FACT Feasibility
Research type
Research Study
Full title
What is the feasibility and acceptability of conducting a randomised controlled trial evaluating a healthcare professional-supported, self-management intervention for people suffering from fatigue after critical illness?
IRAS ID
328471
Contact name
LC Stayt
Contact email
Sponsor organisation
Oxford Brookes University
ISRCTN Number
ISRCTN13813593
Duration of Study in the UK
1 years, 8 months, days
Research summary
AIM
To explore if it is possible to carry out a study testing a fatigue self-management programme for people who survive an intensive care unit (ICU) admission.WHAT DO WE KNOW?
Patients with life-threatening illness require care in an ICU. Approximately half of those who survive (approx. 82,000 per year) report fatigue lasting for a year or more. Fatigue is described as an overwhelming physical and mental exhaustion, not relieved by rest or sleep.
Fatigue has a devastating impact on every aspect of life, including being able to engage in rehabilitation, hobbies, work and affects people’s ability to look after themselves safely. Healthcare professionals (HCPs) do not know the best way to manage this problem. Working together with HCPs and former ICU patients, we developed a fatigue self-management programme to help people as they recover at home. The programme was well received during early tests with a small group of people suffering from fatigue after critical illness.
WHAT WILL WE DO?
In the future, we plan to test how effective this programme is, by comparing the experience of people affected by fatigue who receive it, with those who only receive standard aftercare. Before starting this large study, we need to ensure it is designed properly. To do this, we would like to conduct a feasibility (‘test’) study first to answer these questions:
1. Will people affected by fatigue after critical illness agree to take part?
2. If so, will they agree to be randomly (‘by chance’) selected to receive the programme or standard after care?
3. Is the programme acceptable to people affected by fatigue and the HCPs delivering it?
We will recruit 70 people affected by fatigue after critical illness from three large hospitals in England. In addition to standard aftercare, half will receive the self-management programme. This involves access to a website, containing educational materials about fatigue and how to manage it, and activities to help goal setting and action-planning for six months after hospital discharge. Three months after discharge from hospital, they will receive a 30-minute phone/video call from an HCP, who will help with goal setting and action-planning.
We will ask people affected by fatigue and HCPs their thoughts about the programme and the study using interviews and questionnaires.
PATIENT AND PUBLIC INVOLVEMENT
People affected by fatigue and their carers will work with us throughout this study to make sure it focuses on patients’ needs.
WHAT NEXT?
After the study has been completed, we will present the results at conferences and submit a report to scientific journals. We will summarise findings and share with patient groups. Results will help us decide whether it is appropriate to do a full trial to test how effective the intervention is.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0242
Date of REC Opinion
5 Dec 2024
REC opinion
Further Information Favourable Opinion