Chronic Thromboembolic Pulmonary HypertensionCTEPH3NCT07272798
Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to analyze the effect of Pulmonary Endarterectomy (PEA) on patients' self-confidence in managing their chronic illness. Patients' confidence (or self-efficacy) will be measured using the following questionnaires: 10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI), Self-Efficacy… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- How many people
- 10 participants
- Where
- 1 siteSyria
- Study dates
- 20 Nov 2025to 20 Nov 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed with operable chronic pulmonary thromboembolic pulmonary hypertension undergoing pulmonary thromboendarterectomy
Who may be able to join
- all patients undergoing pulmonary thromboendarterectomy for CTEPH
- Able to read and understand the informed consent form and study questionnaires
Who cannot join
- Patients undergoing Balloon Pulmonary Angioplasty (BPA) or receiving only medical therapy (as the focus is on the surgical cohort).
- Emergency or salvage PEA procedures (to ensure stable baseline assessment).
- Inability to complete the questionnaires due to severe cognitive impairment, psychiatric illness, or language barrier.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site, 1 recruiting
- Recruiting
Damascus University Cardiac Surgery Hospital
Damascus, Rif-dimashq Governorate
Mohammad B Izzat, FRCS(CTh), +963933240820, mbizzat@gmail.com
Mohamad M Almouallem, MD, +963948376770, m.m.almouallem@gmail.com
About this study
This study aims to analyze the effect of Pulmonary Endarterectomy (PEA) on patients' self-confidence in managing their chronic illness.
Patients' confidence (or self-efficacy) will be measured using the following questionnaires: 10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI), Self-Efficacy for Managing Chronic Diseases 6-item Scale (SEMCD-6), Sullivan's cardiac self-efficacy scale 13-items (SCSES). The association between improved confidence and better physical results will be analyzed, such as being able to walk longer (6 mint walk test (6-Minute Walk Test)).
Ultimately, this study will help understanding the psychological side of recovery and might lead to better support programs to help patients feel more capable and live better lives after their operation.
Read the detailed description
This study specifically focuses on three key domains of self-efficacy relevant to the cardiac patient:
- Patient-Physician Interaction (PEPPI): Confidence in communication with healthcare providers, which is vital for navigating the complexity of post-operative care, medication management, and identifying emergent issues.
- Chronic Disease Management (SEMCD-6): Confidence in performing essential self-care tasks, such as managing symptoms, coping with emotional distress, and maintaining a healthy lifestyle.
- Sullivan's cardiac self-efficacy scale 13-items (SCSES): it focuses on two dimensions: controlling symptoms and maintaining daily function We hypothesize that the successful physical removal of the disease burden via PEA will act as a major "mastery experience," fundamentally boosting a patient's self-efficacy. This improvement is expected to be immediately following the clinical stabilization and persist during follow-up, facilitating better long-term outcomes.
Study Rationale and Novelty
Current literature on CTEPH and PEA is heavily focused on the physiological and hemodynamic aspects of the disease. There is a significant gap in the understanding of the patient-reported psychological factors that contribute to excellent outcomes. This prospective cohort study is unique because:
- It is the first, to our knowledge, to specifically and longitudinally quantify the change in cardiac self-efficacy in patients undergoing PEA.
- It directly links this psychological change to the objective measure of surgical success (change in 6MWT), addressing the secondary objective of determining the correlation between psychological and physiological improvement.
- By using Multiple Linear Regression, the study will identify specific pre-operative baseline factors (e.g., 6MWT) that may predict which patients are most likely to experience a significant post-operative self-efficacy gain or remain at risk for low self-efficacy. This has direct implications for identifying patients who would benefit most from targeted pre-operative psychological support or post-operative rehabilitation strategies.
Expected Impact The findings of this study will contribute significantly to the holistic management of CTEPH patients. If a robust correlation is found between the magnitude of self-efficacy change and improved clinical outcomes or reduced readmission rates, it will provide strong evidence to support the integration of self-efficacy-focused interventions into post-PEA cardiac rehabilitation programs. Ultimately, understanding and bolstering the patient's belief in their ability to manage their condition post-surgery will not only optimize the clinical gains achieved by the PEA but also enhance long-term quality of life and reduce the burden on the healthcare system.
- Keywords
- Chronic thromboembolic pulmonary hypertension, self efficacy, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CTEPH | Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI)
The scale measures patients perceived self-efficacy. It assesses how confident patients feel in their communication skills with doctors, including explaining health concerns and asking for more information. The scale consists of 10 items where patients rate their confidence on a scale typically from 1 (not at all confident) to 5 (very confident). The total score ranges from 10 to 50, with higher scores indicating higher perceived efficacy.
Measured: Preoperatively and 6 months postoperatively
Self-Efficacy for Managing Chronic Diseases 6-item Scale (SEMCD-6)
This scale measures an individual's confidence in their ability to manage tasks and challenges associated with chronic diseases. It assesses self-efficacy related to managing symptoms, treatment, and the impact of chronic diseases on daily life. The scale includes 6 items where individuals rate their confidence on a numerical scale, typically from 1 ("not at all confident") to 10 ("totally confident"). The responses are averaged to produce a final score. The mean score of the 6 items, ranging from 1 to 10, with higher scores indicating higher self-efficacy.
Measured: Preoperatively and 6 months postoperatively
Sullivan's cardiac self-efficacy scale 13-items (SCSES)
The SCSES measures a patient's confidence in their ability to manage cardiac-related symptoms and maintain daily functioning despite heart disease. The scale assesses cardiac-specific self-efficacy, including two dimensions - control of symptoms (8 items) and maintaining function (5 items). The scale consists of 13 items. Each item asks, "How confident are you that you know or can..." and is rated by patients from 0 ("not at all confident") to 4 ("completely confident"). The scores are summed for a total score. The total score is the sum of 13 items, ranging from 0 to 52, with higher scores indicating higher cardiac self-efficacy.
Measured: Preoperatively and 6 months postoperatively
The 6-minute walk test (6MWT)
The 6MWT measures the functional exercise capacity by assessing the distance a person can walk in six minutes. It evaluates submaximal aerobic capacity, endurance, and overall physical function, particularly useful in cardiopulmonary and chronic disease patients. The patient walks along a flat, straight corridor, ideally 30 meters in length, for 6 minutes. The total distance walked is measured in meters. The test uses a marked corridor with distance markers, a stopwatch, and optionally a pulse oximeter and blood pressure monitor to record physiological responses during the test. Unit of Measurement: Distance walked in meters over 6 minutes.
Measured: Preoperatively and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start20 Nov 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bashar Izzat, Damascus University
- Investigators
- Mohammad B Izzat, FRCS(CTh), Study director, Damascus University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272798
- Sponsor's protocol ID
- CTEPH3
- Acronym
- CTEPH3
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be deposited in the figshare repository
Publications
Kim NH, D'Armini AM, Delcroix M, Jais X, Jevnikar M, Madani MM, Matsubara H, Palazzini M, Wiedenroth CB, Simonneau G, Jenkins DP. Chronic thromboembolic pulmonary disease. Eur Respir J. 2024 Oct 31;64(4):2401294. doi: 10.1183/13993003.01294-2024. Print 2024 Oct.
PubMed 39209473Melin J, Fors A, Jakobsson S, Krabbe D, Bjorkman I. Self-Efficacy to Manage Chronic Disease (SEMCD) scale: translation and evaluation of measurement properties for a swedish version. Arch Public Health. 2023 Jan 4;81(1):2. doi: 10.1186/s13690-022-01022-x.
PubMed 36600298Dardi F, Rotunno M, Guarino D, Suarez SM, Niro F, Loforte A, Taglieri N, Ballerini A, Magnani I, Bertozzi R, Donato F, Martini G, Manes A, Saia F, Pacini D, Galie N, Palazzini M. Comparison of different treatment strategies in patients with chronic thromboembolic pulmonary hypertension: a single centre real-world experience. Int J Cardiol. 2023 Nov 15;391:131333. doi: 10.1016/j.ijcard.2023.131333. Epub 2023 Sep 4.
PubMed 37673403Fors A, Ulin K, Cliffordson C, Ekman I, Brink E. The Cardiac Self-Efficacy Scale, a useful tool with potential to evaluate person-centred care. Eur J Cardiovasc Nurs. 2015 Dec;14(6):536-43. doi: 10.1177/1474515114548622. Epub 2014 Aug 22.
PubMed 25149667Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
PubMed 9670878Raguragavan A, Jayabalan D, Dhakal S, Saxena A. A systematic review of the impact of pulmonary thromboendarterectomy on health-related quality of life. Pulm Circ. 2024 Jul 1;14(3):e12407. doi: 10.1002/pul2.12407. eCollection 2024 Jul.
PubMed 38962182
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07272798
- Acronym / sponsor ID
- CTEPH3 / CTEPH3
- Keywords
- Chronic thromboembolic pulmonary hypertension, self efficacy, functional capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to analyze the effect of Pulmonary Endarterectomy (PEA) on patients' self-confidence in managing their chronic illness.
Patients' confidence (or self-efficacy) will be measured using the following questionnaires: 10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI), Self-Efficacy for Managing Chronic Diseases 6-item Scale (SEMCD-6), Sullivan's cardiac self-efficacy scale 13-items (SCSES). The association between improved confidence and better physical results will be analyzed, such as being able to walk longer (6 mint walk test (6-Minute Walk Test)).
Ultimately, this study will help understanding the psychological side of recovery and might lead to better support programs to help patients feel more capable and live better lives after their operation.
Detailed description
This study specifically focuses on three key domains of self-efficacy relevant to the cardiac patient:
- Patient-Physician Interaction (PEPPI): Confidence in communication with healthcare providers, which is vital for navigating the complexity of post-operative care, medication management, and identifying emergent issues.
- Chronic Disease Management (SEMCD-6): Confidence in performing essential self-care tasks, such as managing symptoms, coping with emotional distress, and maintaining a healthy lifestyle.
- Sullivan's cardiac self-efficacy scale 13-items (SCSES): it focuses on two dimensions: controlling symptoms and maintaining daily function We hypothesize that the successful physical removal of the disease burden via PEA will act as a major "mastery experience," fundamentally boosting a patient's self-efficacy. This improvement is expected to be immediately following the clinical stabilization and persist during follow-up, facilitating better long-term outcomes.
Study Rationale and Novelty
Current literature on CTEPH and PEA is heavily focused on the physiological and hemodynamic aspects of the disease. There is a significant gap in the understanding of the patient-reported psychological factors that contribute to excellent outcomes. This prospective cohort study is unique because:
- It is the first, to our knowledge, to specifically and longitudinally quantify the change in cardiac self-efficacy in patients undergoing PEA.
- It directly links this psychological change to the objective measure of surgical success (change in 6MWT), addressing the secondary objective of determining the correlation between psychological and physiological improvement.
- By using Multiple Linear Regression, the study will identify specific pre-operative baseline factors (e.g., 6MWT) that may predict which patients are most likely to experience a significant post-operative self-efficacy gain or remain at risk for low self-efficacy. This has direct implications for identifying patients who would benefit most from targeted pre-operative psychological support or post-operative rehabilitation strategies.
Expected Impact The findings of this study will contribute significantly to the holistic management of CTEPH patients. If a robust correlation is found between the magnitude of self-efficacy change and improved clinical outcomes or reduced readmission rates, it will provide strong evidence to support the integration of self-efficacy-focused interventions into post-PEA cardiac rehabilitation programs. Ultimately, understanding and bolstering the patient's belief in their ability to manage their condition post-surgery will not only optimize the clinical gains achieved by the PEA but also enhance long-term quality of life and reduce the burden on the healthcare system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CTEPH | – | –Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with operable chronic pulmonary thromboembolic pulmonary hypertension undergoing pulmonary thromboendarterectomy
Key inclusion criteria (2 listed)
- all patients undergoing pulmonary thromboendarterectomy for CTEPH
- Able to read and understand the informed consent form and study questionnaires
Key exclusion criteria (3 listed)
- Patients undergoing Balloon Pulmonary Angioplasty (BPA) or receiving only medical therapy (as the focus is on the surgical cohort).
- Emergency or salvage PEA procedures (to ensure stable baseline assessment).
- Inability to complete the questionnaires due to severe cognitive impairment, psychiatric illness, or language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI)
Time frame: Preoperatively and 6 months postoperatively
The scale measures patients perceived self-efficacy. It assesses how confident patients feel in their communication skills with doctors, including explaining health concerns and asking for more information. The scale consists of 10 items where patients rate their confidence on a scale typically from 1 (not at all confident) to 5 (very confident). The total score ranges from 10 to 50, with higher scores indicating higher perceived efficacy.
Self-Efficacy for Managing Chronic Diseases 6-item Scale (SEMCD-6)
Time frame: Preoperatively and 6 months postoperatively
This scale measures an individual's confidence in their ability to manage tasks and challenges associated with chronic diseases. It assesses self-efficacy related to managing symptoms, treatment, and the impact of chronic diseases on daily life. The scale includes 6 items where individuals rate their confidence on a numerical scale, typically from 1 ("not at all confident") to 10 ("totally confident"). The responses are averaged to produce a final score. The mean score of the 6 items, ranging from 1 to 10, with higher scores indicating higher self-efficacy.
Sullivan's cardiac self-efficacy scale 13-items (SCSES)
Time frame: Preoperatively and 6 months postoperatively
The SCSES measures a patient's confidence in their ability to manage cardiac-related symptoms and maintain daily functioning despite heart disease. The scale assesses cardiac-specific self-efficacy, including two dimensions - control of symptoms (8 items) and maintaining function (5 items). The scale consists of 13 items. Each item asks, "How confident are you that you know or can..." and is rated by patients from 0 ("not at all confident") to 4 ("completely confident"). The scores are summed for a total score. The total score is the sum of 13 items, ranging from 0 to 52, with higher scores indicating higher cardiac self-efficacy.
The 6-minute walk test (6MWT)
Time frame: Preoperatively and 6 months postoperatively
The 6MWT measures the functional exercise capacity by assessing the distance a person can walk in six minutes. It evaluates submaximal aerobic capacity, endurance, and overall physical function, particularly useful in cardiopulmonary and chronic disease patients. The patient walks along a flat, straight corridor, ideally 30 meters in length, for 6 minutes. The total distance walked is measured in meters. The test uses a marked corridor with distance markers, a stopwatch, and optionally a pulse oximeter and blood pressure monitor to record physiological responses during the test. Unit of Measurement: Distance walked in meters over 6 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 39209473Kim NH, D'Armini AM, Delcroix M, Jais X, Jevnikar M, Madani MM, Matsubara H, Palazzini M, Wiedenroth CB, Simonneau G, Jenkins DP. Chronic thromboembolic pulmonary disease. Eur Respir J. 2024 Oct 31;64(4):2401294. doi: 10.1183/13993003.01294-2024. Print 2024 Oct.
- Background: PubMed 36600298Melin J, Fors A, Jakobsson S, Krabbe D, Bjorkman I. Self-Efficacy to Manage Chronic Disease (SEMCD) scale: translation and evaluation of measurement properties for a swedish version. Arch Public Health. 2023 Jan 4;81(1):2. doi: 10.1186/s13690-022-01022-x.
- Background: PubMed 37673403Dardi F, Rotunno M, Guarino D, Suarez SM, Niro F, Loforte A, Taglieri N, Ballerini A, Magnani I, Bertozzi R, Donato F, Martini G, Manes A, Saia F, Pacini D, Galie N, Palazzini M. Comparison of different treatment strategies in patients with chronic thromboembolic pulmonary hypertension: a single centre real-world experience. Int J Cardiol. 2023 Nov 15;391:131333. doi: 10.1016/j.ijcard.2023.131333. Epub 2023 Sep 4.
- Background: PubMed 25149667Fors A, Ulin K, Cliffordson C, Ekman I, Brink E. The Cardiac Self-Efficacy Scale, a useful tool with potential to evaluate person-centred care. Eur J Cardiovasc Nurs. 2015 Dec;14(6):536-43. doi: 10.1177/1474515114548622. Epub 2014 Aug 22.
- Background: PubMed 9670878Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
- Background: PubMed 38962182Raguragavan A, Jayabalan D, Dhakal S, Saxena A. A systematic review of the impact of pulmonary thromboendarterectomy on health-related quality of life. Pulm Circ. 2024 Jul 1;14(3):e12407. doi: 10.1002/pul2.12407. eCollection 2024 Jul.
- Individual participant dataSharing planned: Yes. Data will be deposited in the figshare repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad B Izzat, FRCS(CTh) study director
Damascus University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Damascus University at 1 site in Syria.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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 Syria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad M Almouallem, MD (+963948376770, m.m.almouallem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI) (time frame: Preoperatively and 6 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07272798, which also lists 6 linked publications.
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 17 Dec 2025.