NCT06060223

Brief Summary

This study will be conducted to determine the effect of the training given to indivuduals with heart failure by teach back method on their symptom control, adherence to treatment and self care behaviours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2022

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

October 3, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

September 23, 2023

Last Update Submit

February 14, 2024

Conditions

Keywords

patienteducation

Outcome Measures

Primary Outcomes (3)

  • Morsky Treatment Compliance Scale (MTUÖ-8)

    The scale consists of seven yes/no closed-ended questions with two options and one closed-ended question with five options. 1 point is given for answering no to questions one, two, three, four, six and seven, and 1 point is given for answering yes to question five. The eighth question consists of a multiple choice question called Likert type.A high score from the scale indicates high compliance with treatment.

    3 months

  • European Heart Failure Self-Care Behavior Scale-12

    The scale applied to measure the self-care behaviors of patients with heart failure has been determined as a scale that provides results in a short time, does not require separate training, and can be applied by the patients themselves. Identifying symptoms related to heart failure such as edema, respiratory distress, and fatigue; It is a Likert-type scale consisting of 12 questions that measures self-care assessment actions such as regular use of medications for these symptoms, fluid and salt restriction, communication with healthcare personnel, and weight monitoring.A high total score indicates low self-care, a low score indicates high self-care.

    3 months

  • Heart Failure Symptom Status Scale

    Developed by et al. aimed to evaluate the presence, frequency and severity of seven main symptoms, such as dyspnea during the day, dyspnea while lying down, fatigue, angina, edema, sleep problems, dizziness or loss of balance, which are the most common in HF patients, and to what extent each of them affects the patient.

    3 months

Study Arms (2)

Teach Back Method

EXPERIMENTAL

Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.

Other: Teach Back Method

Control

NO INTERVENTION

Patients in the control group will participate in standard educational practices implemented in the clinic.Patients will be contacted by phone 3 months after discharge. Data collection forms will be applied as a final test.

Interventions

Training and consultancy services based on the teach-back method will be provided to individuals in the training group using the "Heart Failure Training Guide" in the form of 3 follow-ups in the cardiology clinic and telephone counseling. Telephone interviews were conducted by the researcher in the first week after discharge, it will be held in the first month and 3rd month. In addition, patients will receive counseling by calling the researcher if necessary.

Teach Back Method

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with heart failure at least 6 months ago
  • Individuals who speak and understand Turkish
  • Able to communicate by phone
  • İndividuals who can read and write
  • Those who gave consent to participate in the research

You may not qualify if:

  • under 18 years old
  • Patients with cognitive dysfunction
  • Those with neuro-psychiatric disease
  • Those who did not consent to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Merkez, Amasya, 05100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Neşe Uysal

    Amasya U

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2023

First Posted

September 29, 2023

Study Start

October 3, 2022

Primary Completion

February 14, 2024

Study Completion

February 14, 2024

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations