NCT07305272

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 21, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 15, 2025

Last Update Submit

January 18, 2026

Conditions

Keywords

Heart FailureNutrition EducationAnimation VideoDietary BehaviorSymptom SeverityQuality of LifeRandomized Controlled Trial

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients 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.

Behavioral: Animation Video-Supported Nutrition Education

Control Group

NO INTERVENTION

Patients 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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 22004181BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 15, 2025

First Posted

December 26, 2025

Study Start

June 16, 2025

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

January 21, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning after publication of the primary results and available upon reasonable request.
Access Criteria
Researchers who provide a methodologically sound proposal and agree to the terms of a data use agreement. Requests will be reviewed by the principal investigator. Access will be provided for academic, non-commercial research purposes only.

Locations