Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension

NCT07272798 | Recruiting

• 1 other identifier: CTEPH3
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic thromboembolic pulmonary hypertension; self efficacy; functional capacity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Preoperatively and 6 months postoperatively

Study Arms (1)

Patients with CTEPH

Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University Cardiac Surgery Hospital

Damascus, Rif-dimashq Governorate, Syria

RECRUITING

Related Publications (6)

• 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.

  PMID: 39209473 BACKGROUND

• Melin 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.

  PMID: 36600298 BACKGROUND

• 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.

  PMID: 37673403 BACKGROUND

• 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.

  PMID: 25149667 BACKGROUND

• 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.

  PMID: 9670878 BACKGROUND

• 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.

  PMID: 38962182 BACKGROUND

Study Officials

• Mohammad B Izzat, FRCS(CTh)

  Damascus University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Mohamad M Almouallem, MD

CONTACT

+963948376770; m.m.almouallem@gmail.com

Mohammad B Izzat, FRCS(CTh)

CONTACT

+963933240820; mbizzat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be deposited upon completion of study and will be made available permanently
• Access Criteria: Open to all

Locations

SY (1)