Cardiac Self-Efficacy in Patients With Chronic Thromboemb... | NCT07272798

NCT07272798

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Label	Type	Description	Intervention Names
Patients with CTEPH		Patients who are diagnosed with chronic thromboembolic pulmonary hypertension who are eligible for surgical pulmonary thromboendarterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Mohamad M Almouallem, MD	Contact	+963948376770		m.m.almouallem@gmail.com
Mohammad B Izzat, FRCS(CTh)	Contact	+963933240820		mbizzat@gmail.com

Name	Affiliation	Role
Mohammad B Izzat, FRCS(CTh)	Damascus University School of Medicine	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Damascus University Cardiac Surgery Hospital	Recruiting	Damascus	Rif-dimashq Governorate		Syria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39209473	Background	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.
36600298	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.

IPD Sharing Statement Module

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.