Validation of a Patient Knowledge Questionnaire for Pulmonary Hypertension

NCT ID: NCT07120789

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-05-31

Brief Summary

This methodological study aims to develop and validate a questionnaire named DICTA (Questionnaire 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, number of hospitalizations, and quality of life scores assessed by CAMPHOR, SF-36, and MBG. The study will analyze the relationship between patient knowledge (as measured by DICTA) and these outcomes. The final instrument is expected to support patient education strategies and contribute to improved clinical management of PAH.

Detailed Description

This is a methodological study with a quantitative approach, developed in four main phases, aimed at constructing and validating a questionnaire to assess the knowledge of patients with pulmonary arterial hypertension (PAH). The study will be conducted at a reference outpatient center in Brazil and will follow established methodological guidelines for the development and validation of health-related instruments.

Phase 1 - Questionnaire Development:

The initial version of the questionnaire, named DICTA, will be created based on the 2022 ESC/ERS Guidelines for PAH, a review of the scientific literature on patient knowledge in chronic diseases, and validated instruments in other conditions (e.g., chronic kidney disease, inflammatory bowel disease, rheumatoid arthritis). Items will cover the following domains: basic concepts, signs and symptoms, diagnosis and exams, available treatments and their mechanisms, adherence and self-care, and side effect management. Items will be multiple-choice with the option "I don't know".

Phase 2 - Content Validation:

At least five expert judges with experience in PAH, health education, and instrument development will evaluate each item for clarity, relevance, representativeness, and appropriateness using a 4-point Likert scale. The Content Validity Index (CVI) will be calculated for each item (I-CVI) and for the total instrument (S-CVI). Items with I-CVI ≥ 0.78 will be retained.

Phase 3 - Semantic Validation:

A sample of at least 10 patients diagnosed with PAH will be asked to complete the questionnaire while verbalizing their understanding ("think-aloud" technique). Revisions will be made based on participant feedback to ensure clarity and comprehension.

Phase 4 - Pilot Study and Psychometric Analysis:

The refined DICTA questionnaire will be applied to a sample of up to 200 patients with confirmed PAH. Psychometric analysis will include internal consistency (Cronbach's alpha) and, if applicable, test-retest reliability (intraclass correlation coefficient - ICC). Exploratory factor analysis may be used to assess internal structure.

In addition to validation, the study will collect clinical and functional data from medical records, including:

Risk stratification using COMPERA 2.0 methodology

Number of hospitalizations related to PAH

Quality of life scores measured by:

CAMPHOR (Cambridge Pulmonary Hypertension Outcome Review)

SF-36 (Short Form Health Survey)

MBG (Medida de Bem-Estar Global)

The relationship between knowledge scores (DICTA) and these outcomes will be analyzed, aiming to explore whether higher patient knowledge is associated with better risk status, lower hospitalization rates, and higher quality of life.

This instrument is expected to help identify educational gaps, support targeted health education strategies, and contribute to improved clinical outcomes and shared decision-making in the care of PAH patients.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Single Group

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 DICTA questionnaire. Additional clinical and functional data will be collected from medical records, including:

risk stratification using the COMPERA 2.0 method, number of PAH-related hospitalizations, and quality of life scores measured by the CAMPHOR (Cambridge Pulmonary Hypertension Outcome Review), SF-36 (Short Form Health Survey), and MBG (Global Well-Being Measure).

These data will be used to explore associations between patient knowledge and clinical/functional outcomes.

Group Type: EXPERIMENTAL

Application of Patient Knowledge Questionnaire on Pulmonary Hypertension

Intervention Type: OTHER

Participants will complete one version of the DICTA 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), hospitalizations, and quality of life scores (CAMPHOR, SF-36, MBG) will be collected for correlational analysis.

Interventions

Application of Patient Knowledge Questionnaire on Pulmonary Hypertension

Participants will complete one version of the DICTA 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), hospitalizations, and quality of life scores (CAMPHOR, SF-36, MBG) will be collected for correlational analysis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Caio Júlio César dos Santos Fernandes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Caio Fernandes Principal Investigato, PhD

Role: CONTACT

caio.cesar@hc.fm.usp.br

+55 11 2661 5034

Facility Contacts

Caio Fernandes, PhD

Role: primary

caio.cesar@hc.fm.usp.br

+55 11 2661 5034

Other Identifiers

SGP 27073

Identifier Type: -

Identifier Source: org_study_id