Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH3)

December 9, 2025 updated by: Mohammad Bashar Izzat, Damascus University

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study specifically focuses on three key domains of self-efficacy relevant to the cardiac patient:

  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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammad B Izzat, FRCS(CTh)
  • Phone Number: +963933240820
  • Email: mbizzat@gmail.com

Study Locations

  • Syria
    • Damascus
      • Damascus, Damascus, Syria
        • Recruiting
        • Damascus University Cardiac Surgery Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohamad M Almouallem, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with operable chronic pulmonary thromboembolic pulmonary hypertension undergoing pulmonary thromboendarterectomy

Description

Inclusion Criteria:

  • all patients undergoing pulmonary thromboendarterectomy for CTEPH
  • Able to read and understand the informed consent form and study questionnaires

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with CTEPH
Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively and 6 months postoperatively
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.
Preoperatively and 6 months postoperatively
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.
Preoperatively and 6 months postoperatively
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.
Preoperatively and 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Director: Mohammad B Izzat, FRCS(CTh), Damascus University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2025

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

November 20, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTEPH3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be deposited in the figshare repository

IPD Sharing Time Frame

Data will be deposited upon completion of study and will be made available permanently

IPD Sharing Access Criteria

Open to all

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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