Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension
NCT ID: NCT07272798
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
10 participants
OBSERVATIONAL
2025-11-20
2026-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
3. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with CTEPH
Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to read and understand the informed consent form and study questionnaires
Exclusion Criteria
* 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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damascus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammad Bashar Izzat
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohammad B Izzat, FRCS(CTh)
Role: STUDY_DIRECTOR
Damascus University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Damascus University Cardiac Surgery Hospital
Damascus, Damascus, Syria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Fors 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.
Maly 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.
Raguragavan 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.
Blechman EA, Maurice A, Buecker B, Helberg C. Can mentoring or skill training reduce recidivism? Observational study with propensity analysis. Prev Sci. 2000 Sep;1(3):139-55. doi: 10.1023/a:1010073222476.
Andrew CM. Optimizing the human experience: nursing the families of people who die in intensive care. Intensive Crit Care Nurs. 1998 Apr;14(2):59-65. doi: 10.1016/s0964-3397(98)80184-5.
Dardi 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTEPH3
Identifier Type: -
Identifier Source: org_study_id