An intervention to improve recovery after delirium: feasibility study
Research type
Research Study
Full title
A multi-centre, single arm feasibility study of a complex intervention to improve Recovery after an Episode of Delirium in adults over 65 years: the RecoverED study
IRAS ID
302675
Contact name
Louise Allan
Contact email
Sponsor organisation
Royal Devon University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN15676570
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
We are testing the feasibility of a research study looking at a rehabilitation programme (intervention) to help people recover from an episode of delirium at home.
Delirium is a state of sudden mental confusion. Symptoms can include disorientation, delusions and paranoia, hallucinations and changes in mobility or balance. It happens as a result of another illness such as an infection or something that causes pain. Delirium is associated with poor outcomes such as increased length of hospital stay, hospital-acquired complications, distress, poor functional recovery and increased mortality.
We have designed a rehabilitation programme for people aged over 65 who are admitted to hospital with delirium. We aim to test the intervention in a single-group feasibility study of 60 patient and carer participant pairs to see if it is acceptable to participants and sufficient quality outcome data can be collected.
Patient and carer pairs will be recruited during the hospital stay. If a patient is found to lack mental capacity to give informed consent, we will approach a consultee (close family or friend). Once discharged home, participants will have an initial assessment visit followed by up to 10 rehabilitation sessions over a 12-week period. The rehabilitation programme will include activities to support cognitive, physical, emotional, functional and social elements of recovery. Examples include, exercises to improve mobility and independence, brain games, emotional support and sense-making sessions and education on nutrition and sleep management.
A clinical researcher will follow-up participants at 3- and 6-months post-discharge either at home or at the hospital to repeat most of the baseline assessments/questionnaires.
If we meet our feasibility study stop/go criteria, a separate randomised controlled trial will be set up in the future to compare the intervention with usual care. The primary outcome for the randomised controlled trial will be the patient participants' activities of daily living 6 months after discharge.
Lay summary of study results: Delirium is a serious condition that often affects older people, especially those with dementia. It causes confusion, difficulty focusing, and problems with memory and thinking. People with delirium in hospital often need more help on returning home due to problems with mobility and thinking. While most research has focused on preventing delirium, not enough attention has been given to helping people recover from it once back at home.
The RecoverED programme was designed to help older adults recover from delirium by supporting their physical, mental, and emotional well-being. The programme included exercises to help with physical recovery, activities to improve memory and thinking, and support to help people feel emotionally better.
Prior to the study we focused on creating the best possible recovery plan by talking to experts, patients, and carers. In the feasibility study, the programme was tested with older adults who had delirium in hospital, once they were back at home. We found 435 patients with delirium across six hospitals. 36 (8%) were suitable for the trial and 19 took part. Ten10 people (53%) completed final follow-up. The results showed that people found the programme helpful and felt better after taking part. However, if we had been able to recruit more people we may have found more changes that needed to be made. However, the study also faced difficulty finding enough participants, community rehabilitation staff to deliver it, and making sure the programme reached people from all backgrounds. We planned to go on to a full randomised controlled trial of the programme and a study of how to make it work in the NHS. However, we were unable to do this because of the difficulties in finding participants in the second part of the study.
Participants found the intervention helpful and felt they benefited from taking part. s The study showed that we need to improve how we recruit people, make it clearer who the programme is best suited for, and find better ways to support those with complex health needs. Future studies will need to address the challenges we found in recruitment. They should focus on involving people from different backgrounds and finding ways to make the programme available to more people who need it.
REC name
London - South East Research Ethics Committee
REC reference
22/LO/0613
Date of REC Opinion
24 Oct 2022
REC opinion
Further Information Favourable Opinion