Hearth Failure With Reduced Ejection Fraction (HFrEF)NCT07538596
Medication Training Via Ignite Based on Roy Model in Heart Failure: Medication Adherence and Symptom Management
A study testing Ignite-Based Medication Management Training in people with Hearth Failure With Reduced Ejection Fraction (HFrEF), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hearth Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Ignite-Based Medication Management Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Suleyman Yalcin City Hospital
Istanbul, Kadikoy
ILKYAZ karahan, MSc, RN, +90 0530 060 49 05, ilkyazkarahan97@gmail.com
ILKYAZ ÇELİK, MSc, RN, +90 533 225 38 56, selda.celik@sbu.edu.tr
About this study
Official 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
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:
Read more
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
Read the 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.
- Being tested
- Ignite-Based Medication Management Training
- Keywords
- hearth failure, roy adaptation, nurse care, digital presentation, education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ignite-Based Medication Management TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Ignite-Based Medication Management Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearth Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkyaz Karahan, Saglik Bilimleri Universitesi
- Investigators
- ILKYAZ KARAHAN, MSc, RN, Principal investigator, Hamidiye University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538596
- Sponsor's protocol ID
- E-46418926-050.04--539411
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Participant privacy and confidentiality prevent sharing of individual-level data."
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07538596
- Acronym / sponsor ID
- E-46418926-050.04--539411
- Keywords
- hearth failure, roy adaptation, nurse care, digital presentation, education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Ignite-Based Medication Management TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 .
Key exclusion criteria (4 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ignite-Based Medication Management TrainingThe 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. | Other | Intervention Group - Ignite-Based Medication Training |
Primary outcome
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.
1 secondary outcome
Medication Adherence Report Scale
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. "Participant privacy and confidentiality prevent sharing of individual-level data."
Related trials for Hearth Failure With Reduced Ejection Fraction (HFrEF)
Active, not recruitingObservational study
THE RELATIONSHIP BETWEEN CARDIAC RESYNCHRONİZATION THERAPY RESPONSE IN HEART FAILURE PATIENTS AND YKL-40 LEVELS
Hearth Failure With Reduced Ejection Fraction (HFrEF), Cardiac Resynchronisation Therapy (CRT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ILKYAZ KARAHAN, MSc, RN principal investigator
Hamidiye University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ignite-Based Medication Management Training in people with Hearth Failure With Reduced Ejection Fraction (HFrEF), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilkyaz karahan, MSc, RN (+90 0530 060 49 05, ilkyazkarahan97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Symptom Status Scale (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.