Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension

NCT07120789 | Recruiting

• 1 other identifier: SGP 27073
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

This methodological study aims to develop and validate a questionnaire named for the Assessment of Patient Knowledge in Pulmonary Arterial Hypertension. The study will be conducted in four phases: (1) questionnaire development based on guidelines and literature; (2) content validation by expert judges; (3) semantic validation with patients; and (4) psychometric testing in a sample of up to 200 patients with confirmed pulmonary arterial hypertension (PAH). In addition to validation, the study will collect clinical and functional data from medical records, including risk stratification using the COMPERA 2.0 method The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.

Conditions

Pulmonary Hypertension; Pulmonary Arterial Hypertension (PAH); Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Keywords

Pulmonary Hypertension; Patient Knowledge; Questionnaire Validation; Content Validity; Semantic Analysis; Psychometric Validation; Health Education; Patient Education; Chronic Disease

Outcome Measures

Primary Outcomes (3)

• Content Validity Index (CVI) of the Questionnaire Items

  Proportion of agreement among expert judges regarding the relevance and clarity of each item. Items with CVI ≥ 0.80 will be considered valid.

  4 weeks after expert panel review

• Semantic Clarity Rating by Patients

  Assessment of the clarity and comprehension of each item by patients using a structured form. Items with ≥ 85% of patients rating them as clear or very clear will be considered semantically valid.

  2 weeks after patient interview

• Internal Consistency of the Questionnaire (Cronbach's Alpha)

  Psychometric evaluation of the final version of the SAVOIR questionnaire using Cronbach's alpha. A coefficient ≥ 0.70 will be considered acceptable. The analysis will be conducted in a sample of up to 200 patients.

  4 weeks after questionnaire completion

Secondary Outcomes (6)

• Test-Retest Reliability (Intraclass Correlation Coefficient - ICC)

  2 weeks after first questionnaire administration

• Completion Rate and Acceptability of the Questionnaire

  At the time of first questionnaire administration (Day 1)

• 6. Association Between questionnaire Score and Risk Stratification (COMPERA 2.0)

  Within 4 weeks of questionnaire completion

• Association Between questionnaire Score and Number of PAH-related Hospitalizations

  Within 4 weeks of questionnaire completion

• Association Between the questionnaire Score (being developed) and Quality of Life Measures (EMPHASIS-10)

  Within 4 weeks of questionnaire completion

Study Arms (1)

Single Group

EXPERIMENTAL

Participants in this arm will take part in one of three phases of the questionnaire validation study: 1. content validation by expert judges, 2. semantic validation by patients with pulmonary arterial hypertension (PAH), 3. psychometric validation in a larger sample of up to 200 patients with confirmed PAH. In the psychometric phase, participants will complete the final version of the SAVOIR questionnaire. Additional clinical and functional data will be collected from medical records, including: risk stratification using the COMPERA 2.0 method, These data will be used to explore associations between patient knowledge and clinical/functional outcomes.

Other: Application of Patient Knowledge Questionnaire on Pulmonary Hypertension

Interventions

Application of Patient Knowledge Questionnaire on Pulmonary Hypertension OTHER

Participants will complete one version of the SAVOIR questionnaire, developed to assess patient knowledge about pulmonary arterial hypertension. Depending on the study phase, participants will contribute to content validation (expert judges), semantic validation (patients), or psychometric validation (patients). In the final phase, additional data including risk stratification (COMPERA 2.0) will be collected for correlational analysis.

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Confirmed diagnosis of Group 1 Pulmonary Arterial Hypertension (PAH)
• Ability to read and understand the questionnaire language
• Provided informed consent to participate in the study
• For expert judges (content validation phase): professionals with recognized expertise in pulmonary hypertension, with academic or clinical experience in the field

You may not qualify if:

• Cognitive, visual, or auditory impairments that hinder questionnaire comprehension
• Refusal to participate or withdrawal of informed consent
• Inability to complete the questionnaire due to clinical instability

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Health Education; Chronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caio Fernandes Principal Investigato, PhD

CONTACT

+55 11 2661 5034; caio.cesar@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied. This is an open-label, non-randomized methodological study to validate a questionnaire. All participants and investigators were aware of the intervention (questionnaire application).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a methodological study for the development and validation of a questionnaire. The model includes sequential phases: construction, content validation by expert judges, semantic validation with patients, and psychometric analysis in a cross-sectional design. During the final phase, clinical and functional data will be collected from medical records to assess associations between knowledge scores and patient outcomes such as risk stratification (COMPERA 2.0). The study does not involve any intervention or assignment of participants to treatment arms.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)