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NCT Number: NCT07538596

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

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

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Key information

Conditions

Hearth Failure With Reduced Ejection Fraction (HFrEF)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Selda ÇELİK, PhD, RN, Prof.

CONTACT

[email protected]

+90 533 225 38 56

ilkyaz karahan, MSc, RN

CONTACT

[email protected]

+90 0530 060 49 05

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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