WhatsApp-Based Sleep Intervention in Heart Failure Patients

NCT06893575 | Completed

• 1 other identifier: AIBU-HSF-SDEMIR-06
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Problems; Heart Failure

Keywords

heart failure; sleep problems; whatsapp

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  PSQI is the most widely used scale in international literature to assess subjective sleep quality. This scale was developed by Buysse et al. in 1989 and was adapted into Turkish with validity and reliability studies conducted by Ağargün et al. The diagnostic sensitivity of the PSQI is 89.6%, and its specificity is 86.5%. This self-report questionnaire allows for a detailed assessment of sleep quality, sleep disorders, and their severity over the past month. The scale consists of 18 items grouped into seven components. The maximum possible score is 21; scores above 5 indicate poor sleep quality, while scores below 5 indicate good sleep quality.

  from baseline to six months

• Sleep hygiene

  SHI is a 13-item scale designed to assess whether and how frequently individuals engage in activities that affect sleep hygiene. Each item is scored from 1 to 5, with a total score ranging from 13 to 65. The scale evaluates sleep schedule regularity, pre-sleep behaviors that may negatively impact sleep hygiene (e.g., tobacco or caffeine consumption, engaging in demanding tasks, computer use), sleep environment conditions, and pre-sleep anxiety levels. Higher scores indicate poorer sleep hygiene. The scale does not have a validated cutoff score. It was developed in 2006 and later adapted into Turkish with validity and reliability studies conducted in 2015.

  from baseline to six months

Secondary Outcomes (1)

• Subjective Sleep Quality

  from baseline to six months

Study Arms (2)

TTM-Guided Digital Sleep Health Program

EXPERIMENTAL

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.

Behavioral: TTM-Guided Digital Sleep Health Program

Usual care group

NO INTERVENTION

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.

Interventions

TTM-Guided Digital Sleep Health Program BEHAVIORAL

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.

TTM-Guided Digital Sleep Health Program

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Izzet Baysal Training and Research Hospital

Bolu, Bolu, 14230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure; Parasomnias

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Şeyma Demir Erbaş, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing researcher

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: March 27, 2025
• Primary Completion: October 5, 2025
• Study Completion: December 25, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

TU (1)