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

April 15, 2026 updated by: İlkyaz Karahan, Saglik Bilimleri Universitesi

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Failure Symptom Status Scale
Time Frame: 20 minutes
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication Adherence Report Scale
Time Frame: 5 minutes
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ILKYAZ KARAHAN, MSc, RN, Hamidiye University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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