Dynamic Mixed Learning Module in Pulmonary Hypertension Patients (Learning)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension; Learning; Nursing Care
• Intervention / Treatment: Other: Symptom Management

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Provincial Directorate of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Diagnosis of pulmonary hypertension.
• Functional class I-IV.
• Confirmed diagnosis of pulmonary hypertension for at least 6 months.
• Native Turkish speaker.
• Age ≥18 years
• Voluntary willingness to participate in the study

Exclusion Criteria:

• Individuals with cognitive impairments or communication difficulties that would interfere with study participation
• Patients who have previously undergone pulmonary endarterectomy and currently exhibit normal pulmonary artery pressures
• Individuals who decline to provide informed consent for participation
• Patients with an unstable or acute clinical condition

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm1; In the experimental group, the symptoms experienced by each patient were identified, and the Dynamic Mixed Education Module (DBEM) was implemented to support effective symptom management. Process monitoring and support were provided via telephone calls. An educational video was recorded sharing the experiences and management strategies of a patient who effectively managed their process, and this was shared with participants to support symptom management processes. Training sessions and outcome assessments were conducted at 3, 6, and 9 months, consistent with patients' routine outpatient visits.	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.
No Intervention: Arm2; No intervention was performed on the patients. Follow-ups were conducted according to the hospital's standard care protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EmPHasis-10 Questionnaire	Quality of life was assessed using the EmPHasis-10 Questionnaire, a disease-specific tool developed for patients with pulmonary hypertension. The questionnaire has a score range of 0-50, with higher scores indicating worse quality of life and lower scores indicating better quality of life.	Start of study , 3 months, 6 months, and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression symptoms were assessed using the Anxiety and Depression subscales of the 14-item Hospital Anxiety and Depression Scale (HADS). Each subscale is scored from 0 to 21. A cut-off score of 7/8 was used for the Anxiety subscale, and 10/11 for the Depression subscale. Scores above these thresholds indicate clinically significant anxiety or depression, respectively.	Study start, 3 months, 6 months, and 9 months
6-Minute Walk Test, 6MWT	Participants' functional capacities were assessed using the 6-Minute Walk Test (6MWT) conducted according to the American Thoracic Society (ATS) guidelines. Before the test, participants rested for 10 minutes while seated. Their dyspnea levels were assessed using the Borg scale (0-10); higher scores indicated more severe symptoms. Blood pressure and oxygen saturation were recorded before the test. Participants then walked at their normal pace for six minutes in a 30-meter corridor, and their rest periods were recorded. The total distance walked (in meters) was recorded, and threshold distances were set at 165 m and 440 m. Post-test breathlessness was reassessed using the Borg scale (0-10), and blood pressure and oxygen saturation were measured again. Contraindications for performing the test included a resting heart rate above 120 beats per minute, blood pressure above 180/100 mmHg, and oxygen saturation below 88%.	Study start, 3 months, 6 months, and 9 months
Modified Borg Dyspnea Scale	Dyspnea severity was assessed using the Modified Borg Dyspnea Scale. Scores range from 0 to 10, with higher scores indicating more severe dyspnea and lower scores indicating milder dyspnea.	Study start, 3 months, 6 months, and 9 months
Richards-Campbell Sleep Questionnaire (RCSQ)	Sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), which consisted of five items: sleep onset latency, sleep depth, frequency of awakenings, ease of returning to sleep, and overall sleep quality. Each item was scored from 0 to 100, with higher scores indicating better sleep quality and lower scores indicating poorer sleep quality.	Study start, 3 months, 6 months, and 9 months
Verbal Rating Scale (VRS)	Pain intensity was assessed using the Verbal Rating Scale (VRS). The scale ranged from 0 to 10 and was divided into four categories: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain. Participants selected the category that best described their current pain level.	Study start, 3 months, 6 months, and 9 months

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Principal Investigator: Fatma Yıldırım, Msc, Acibadem Universty

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): June 27, 2024

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pulmonary Hypertension; Symptom Management; Dynamic Mixed Learning
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: ATADEK2021-14/44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No