VIStAA Study v.1.2
Research type
Research Study
Full title
Variations in Self-management of Acute illness in Primary Adrenal Insufficiency: A mixed methods study.
IRAS ID
217148
Contact name
Lisa Shepherd
Contact email
Sponsor organisation
RG_19-278
Clinicaltrials.gov Identifier
ERN_20-0040, University of Birmingham Ethics Reference Number
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
What are the differences in self-management of acute illness in Primary Adrenal Insufficiency?Primary Adrenal Insufficiency (PAI) is caused by the destruction of the adrenal glands and requires patients to take lifelong steroid replacement. To mimic the body’s normal response during acute illness, steroids need to be adapted appropriately. Failure to do so can lead to an adrenal crisis (AC) and caused 5,285 hospital admissions last year. Research has shown patients have the knowledge, but do not adapt their dose of steroid replacement during illness and require additional help from family and/or health care professionals.
This mixed methods study (Phase 2) aims to explore the behavioural differences in patients with Addison’s Disease who have Experienced Adrenal Crisis (EAC) and Prevented Adrenal Crisis (PAC) during acute illness.
Up to 300 participants will be purposively recruited from 6 regional centres and via the national support group. Participants will be prospectively followed and will receive a weekly text message enquiring if they have developed an acute illness during this time and subsequent management. Sequential patients who fulfil the criteria of an acute illness requiring additional steroids (and their family/friends) from both groups will then be invited to participate in the qualitative study.
In-depth semi structured interviews will be performed at a convenient place or via telephone/ skype lasting up to 60 minutes. The focus will be on knowledge application during times of need and identification of barriers and facilitators of behaviour change.
Data from the prospective study will be descriptive in nature. Interview data will be analysed using thematic analysis and a comparative analysis of the groups. The results will be utilised to inform the development of a behavioural intervention in the next stage of the project (Phase 3 of 4).
The study is funded by HEE/NIHR as part of a clinical doctoral fellowship.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0091
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion