Last updated: 07/28/2020 06:20:05
Salford Lung Studies: Follow-up Interviews on Patient-Centred Outcomes
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Salford Lung Studies: Follow-up Interviews on Patient-Centred Outcomes
Trial description: This exploratory, qualitative study involves follow-up interviews with a sample of 350 to 400 asthma subjects who completed the Salford Lung Study (SLS) in Asthma. SLS-Asthma is an ongoing, 12-month, real-world study of asthma treatments (fluticasone furoate/vilanterol inhalation powder [Ellipta] vs. standard of care [SOC]). The follow-up interviews will be conducted, either by telephone or face to face, by trained interviewers from the SLS community team using a structured interview schedule. The current study is planned to obtain the information related to subject experience in the SLS-Asthma as well as the impact and management of disease from the subject’s perspective.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Socio-demographic, general health, lifestyle, behavioural and psychological variables of the subjects taking part in SLS-Asthma study
Timeframe: Up to 2 weeks
Disease impact for the SLS-Asthma in terms of symptoms, sleep, physical, social, and psychological burden, including subject’s priorities and perceptions of change
Timeframe: Up to 2 weeks
Self-management practices and awareness of asthma amongst the subjects taking part in SLS-Asthma study
Timeframe: Up to 2 weeks
Subjects’ preferences and satisfaction for asthma treatments used in the SLS-Asthma
Timeframe: Up to 2 weeks
Level of medication adherence attitudes and beliefs of the subjects taking part in SLS-Asthma study
Timeframe: Up to 2 weeks
Secondary outcomes:
Difference in Level of asthma control in the subjects taking part in SLS-Asthma study
Timeframe: Up to 2 weeks
Difference in randomized treatment group in the SLS-Asthma study
Timeframe: Up to 2 weeks
Interventions:
Enrollment:
1
Primary completion date:
2016-21-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Lynda Doward, Henrik Svedsater, Diane Whalley, Rebecca Crawford, David Leather, James Lay-Flurrie, Nick Bosanquet. A descriptive follow-up interview study assessing patient-centred outcomes: Salford Lung Study in Asthma (SLS Asthma). npj Prim Care Respir J. 2019;29(1):31
DOI: 10.1038/s41533-019-0142-x
PMID: 31417102
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
RTI Health Solutions, University of Manchester and North West e-Health (NWeH), Salford Royal NHS Foundation Trust (SRFT)
Study date(s)
December 2015 to August 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Inclusion Criteria:
- SLS-Asthma completion: Attending end of study (EOS) visit (Visit 6).
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- SLS-Asthma completion: Attending end of study (EOS) visit (Visit 6).
- Informed consent: Subjects must be able to provide informed consent, and have their consent signed and dated.
- Ability to participate in a qualitative interview: Subjects must have sufficient command of the English language to be able to participate in a qualitative interview with an English-speaking interviewer. Given the nature of the study, language gains special importance as the means by which the interviewee constructs their reality and the interviewer interprets their meaning. The introduction of interpreters for non-English speakers will result in a loss of meaning and potential misinterpretation that can introduce a bias into the analysis.
Trial location(s)
Location
GSK Investigational Site
Altrincham, Cheshire, United Kingdom, WA14 2NW
Status
Study Complete
Location
GSK Investigational Site
Altrincham, Cheshire, United Kingdom, WA14 5PF
Status
Study Complete
Location
GSK Investigational Site
Eccles, Manchester, United Kingdom, M30 8QD
Status
Study Complete
Location
GSK Investigational Site
Irlam, Manchester, United Kingdom, M44 5LH
Status
Study Complete
Location
GSK Investigational Site
Manchester, Greater Manchester, United Kingdom, M20 2RN
Status
Study Complete
Showing 1 - 6 of 20 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
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
Study complete
Actual primary completion date
2016-21-11
Actual study completion date
2017-18-08
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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