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
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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
    Primary completion date:
    2017-02-06
    Observational study model:
    Cohort
    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.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Adults at least 18 years of age with a self-reported diagnosis of asthma and who are being treated for their asthma.
    • HCPs (primary care/family practitioners, allergists, pulmonologists, nurses) who provide care to adult patients with asthma.
    • Adults who are self-reported caregivers (e.g., spouses, parents) of patients diagnosed with asthma. Exclusion Criteria
    • Participated in qualitative research group discussions or one-on-one interviews in the past 6 months.
    • Final eligibility criteria for the three study populations (asthmatic patients, HCPs, and caregivers) will be determined based on results of the online focus groups and pre-test activities.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

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

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website