Survey on pulmonary hypertension patients' QOL

JRCT ID: jRCT1050230104

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary arterial hypertension(PAH) and Chronic thromboembolic pulmonary hypertension(CTEPH)
• Date of first enrollment: 27/09/2023
• Target sample size: 400
• Study type: Observational

Outcome(s)

Primary Outcome

emPHasis-10 (to assess HRQoL)
12-item Medication Adherence Scale (to assess drug adherence )

Secondary Outcome

The comparison of the goals and desires of treatment according to the characteristics of patients and physicians (for example, localization, severity of PAH/CTEPH, differences between PAH centers and general hospitals)
The comparison of response or total scores between patients and physicians
The differences in expectations and goals of PAH/CTEPH treatment for physicians and patients at the time of diagnosis and during treatment
The current preference and satisfaction of patients/physicians regarding PAH/CTEPH treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

For patients criteria:
The participating patient association and physician will evaluate patients' eligibility for data collection in the study using specified selection criteria. Any queries regarding these criteria should be discussed with the appropriate sponsor representative before survey distribution.
1.Patients are male or female aged 20 to 100 years of age, inclusive
2.Patients must have a confirmed diagnosis of PAH or CTEPH
3.Before participating in the survey, the participant must read and acknowledge the consent form that permits data collection according to the requirements of the participant's region. By agreeing to the consent form and completing the survey, participants are indicating their consent to the data collection process.

For doctors criteria:
In order to minimize bias in physician selection, the survey will be conducted using a panel owned by a specialized survey company where physicians are listed. To collect opinions from specialists in the rare diseases PAH and CTEPH, responses will also be requested from advisory physicians of the PH Patient Association.
1.Doctors who see at least one patient with pulmonary hypertension per month at their facility
2Before participating in the survey, participants must read and acknowledge a consent form that permits data collection in accordance with local requirements. By agreeing to the consent form and completing the survey, participants are indicating their consent to the data collection process.

Exclude criteria

For patients:
1.Minors (under 20 years of age)
2.Patients who are unable to understand the material provided
3.Patients who have never been diagnosed or treated for PAH/CTEPH by a physician in the past
4.Patients who did not properly answer the questions provided in the questionnaire

For doctors:
1.Doctors who have not responded appropriately to the questions listed on the questionnaire forms

Related Information

• Primary Sponsor: Omura Junichi