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Heart FailureNCT07305272

Evaluation of the Effect of Animated Video-Assisted Nutrition Education on Heart Failure Patients

A study testing Animation Video-Supported Nutrition Education in people with Heart Failure, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial aims to evaluate the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Heart Failure
What is being tested?
Animation Video-Supported Nutrition Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Jun 2025to 30 Dec 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 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who have been diagnosed with heart failure at least six months ago,
  • Are between the ages of 45-60,
  • Are in NYHA stage II or III,
  • Have a mobile phone capable of watching videos,
  • Volunteer to participate in the study will be included in the study.

Who cannot join

  • Individuals with HF who were included in the study as a sample,
  • Patients with fluid restriction under a different protocol (e.g., Chronic Renal Failure),
  • Patients with chronic pulmonary disease (e.g., COPD),
  • Illiterate,
  • Do not own a mobile phone capable of watching videos,
  • Have physical or cognitive impairments,
Show all 9Show fewer
  • Have a psychiatric illness,
  • Refuse to participate in the study will not be included in the study.
  • Patients hospitalized during the study period will be excluded from the study, and their data will not be subject to statistical analysis.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Tokat Gaziosmanpaşa University

    Tokat Province, Tokat Province, 60100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Animated Video-Assisted Nutrition Education on Nutritional Behaviors, Symptom Severity, and Quality of Life in Heart Failure Patients

This randomized controlled trial aims to evaluate the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure. A total of 70 patients aged 45-60 years with NYHA class II or III heart failure will be recruited at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic. Participants will be randomly assigned to an intervention group, which will receive video-supported nutrition education, or a control group, which will receive standard care. Outcomes will be assessed using the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, and Minnesota Living with Heart Failure Questionnaire at baseline, 1 month, 3 months, and 6 months.

Read the detailed description

This study investigates the effect of animation video-supported nutrition education on dietary behaviors, symptom severity, and quality of life in patients with heart failure (HF). The study will be conducted at Tokat Gaziosmanpaşa University Research and Application Hospital Cardiology Clinic from July 2025 to December 2025. A total of 70 patients aged 45-60 years with NYHA class II or III HF will be included. Patients meeting the inclusion criteria and willing to participate will be randomly assigned to the intervention or control group using a computer-based simple randomization method.

The intervention group will receive a structured nutrition education program delivered through animation videos developed based on clinical guidelines, focusing on balanced nutrition, sodium restriction, sugar and cholesterol control, and fluid retention prevention. Videos will illustrate key concepts using the "5W1H and Symptom" (What, Where, How, When, Why, Symptom) principle. Baseline assessments will include the Heart Failure Dietary Behavior Scale, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire, and a demographic form. Follow-up assessments will be conducted at 1 month, 3 months, and 6 months.

The control group will receive standard care, including verbal advice from cardiologists. After completion of the study, control group patients will also have access to the animation video education. Data will be analyzed using SPSS v25 with appropriate statistical tests, and linear mixed-effects models will be applied to evaluate group, time, and group-time interaction effects.

Conditions
Heart Failure
Being tested
Animation Video-Supported Nutrition Education
Keywords
Heart Failure, Nutrition Education, Animation Video, Dietary Behavior, Symptom Severity, Quality of Life, Randomized Controlled Trial
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Animation Video-Supported Nutrition EducationBehavioural

    Structured education using animation videos on balanced diet, sodium restriction, sugar/cholesterol control, fluid retention prevention. Videos delivered in hospital and accessible on patients' phones for 6 months with weekly reminders.

Study groups in NCT07305272
Study groupRoleWhat they receive
Intervention GroupExperimentalPatients will receive animation video-supported nutrition education focusing on balanced diet, sodium restriction, sugar and cholesterol control, and fluid retention prevention. Videos will follow the "5W1H and Symptom" principle. Follow-ups will be at 1 month, 3 months, and 6 months using HF Dietary Behavior Scale, HF Symptom Status Scale, and Minnesota Living with HF Questionnaire.
Receives: Behavioral: Animation Video-Supported Nutrition Education
Control GroupNo interventionPatients will receive standard care (verbal advice from cardiologists) and will complete the same assessments at baseline, 1 month, 3 months, and 6 months. After study completion, they will also receive access to the animation video education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Score on the Heart Failure Dietary Behavior Scale

    Dietary behaviors will be evaluated using the Heart Failure Dietary Behavior Scale, developed by Boy and Enç (2022). The scale consists of 19 items across four subscales: Healthy Habits, Salt Restriction, Sugar Restriction, and Prevention of Fluid Retention. Items are rated on a 4-point Likert scale, yielding a total score range of 19-76. Higher scores indicate better adherence to dietary recommendations. A cutoff score of 46 is used; scores ≥46 indicate adherence to guideline-recommended nutritional behaviors.

    Measured: At baseline, 1 month, 3 months, and 6 months

Secondary outcomes (2)

  1. Mean Score on the Heart Failure Symptom Status Scale (Symptom Severity)

    Symptom severity will be assessed using the Heart Failure Symptom Status Scale, developed by Heo et al. (2015). This patient-reported outcome measure evaluates the presence, frequency, severity, and degree of distress associated with seven common heart failure symptoms: daytime dyspnea, orthopnea, fatigue, chest pain, edema, sleep problems, and dizziness or lightheadedness. Each symptom is rated using 4-point Likert-type response options. A response of "0" indicates absence of the symptom. When a symptom is present, patients rate symptom frequency (1 = less than once per week to 4 = nearly every day), severity (1 = mild to 4 = very severe), and symptom-related distress (1 = almost none to 4 = very much). Scores for each symptom are calculated by summing frequency, severity, and distress ratings. Total scores range from 0 to 84, with higher scores indicating greater symptom severity.

    Measured: At baseline, 1 month, 3 months, and 6 months

  2. Mean Score on the Minnesota Living with Heart Failure Questionnaire (Quality of Life)

    Quality of life will be assessed using the Minnesota Living with Heart Failure Questionnaire, developed by Rector et al. (1992). The questionnaire consists of 21 items evaluating the impact of heart failure on patients' physical, emotional, and social functioning, including symptoms such as dyspnea, peripheral edema, fatigue, anxiety, and depressive symptoms. Eight items assess the physical dimension (score range: 0-40), and five items assess the emotional dimension (score range: 0-25); the remaining items contribute to the total score only. Each item is scored on a 6-point Likert scale ranging from 0 ("no impact") to 5 ("very much"). Total scores range from 0 to 105, with lower scores indicating better quality of life.

    Measured: At baseline, 1 month, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start16 Jun 2025
  3. Primary completion1 Dec 2025
  4. Study completion30 Dec 2025

Resources

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
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305272
Sponsor's protocol ID
GOU-2025-RCT-001
Status last verified
Nov 2025
First submitted
15 Nov 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in the primary and secondary outcome analyses, including outcome measure scores and relevant baseline characteristics.

Publications

  • Veroff DR, Sullivan LA, Shoptaw EJ, Venator B, Ochoa-Arvelo T, Baxter JR, Manocchia M, Wennberg D. Improving self-care for heart failure for seniors: the impact of video and written education and decision aids. Popul Health Manag. 2012 Feb;15(1):37-45. doi: 10.1089/pop.2011.0019. Epub 2011 Oct 17.

    PubMed 22004181

Questions about this trial

What is this clinical trial studying?

A study testing Animation Video-Supported Nutrition Education in people with Heart Failure, run by Tokat Gaziosmanpasa 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 5 inclusion and 9 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 21 Jan 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?

Mean Score on the Heart Failure Dietary Behavior Scale (time frame: At baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07305272, which also lists 1 linked publication.

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 21 Jan 2026.

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