Quality of Life Assessed With the PAH SYMPACT Questionnaire

Quality of Life Assessed With the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic

Researchers are evaluating quality of life in pulmonary hypertension subjects using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire and assessing the questionnaires' performance with regard to relationship to other markers of disease severity, response to treatment, and outcome in a clinical practice setting.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension

Detailed Description

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic. The PAH-SYMPACT questionnaire will be administered either in written form or by telephone interview.

On the second 100 patients implement a standardized palliative care referral program for patients with Group 1 and 3 PH and high SYMPACT scores> 1.0.

• Study Type: Observational
• Enrollment (Actual): 390

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from among those seen at the Mayo Pulmonary Hypertension Clinic.

Description

Inclusion Criteria:

• Age 18 years or above
• Consents to participate
• Documented group I PAH based upon these hemodynamic criteria: (mPAP > 20, PCW 18 or less, PVR > 3 Wood units
• Mean PAP > 20, PCW ≤ 18, PVR > 3 Wood units
• Parenchymal lung disease that in the opinion of the investigator qualifies patient as group III PH
• Documented chronic thromboembolic pulmonary hypertension or chronic thromboembolic disease with intent to treat with surgery, balloon pulmonary angioplasty, and/or PH medication

Exclusion Criteria:

• Left sided heart disease (LVEF<50%, PAWP>18)
• Any other known concomitant life-threatening disease with a life expectancy <12 months
• Any other clinically relevant and/or serious chronic medical condition that would affect study participation in the opinion of the investigator
• Non English speaking

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
usual care; The patient will be seen in the PH clinic and will be approached to consent and participate in the SYMPACT trial. They will not be randomized to palliative care.
palliative care; The patient will be seen in the PH clinic and will be approached to consent and participate in the SYMPACT trial. Based on the patients in Group 1 and 3 PH and a high SYMPACT score> 1.0 in any domain they will be randomized to receive standard care or a palliative care initial consult.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life in pulmonary hypertension subjects	Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire using a scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe	Baseline
Quality of life in pulmonary hypertension subjects	Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire using a scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe	14 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Hilary M DuBrock, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 19-000630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No