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

NCT03304548 | Completed

• 1 other identifier: 207754
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hypertension, Pulmonary

Keywords

Telephone interviews; Subcutaneous; Low-interventional; Qualitative research; PAH

Outcome Measures

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.

  Up to 30 minutes

Study Arms (1)

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

Telephone concept elicitation interview OTHER

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.

All subjects with PAH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Adelphi Values: collaborator

Study Sites (1)

GSK Investigational Site

Boston, Massachusetts, 02210, United States

Location

Related Links

• Results for study 207754 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 9, 2017
• Study Start: November 22, 2017
• Primary Completion: April 10, 2018
• Study Completion: April 10, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

US (1)