Heart FailureWhatSleeP-HFNCT06893575
WhatsApp-Based Sleep Intervention in Heart Failure Patients
A study testing TTM-Guided Digital Sleep Health Program in people with Heart Failure and Sleep Problems, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Heart Failure, Sleep Problems
- What is being tested?
- TTM-Guided Digital Sleep Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2025to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izzet Baysal Training and Research Hospital
Bolu, Bolu, 14230
About this study
Official title: 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
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).
Read more
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.
Read the detailed description
HF is a major global health concern, particularly in aging populations. In Turkey, HF prevalence reached approximately 2.114% in 2022, affecting nearly three million individuals. The condition leads to high hospitalization rates and significant healthcare costs. Given its increasing prevalence, improving self-care behaviors among HF patients is crucial. HF is a chronic disease that impairs the heart's ability to pump blood efficiently, leading to symptoms such as dyspnea, fatigue, and fluid retention. Beyond physical symptoms, HF patients frequently experience psychological issues like depression and anxiety, further compromising their QoL. Among the key determinants of reduced QoL in HF patients is poor sleep quality, which affects daily functioning and overall health status. Studies indicate that HF patients frequently suffer from sleep disturbances, including insomnia, obstructive sleep apnea (OSA), and central sleep apnea (CSA), all of which contribute to disease progression and increased morbidity risk. Addressing sleep quality in HF patients is an essential component of improving disease management and patient outcomes. Nurses, as key healthcare providers, play a pivotal role in implementing interventions to improve sleep hygiene, a critical yet often overlooked aspect of HF care. However, behavior change in sleep hygiene requires structured, evidence-based interventions that account for the complexities of adopting new habits.
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
- Heart Failure, Sleep Problems
- Being tested
- TTM-Guided Digital Sleep Health Program
- Keywords
- heart failure, sleep problems, whatsapp
- Medical subject headings
- Heart Failure, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTM-Guided Digital Sleep Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from baseline to six months
Secondary outcomes (1)
Subjective Sleep Quality
MLHFQ was developed in 1987 to assess quality of life in HF patients. The scale consists of 21 items divided into two subdomains: physical functioning (8 items: 2,3,4,5,6,7,12,13) and emotional well-being (5 items: 17,18,19,20,21). Items are rated on a Likert scale from 0 (no impact) to 5 (very much impact). Subdomain scores are obtained by summing responses in each category, while the total score (0-105) reflects overall quality of life. Physical function scores range from 0 to 40, and emotional scores from 0 to 105. Lower scores indicate better quality of life (less dysfunction). The scale was adapted into Turkish with validity and reliability studies conducted in 2009, showing Cronbach's alpha values above 0.70 for subdomains and total scores.
Measured: from baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start27 Feb 2025
- Primary completion27 May 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Demir, Abant Izzet Baysal University
- Investigators
- Şeyma Demir Erbaş, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893575
- Sponsor's protocol ID
- AIBU-HSF-SDEMIR-06
- Acronym
- WhatSleeP-HF
- Status last verified
- May 2026
- First submitted
- 18 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06893575
- Acronym / sponsor ID
- WhatSleeP-HF / AIBU-HSF-SDEMIR-06
- Conditions
- Heart Failure, Sleep Problems
- Keywords
- heart failure, sleep problems, whatsapp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HF is a major global health concern, particularly in aging populations. In Turkey, HF prevalence reached approximately 2.114% in 2022, affecting nearly three million individuals. The condition leads to high hospitalization rates and significant healthcare costs. Given its increasing prevalence, improving self-care behaviors among HF patients is crucial. HF is a chronic disease that impairs the heart's ability to pump blood efficiently, leading to symptoms such as dyspnea, fatigue, and fluid retention. Beyond physical symptoms, HF patients frequently experience psychological issues like depression and anxiety, further compromising their QoL. Among the key determinants of reduced QoL in HF patients is poor sleep quality, which affects daily functioning and overall health status. Studies indicate that HF patients frequently suffer from sleep disturbances, including insomnia, obstructive sleep apnea (OSA), and central sleep apnea (CSA), all of which contribute to disease progression and increased morbidity risk. Addressing sleep quality in HF patients is an essential component of improving disease management and patient outcomes. Nurses, as key healthcare providers, play a pivotal role in implementing interventions to improve sleep hygiene, a critical yet often overlooked aspect of HF care. However, behavior change in sleep hygiene requires structured, evidence-based interventions that account for the complexities of adopting new habits.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTM-Guided Digital Sleep Health Program | Experimental | Behavioral: TTM-Guided Digital Sleep Health ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTM-Guided Digital Sleep Health ProgramThis 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. | Behavioural | TTM-Guided Digital Sleep Health Program |
Primary outcome
Sleep quality
Time frame: from baseline to six months
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.
Sleep hygiene
Time frame: from baseline to six months
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.
1 secondary outcome
Subjective Sleep Quality
Time frame: from baseline to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyma Demir Erbaş, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTM-Guided Digital Sleep Health Program in people with Heart Failure and Sleep Problems, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: from baseline to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.