Medication Training Via Ignite Based on Roy Model in Heart Failure: Medication Adherence and Symptom Management

NCT07538596 | Not Yet Recruiting

• 1 other identifier: E-46418926-050.04--539411
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a structured medication training program can help people with heart failure better manage their condition. The program is based on the Roy Adaptation Model and is designed to support how people adjust to their illness. The main questions it aims to answer are: Does the training program improve heart failure symptoms? Does the training program help participants take their medications as prescribed? Researchers will compare a training program group to a control group receiving standard care to see if the program is effective. Participants will: Be randomly assigned to either a training program group or a control group Receive the training program through WhatsApp after hospital discharge or receive standard discharge education Be followed for 12 weeks Complete questionnaires at the start of the study, at 4 weeks, and at 12 weeks

Conditions

Hearth Failure With Reduced Ejection Fraction (HFrEF)

Keywords

hearth failure; roy adaptation; nurse care; digital presentation; education

Outcome Measures

Primary Outcomes (1)

• Heart Failure Symptom Status Scale

  This scale is used to assess the symptom burden associated with heart failure. Total scores range from 0 to 84, with higher scores indicating poorer health status and lower scores indicating better health status.

  20 minutes

Secondary Outcomes (1)

• Medication Adherence Report Scale

  5 minutes

Study Arms (2)

Control Group - Standard Care

NO INTERVENTION

Participants will receive routine hospital discharge education and standard care. They will complete symptom and medication adherence scales at baseline, 4 weeks, and 12 weeks. No digital training will be provided during the study period.

Intervention Group - Ignite-Based Medication Training

EXPERIMENTAL

Participants will receive medication management training based on the Roy Adaptation Model delivered via an Ignite digital presentation. The training will be sent through WhatsApp, and participants will be followed at 4 and 12 weeks using symptom and medication adherence scales.

Other: Ignite-Based Medication Management Training

Interventions

Ignite-Based Medication Management Training OTHER

The intervention is a structured medication management training program based on the Roy Adaptation Model. It is delivered using an Ignite digital presentation format and sent to participants via WhatsApp. The content is developed using current evidence-based heart failure guidelines (AHA and ESC) and focuses on improving patients' adaptation to illness through four adaptive modes (physiological, self-concept, role function, and interdependence). Participants receive the training after discharge and are followed up at 4 and 12 weeks using standardized symptom and medication adherence scales.

Intervention Group - Ignite-Based Medication Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 years of age or older.
• Individuals who are willing to participate in the study
• No communication problems
• Having been diagnosed with KY for at least 6 months
• Having the ability to read, write and speak Turkish .
• Mildly reduced ejection fraction (left ventricular EF 41-49%)
• Individuals with WhatsApp application
• Individuals who can use a smartphone

You may not qualify if:

• Not being willing to participate in the study don't be under the age of 18
• Lack of ability to read, write and speak Turkish
• Low ejection fraction (left ventricle EF. 40%)
• Preserved ejection fraction (left ventricular EF.50%)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Suleyman Yalcin City Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Location

Study Officials

• ILKYAZ KARAHAN, MSc, RN

  Hamidiye University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ilkyaz karahan, MSc, RN

CONTACT

+90 0530 060 49 05; ilkyazkarahan97@gmail.com

Selda ÇELİK, PhD, RN, Prof.

CONTACT

+90 533 225 38 56; selda.celik@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: Participants will be assigned to two parallel groups: an intervention group and a control group. The intervention and control groups will be followed simultaneously, and outcomes will be compared between the two groups over the study period.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)