Qualitative Research to Explore Treatment Preference in Pulmonary Arterial Hypertension (PAH) Subjects

Qualitative Research to Explore Patient Preference for Modes of Administration in Pulmonary Arterial Hypertension Treatments

GlaxoSmithKline (GSK) is embarking on a clinical program to assess the treatment of PAH with an Angiotensin converting enzyme 2 (ACE2). This new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. Hence, GSK would like to conduct this qualitative interview study with PAH subjects to explore subject's perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). This will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 PAH subjects (each approximately 30 minutes in duration) in the United States (US).

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Other: Telephone concept elicitation interview

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02210
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

A sample of 8 to 10 US-English speaking subjects will be recruited. Recruitment will be facilitated by a third-party vendor in the US. A purposive approach to sampling will be employed to ensure subjects with a range of demographic and clinical characteristics are recruited.

Description

Inclusion Criteria:

• Male or female, at least 18 years of age.
• Subject is willing and able to provide written informed consent.
• Subject must have a diagnosis of symptomatic Pulmonary Arterial Hypertension Type I as per the World Health Organization (WHO) clinical classification system.
• Subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes.

Exclusion Criteria:

• Subject has a diagnosis of other cardiac or pulmonary disease.
• Subject has a Type II-V diagnosis of PAH, as per the WHO clinical classification system.
• Subject is currently receiving treatment for PAH via modes of administration other than intravenously or orally.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All subjects with PAH; A total of 8 to 10 US-English speaking PAH subjects will be recruited. They will take part in a 30-minute telephone concept elicitation interview. All interviews will be audio-recorded and transcribed verbatim.

Other: Telephone concept elicitation interview; All interview questions are designed to be very open-ended in order to ascertain subjects' preferences in an un-biased manner (as possible), with additional probes only being used when necessary to ensure all concepts of interest are covered. Subjects will be asked a series of broad, open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of taking oral treatment(s) for their PAH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who preferred subcutaneous injection versus current treatment options	All recruited subjects will take part in a 30-minute telephone interview. Subjects will be given brief descriptions of hypothetical injection and inhaled treatments and will be asked for their thoughts towards these treatments individually.	Up to 30 minutes

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Adelphi Values

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): April 10, 2018
• Study Completion (Actual): April 10, 2018

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Subcutaneous; Qualitative research; PAH; Telephone interviews; Low-interventional
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Pulmonary Arterial Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 207754

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No