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

NCT ID: NCT07305272

Last Updated: 2025-12-26

Study Results

Results pending

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.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Heart Failure Nutrition Education Animation Video Dietary Behavior Symptom Severity Quality of Life Randomized Controlled Trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

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.

Group Type EXPERIMENTAL

Animation Video-Supported Nutrition Education

Intervention Type BEHAVIORAL

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.

Control Group

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.

Group Type NO_INTERVENTION

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.

Animation Video-Supported Nutrition Education

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasemin BOY

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tokat Gaziosmanpaşa University

Tokat Province, Tokat Province, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22004181 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GOU-2025-RCT-001

Identifier Type: -

Identifier Source: org_study_id