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CompletedNCT03304548Updated Apr 2, 2019

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

An observational study in Hypertension, Pulmonary, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Hypertension, Pulmonary

Keywords

  • Telephone interviews
  • Subcutaneous
  • Low-interventional
  • Qualitative research
  • PAH
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherTelephone 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 minutes

06

Study locations

1 site
  • GSK Investigational Site
    Boston, Massachusetts 02210, United States
07

Registry details

Key details

Study ID
NCT03304548
Lead sponsor
GlaxoSmithKline
Collaborators
Adelphi Values
Responsible party
Sponsor
First posted
Oct 9, 2017
Start date
Nov 22, 2017
Primary completion
Apr 10, 2018
Completion
Apr 10, 2018
Last update
Apr 2, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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