Last updated: 12/10/2019 15:40:11

Observational Vignette Study to Examine Patient, Healthcare Provider, and Informal Caregiver Perceived Burden of Asthma-Related Exacerbations

GSK study ID
206435
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Observational Vignette Study to Examine Patient, Healthcare Provider, and Informal Caregiver Perceived Burden of Asthma-Related Exacerbations
Trial description: Asthma is a chronic inflammatory disorder of the airways and an important aim of asthma management is to prevent exacerbations. It is important to understand the impact of asthma exacerbations on patients’ health-related quality of life (HRQoL) from the perspective of patients as well as healthcare professionals (HCPs) and informal caregivers of asthma patients. This is a low interventional, prospective, cross-sectional, vignette study to examine the perceived burden of asthma-related exacerbations on asthma patients as assessed by: a) asthma patients; b) health care providers who manage asthma (primary care practitioners, allergists, pulmonologists, nurses); and c) informal caregivers (e.g., spouses and parents) of asthma patients. Study participants will be recruited from opt-in members of an online panel and the three cohorts of panelists (asthma patients, HCPs, informal caregivers) will be independent of each other. This study will be conducted using a multi-step approach with the first step being to develop a vignette-based survey instrument. The vignettes will be designed to simulate hypothetical profiles of asthma patients who experience mild, moderate or severe exacerbations. Online bulletin board focus groups will be conducted to inform development of the vignettes and selection of other measures for inclusion in the survey instrument. Initial web-based survey instruments will be developed for each of the three target participant groups (asthma patients, HCPs, caregivers), then pre-tested and pilot- tested before the full survey is launched. Approximately 900 subjects in total (~300 subjects per asthma patient, HCP, and caregiver cohorts) will be enrolled for the full survey.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To examine the burden of asthma-related exacerbations on asthma patients as assessed by asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To examine the burden of asthma-related exacerbations on asthma patients as assessed by HCPs that treat asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To examine the burden of asthma-related exacerbations on asthma patients as assessed by informal caregivers of asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

Secondary outcomes:

To examine the relationship between asthma patient-perceived and HCP-perceived burden of asthma-related exacerbations on asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To examine the relationship between asthma patient-perceived and informal caregiver-perceived burden of asthma-related exacerbations on asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To estimate the disutility values associated with the perceived burden of asthma-related exacerbations on asthma patients as assessed by asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To estimate the disutility values associated with the perceived burden of asthma-related exacerbations on asthma patients as assessed by HCPs that treat asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

To estimate the disutility values associated with the perceived burden of asthma-related exacerbations on asthma patients as assessed by informal caregivers of asthma patients

Timeframe: Outcome measured at the time of the full survey (estimated 2 week field period)

Interventions:
Other: Pilot test and implementation of final survey instrument
Other: Online bulletin board focus group
Other: Pre-test of initial survey instrument
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
2017-02-06
Time perspective:
Cross-Sectional
Clinical publications:
Johnson PT, Bell CF, White J, Essoi B, Nelsen L, Averell CM. Observational vignette study to examine patient and healthcare provider perceived impact of asthma-related exacerbations in the US. Multidiscip Respir Med. 2019;14(32)
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2016 to June 2017
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
  • Inclusion Criteria
  • Adults at least 18 years of age with a self-reported diagnosis of asthma and who are being treated for their asthma.

Trial location(s)

No location data available.

Study documents

Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2017-02-06
Actual study completion date
2017-02-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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