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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| ILKYAZ KARAHAN, MSc, RN | Hamidiye University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suleyman Yalcin City Hospital | Istanbul | Kadikoy | Turkey (Türkiye) |
"Participant privacy and confidentiality prevent sharing of individual-level data."
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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.
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