NCT06807671

Brief Summary

This study was conducted to evaluate the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of heart failure patients towards their disease. Planned visual education based on the Health Belief Model has positive effects on the attitudes, beliefs, and symptoms of heart failure patients towards their disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2021

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

September 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

December 26, 2024

Last Update Submit

January 29, 2025

Conditions

Keywords

heart failurehealth belief modelpatient trainingnursing

Outcome Measures

Primary Outcomes (1)

  • Data collection tool

    In order to monitor the effectiveness of the intervention in the study, a 6-month follow-up was conducted and data were collected from the intervention group 3 times (before the intervention, at 3 months and at 6 months) and from the control group twice (at the first interview and at 6 months) through data collection forms. HBM-based education program was applied to the intervention group as an intervention. Data collection tools were "Patient Information Form", "Memorial Symptom Assessment Scale - Heart Failure (MSAS-HF)" and "Health Belief Model Scale in Heart Failure (HBM-HF)". Patient Information Form: A total of 15 questions are included, including sociodemographic information (such as age, gender, marital status, education status, employment status, occupation and income status) and additional information regarding HF/HF treatment (perceived health status, compliance with diet, exercise, treatment compliance, regular doctor visits, etc.) of the participants.

    Pre-test

Secondary Outcomes (1)

  • Data collection tool

    3 month

Other Outcomes (1)

  • Data collection tool

    6-months / Post-test

Study Arms (2)

Control Group

NO INTERVENTION

No Intervention: Control group No intervention was made by the researcher during the study. Only data was collected. At the end of the study, visual training based on the planned Health Belief Model was given and all patients who continued the study were given brochures and heart-shaped key chains designed by the researchers.

Experimental Group

EXPERIMENTAL

Experimental: intervention group The sample of this simple-randomized controlled experimental study consisted of heart failure patients who applied to Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic between September 2021 and March 2022. Patients who were determined by drawing lots according to their protocol numbers using the simple random sampling method were assigned to the intervention group. Patients assigned to the intervention group were given planned training based on the Health Belief Model. The intervention group was followed up for six months. A total of three interviews were conducted with the intervention group (First interview, 3rd month interview and 6th month interview).

Other: Experimental Group

Interventions

Patients in the intervention group received HBM based training for a period of 6 months. During the training, one-on-one interviews were provided with each patient. Patients were shown a power point presentation, a brochure, and 3 training videos. Any questions patients had were answered one-on-one.

Also known as: Educational intervention
Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between 18 and 65,
  • Those with no communication problems,
  • Those diagnosed with NYHA I-II heart failure,
  • Those without cognitive impairment,
  • Those who can understand and speak Turkish,
  • Those who agree to participate in the study.

You may not qualify if:

  • Patients who do not agree to participate in the study,
  • Patients who want to leave the study,
  • Patients with NYHA III-IV heart failure diagnosis,
  • Patients diagnosed with cancer,
  • Patients with diabetic foot or amputation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Manisa, 45000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants in the study do not know whether they are in the experimental or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 26, 2024

First Posted

February 4, 2025

Study Start

September 1, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

It can be shared upon request, if the relevant ethics committee approves.

Shared Documents
CSR
Time Frame
starting 6 months after publication
Access Criteria
It can be shared upon request, if the relevant ethics committee approves.

Locations