Dynamic Mixed Learning Module in Pulmonary Hypertension Patients

NCT07429552 | Completed DMC

• 1 other identifier: ATADEK2021-14/44
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension; Nursing Care; Learning

Keywords

Symptom Management; Pulmonary Hypertension; Dynamic Mixed Learning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS)

  Study start, 3 months, 6 months, and 9 months

• 6-Minute Walk Test, 6MWT

  Study start, 3 months, 6 months, and 9 months

• Modified Borg Dyspnea Scale

  Study start, 3 months, 6 months, and 9 months

• Richards-Campbell Sleep Questionnaire (RCSQ)

  Study start, 3 months, 6 months, and 9 months

• Verbal Rating Scale (VRS)

  Study start, 3 months, 6 months, and 9 months

Study Arms (2)

Arm1

EXPERIMENTAL

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

Arm2

NO INTERVENTION

No intervention was performed on the patients. Follow-ups were conducted according to the hospital's standard care protocols.

Interventions

Symptom Management OTHER

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.

Arm1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Provincial Directorate of Health

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatma Yıldırım, Msc

  Acibadem Universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was conducted after official approvals were obtained. The sample was assigned to intervention and control groups using stratified randomization based on age, sex, and PH classification. The intervention group received the Dynamic Blended Education Module (DBEM), while the control group received standard outpatient education. All participants completed the planned education and follow-up processes.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: February 24, 2026
• Study Start: January 3, 2022
• Primary Completion: December 27, 2023
• Study Completion: June 27, 2024
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)