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

The Effect of Medication Management Training Delivered Via the Digital Presentation Format Ignite, Based on the Roy Adaptation Model, on Medication Adherence and Symptom Management in Individuals Diagnosed With Heart Failure

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hearth Failure With Reduced Ejection Fraction (HFrEF)
• Intervention / Treatment: Other: Ignite-Based Medication Management Training

Detailed Description

This study is a structured, theory-based randomized controlled trial designed to evaluate adaptation and self-management in patients with heart failure following hospital discharge.

The study is based on the Roy Adaptation Model, which conceptualizes individuals as adaptive systems responding to internal and external stimuli through four adaptive modes: physiological, self-concept, role function, and interdependence. This theoretical framework guides the development and implementation of the intervention.

The intervention consists of a structured digital medication management training program delivered after discharge. The program aims to improve medication adherence, enhance patients' understanding of their treatment regimens, and support adaptive responses to the challenges of living with heart failure. The educational content is standardized and provided through a remote format to ensure consistency and accessibility.

Participants will be assigned to intervention and control groups. While the intervention group receives the structured digital training program, the control group receives standard care.

Data will be collected at baseline and follow-up time points using validated instruments to assess adaptation and self-management behaviors. The study aims to determine the effectiveness of the intervention in improving patients' adaptation to heart failure and their ability to manage their condition.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ILKYAZ karahan, MSc, RN; Phone Number: +90 0530 060 49 05; Email: ilkyazkarahan97@gmail.com
• Study Contact Backup: Name: Selda ÇELİK, PhD, RN, Prof.; Phone Number: +90 533 225 38 56; Email: selda.celik@sbu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kadikoy
    • Istanbul, Kadikoy, Turkey (Türkiye)
      • Suleyman Yalcin City Hospital
      • Contact: ILKYAZ karahan, MSc, RN; Phone Number: +90 0530 060 49 05; Email: ilkyazkarahan97@gmail.com
      • Contact: ILKYAZ ÇELİK, MSc, RN; Phone Number: +90 533 225 38 56; Email: selda.celik@sbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group - Standard Care; 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.
Experimental: Intervention Group - Ignite-Based Medication Training; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence Report Scale	This scale is used to assess medication adherence. Total scores range from 5 to 25, with higher scores indicating better adherence and lower scores indicating poorer adherence.	5 minutes

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: ILKYAZ KARAHAN, MSc, RN, Hamidiye University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): November 25, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: education; nurse care; hearth failure; roy adaptation; digital presentation
• Other Study ID Numbers: E-46418926-050.04--539411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: "Participant privacy and confidentiality prevent sharing of individual-level data."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No