NCT03146702

Brief Summary

Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in mean pulmonary artery pressure ≥25 mmHg when measured at rest. PH often progresses to heart failure and premature deaths. PH is a progressive disease that has many causes, which can affect people of all ages, is characterized by shortness of breath, reduced exercise tolerance, psychological distress and tiredness and reduced quality of life. Surveys of SF-36, 'Nottingham Health Profiles' and 'Minnesota Life with Heart Failure' surveys are routinely performed in PH clinically. However, none of the questionnaires are specific to pulmonary hypertension, so they are incomplete in determining the condition of the disease and the patients. There is no Turkish questionnaire for patients with pulmonary hypertension and other surveys used are inadequate in determining the condition of the patient and the patient since they are not specific to the disease. The aim is to provide a Turkish questionnaire that is specific to pulmonary hypertension in the literature.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 20, 2018

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

May 8, 2017

Last Update Submit

February 18, 2018

Conditions

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (2)

  • Validity

    Validity of EmPHasis-10 Questionnaire

    8 months

  • Reliability

    Reliability of EmPHasis-10 Questionnaire

    8 months

Interventions

Patients self administor quality of life questionnaires such as Minnesota Living with Heart Failure Questionnaire and EmPHasis-10 questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Investigators include Pulmonary Hypertension patients who is following at least 6 months by the pulmonary hypertension policlinic. Patients had to be native turkish to newly translated EmPHasis-10 questionnaire to be valid. Patients who have cognitive impairment and difficulty understanding or speaking Turkish are excluded.

You may qualify if:

  • Have been diagnosed with Pulmonary Hypertension
  • Following at least 6 months of Pulmonary Hypertension policlinic
  • Native Turkish
  • People age 18 years or older

You may not qualify if:

  • Those with cognitive impairment
  • Those who have difficulty understanding or speaking Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Pınar Odevoglu, MSc

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc, Research Assistant

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

February 20, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations