NCT07429552

Dynamic Mixed Learning Module in Pulmonary Hypertension Patients

The Effect of a Dynamic Blended Learning Module on Symptom Management in Patients Diagnosed With Pulmonary Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study was conducted to evaluate the effect of the Dynamic Blended Learning Module developed for patients diagnosed with pulmonary hypertension (PH) on symptom management. Pulmonary hypertension is a chronic disease that can cause symptoms that make daily life difficult, such as shortness of breath, fatigue, chest pain, dizziness, fainting, anxiety, body pain, edema, and sleep problems. These symptoms can negatively affect patients' daily lives and treatment process. This study examined whether a structured program involving education and regular follow-up helped patients better manage their symptoms. As part of the program, patients received face-to-face education and regular phone calls were made throughout the nine-month follow-up period. The education sessions provided information about the course of the disease, the correct use of medications, and possible side effects. Patients were instructed on how to manage side effects such as muscle and jaw pain, facial redness, nausea, and abdominal bloating. Additionally, they were informed about when and how to contact the healthcare team if any issues arose. In one part of the program, a video showing the experiences of a patient who effectively managed their illness was shown to participants in the intervention group. Patients were monitored for nine months and their symptoms were assessed at regular intervals. The program's effect on symptom management was evaluated by comparing it with patients receiving standard care.

Detailed description

This study evaluated the effects of the Dynamic Blended Education Module (DBEM) on symptom management in patients diagnosed with pulmonary hypertension (PH). The study aimed to improve participants' ability to manage core PH symptoms-including dyspnea, chest pain, syncope, fatigue/weakness, anxiety/worry, edema, pain, and nausea-vomiting-both due to the disease process and the side effects of medications used. Written informed consent was obtained from all participants prior to enrollment. The sample size was calculated using the G\*Power program. An expected effect size of d=0.4 for the intervention group was considered, and it was determined that a total of 46 patients were required to achieve 85% power and a 5% alpha error. Initially, 46 patients were enrolled and assigned via stratified randomization by age, sex, and PH classification into the intervention (n=23) and control (n=23) groups. Baseline assessments included the Patient Identification Data Form, as well as validated and reliable instruments: EmPHasis-10 Scale, Hospital Anxiety and Depression Scale (HAD), and Richards-Campbell Sleep Questionnaire (RCUQ). Functional capacity was assessed using the Modified Borg Dyspnea Scale, Verbal Category Scale, and 6-Minute Walk Test (6MWT). Patients rested for 10 minutes before the 6MWT. At the start of the test, dyspnea, blood pressure, heart rate, and oxygen saturation were recorded. Participants walked for 6 minutes along a 30-meter corridor at their usual walking pace, with rest breaks as needed. The total walking distance was recorded, and symptoms were monitored during the test. At the end of the test, distance walked was calculated, and dyspnea, blood pressure, heart rate, and oxygen saturation were re-measured. In the intervention group, symptom management was monitored by telephone during the first month. In the third month, the first intervention, which included face-to-face symptom management training during outpatient visits, was performed. This training covered the recognition and daily management of symptoms such as shortness of breath, chest pain, syncope, fatigue/weakness, anxiety/worry, edema, pain, and nausea-vomiting. After the initial intervention, 2 patients were excluded (ex), and new patients were enrolled according to randomization and inclusion criteria to maintain the sample size. Telephone follow-up continued between the 3rd and 6th months to monitor treatment adherence and symptom management. In the sixth month, an educational video describing the experience of a patient who effectively managed their own symptoms was shown face-to-face during outpatient visits, and peer support was provided to participants to facilitate symptom management; follow-up of patients continued by telephone between the 6th and 9th months, and data analysis was completed by repeating the outcome assessments in the 9th month. All participants completed the planned education and follow-up processes in both the intervention and control groups. In the control group, assessment tools were administered at baseline and at 3-, 6-, and 9-month intervals during routine outpatient visits conducted every three months. During these visits, physicians administered standard hospital training. Four patients were excluded from the control group (3 patients died, 1 patient was excluded due to imprisonment); new patients were enrolled according to randomization and inclusion criteria to maintain the sample size. These patient movements were recorded in the CONSORT flow chart. DBEM was a patient-centered and symptom-focused program designed to support patients in effectively managing their symptoms in daily life. Through personalized education, telephone follow-up, and experienced patient processes, the program aimed to improve treatment adherence and strengthen self-care skills.

Conditions

• Pulmonary Hypertension
• Nursing Care
• Learning

Interventions

Type	Name	Description
OTHER	Symptom Management	This study was conducted to evaluate the effectiveness of education and expert patient experience in symptom management. In the intervention group, the symptoms experienced by each patient were identified and addressed using a Dynamic Blended Education Module (DBEM). This included individualized education, telephone follow-up to monitor and support process management, and an educational video presenting the experiences of a patient who effectively managed their own symptoms. The video content was shared with participants to facilitate symptom management. Follow-ups and outcome assessments were conducted at 3, 6, and 9 months, aligned with routine outpatient visits. In the control group, only standard hospital protocols were applied, and results were compared between the two groups.

Timeline

• Start date: 2022-01-03
• Primary completion: 2023-12-27
• Completion: 2024-06-27
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)