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Pulmonary HypertensionLearningNCT07429552

Dynamic Mixed Learning Module in Pulmonary Hypertension Patients

A study testing Symptom Management in people with Pulmonary Hypertension and Nursing Care, run by Acibadem University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Pulmonary Hypertension, Nursing Care, Learning
What is being tested?
Symptom Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Jan 2022to 27 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Provincial Directorate of Health

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Symptom Management
Keywords
Symptom Management, Pulmonary Hypertension, Dynamic Mixed Learning
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Symptom ManagementOther

    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.

Study groups in NCT07429552
Study groupRoleWhat they receive
Arm1ExperimentalIn 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.
Receives: Other: Symptom Management
Arm2No interventionNo intervention was performed on the patients. Follow-ups were conducted according to the hospital's standard care protocols.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Start of study , 3 months, 6 months, and 9 months

Secondary outcomes (5)
  1. 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.

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

  2. 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%.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2026
  2. Study start3 Jan 2022
  3. Primary completion27 Dec 2023
  4. Study completion27 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07429552
Sponsor's protocol ID
ATADEK2021-14/44
Acronym
Learning
Status last verified
Feb 2026
First submitted
14 Aug 2025
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Symptom Management in people with Pulmonary Hypertension and Nursing Care, run by Acibadem University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EmPHasis-10 Questionnaire (time frame: Start of study , 3 months, 6 months, and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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