Dynamic Mixed Learning Module in Pulmonary Hypertension Patients

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.

• 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.

Primary outcomes

• EmPHasis-10 Questionnaire [Start of study , 3 months, 6 months, and 9 months]: 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.

Secondary outcomes

• Hospital Anxiety and Depression Scale (HADS) [Study start, 3 months, 6 months, and 9 months]: 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.
• 6-Minute Walk Test, 6MWT [Study start, 3 months, 6 months, and 9 months]: 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%.
• Modified Borg Dyspnea Scale [Study start, 3 months, 6 months, and 9 months]: 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.
• Richards-Campbell Sleep Questionnaire (RCSQ) [Study start, 3 months, 6 months, and 9 months]: 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.
• Verbal Rating Scale (VRS) [Study start, 3 months, 6 months, and 9 months]: 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.

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

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

• Fatma Yıldırım, Msc, Principal investigator, Acibadem Universty