminders, educational messages, and video content, and (3) Follow-up monitoring (Weeks 13-24) with periodic motivational messages. Patients will track their sleep using smartwatches and share data via WhatsApp. The intervention guides behavior change through TTM stages, promoting sustainable sleep hygiene practices.
Usual care group
The control group will not receive any intervention and will continue their routine treatment and follow-up in the outpatient clinic. Surveys will be administered at designated data collection time points, and participants will be asked to keep a sleep diary for 14 days. At the end of the intervention (at the end of the 6th month), written educational material will be provided to individuals in the control group. This material will be created by compiling the sleep hygiene recommendations that were shared with the intervention group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TTM-Guided Digital Sleep Health Program
This intervention is a TTM-based sleep health improvement program designed for HF patients. It includes three components: (1) Sleep health education sessions (Weeks 1-4) delivered face-to-face and via telehealth, (2) WhatsApp-based sleep hygiene support (Weeks 5-12) with daily reminders, educational messages, and video content, and (3) Follow-up monitoring (Weeks 13-24) with periodic motivational messages. Patients will track their sleep using smartwatches and share data via WhatsApp. The intervention guides behavior change through TTM stages, promoting sustainable sleep hygiene practices.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Patients currently using sleep medications or sleep-regulating treatments. Individuals undergoing antidepressant or similar drug therapy.
* Patients with significant communication difficulties due to hearing or visual impairments or language barriers.
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abant Izzet Baysal University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Seyma Demir
Nursing researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Şeyma Demir Erbaş, PhD
Role: PRINCIPAL_INVESTIGATOR
Abant Izzet Baysal University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Izzet Baysal Training and Research Hospital
Bolu, Bolu, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AIBU-HSF-SDEMIR-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.