ClinicalTrials.gg
RecruitingNCT07272798CTEPH3Updated Dec 17, 2025

Cardiac Self-Efficacy in Patients With Chronic Thromboembolic Pulmonary Hypertension

An observational study in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Damascus University. Recruiting at 1 site in Syria. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Damascus University · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Thromboembolic Pulmonary Hypertension

Keywords

  • Chronic thromboembolic pulmonary hypertension
  • self efficacy
  • functional capacity
03

In context

Hypertension, Pulmonary

1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.

This study's planned enrollment of 10 is below the median of 110 across 381 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Patients with CTEPH

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperatively and 6 months postoperatively

  2. 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.

    Time frame: Preoperatively and 6 months postoperatively

  3. 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.

    Time frame: Preoperatively and 6 months postoperatively

  4. 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.

    Time frame: Preoperatively and 6 months postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 39209473 ↗
  • 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. PubMed 36600298 ↗
  • 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. PubMed 37673403 ↗
  • 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. PubMed 25149667 ↗
  • 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. PubMed 9670878 ↗
  • 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. PubMed 38962182 ↗

Individual participant data

Plan to share: Yes — Data will be deposited in the figshare repository

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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

Access criteria: Open to all

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.

Of 143 non-industry observational studies under Hypertension, Pulmonary, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 167. This study's planned 12 months is below that.

Counting every sponsor, half of 168 studies reached it within 59 months; a quarter within 24 and three quarters within 107.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2025
First posted
Dec 9, 2025
StartActual
Nov 20, 2025
Primary completionEst.
Nov 20, 2026
CompletionEst.
Nov 20, 2026
Last update
Dec 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07272798
Responsible party
Mohammad Bashar Izzat (Professor, Damascus University) — Principal investigator
First posted
Dec 9, 2025
Start date
Nov 20, 2025
Primary completion
Nov 20, 2026 (estimated)
Completion
Nov 20, 2026 (estimated)
Last update
Dec 17, 2025

Study contacts

Mohamad M Almouallem, MD
Contact
m.m.almouallem@gmail.com
+963948376770
Mohammad B Izzat, FRCS(CTh)
Contact
mbizzat@gmail.com
+963933240820
Mohammad B Izzat, FRCS(CTh)
study director · Damascus University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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