Maintaining Independence in People with Dementia who had a fall
Research type
Research Study
Full title
An intervention to maintain independence in People living With Dementia, living in their own homes, who have already fallen: a multi-centre, two-arm pilot cluster randomised controlled trial
IRAS ID
323555
Contact name
Louise Allan
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Foundation Trust
ISRCTN Number
ISRCTN16413728
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Summary of Research:
To deliver a pilot cluster RCT of an intervention to maintain independence in PWD, living in their own homes, who have already fallen. This will enable us to
determine whether it is feasible to proceed to a full cluster randomised controlled trial of the intervention.People with dementia fall over up to ten times more often than people who do not have
dementia. When they fall over, they are more likely to hurt themselves. They are less likely to recover than people without dementia. After a fall people with dementia may need a lot more help and they, and their carer, may have a poorer quality of life.We have designed a rehabilitation programme for people with dementia aged over 50 who have had a fall in the past 6 months. We aim to test the intervention in a two-group pilot study of 60 patient and carer participant pairs.
Patient and carer pairs will be recruited through community settings (primary care, paramedics, admiral nurses), secondary care settings (emergency departments, supported discharge teams, rehabilitation outreach teams, memory clinics) and research registers. If a patient is found to lack mental capacity to give
informed consent, we will approach a consultee (close family or friend). At their homes, participants will have an initial assessment visit followed by up to 19 rehabilitation sessions over a 12 week period with booster sessions at weeks 16, 20 and 24. The rehabilitation programme will be personalised to each participant, taking into account their physical abilities, their preference for activities and goals agreed by the therapist, the patient participant and their unpaid carer.A clinical researcher will follow-up participants at 3-months over the phone and at 6-months at the participants home.
Summary of Findings:
People with dementia fall over more often than people who do not have dementia. They are less likely to recover than people without dementia. After a fall people with dementia may need more help and they, and their carer, may have a poorer quality of life. In a previous study, we developed and tested a package of care (intervention) to help people recover from a fall. In this study we carried out a pilot randomised controlled trial in a small group of people to help us decide whether it would be possible to carry out a full randomised controlled trial of the intervention.We will recruited 31 people with dementia to the trial if they have had a fall in the last 6 months. 18 participants were randomised to receive either the intervention and 13 were randomised to receive usual care.
The intervention included an assessment to identify any actions which need to be carried out to reduce the risk of falling or improve independence. This was followed by a 12 week programme of activities facilitated by a team of therapists. Additional (booster) sessions took place up to 6 months. The activities were targeted at achieving personal goals chosen by the participants.
We followed participants up at 6 months to measure their independence in daily activities, mobility, fear of falling, falls, whether they achieved their goals, quality of life, caregiver burden and the health services and care they required.
Recruitment (84%) and retention (81%) targets were met. Most intervention participants (89%) attended ≥60% of planned sessions. Outcome measures and economic data collection showed high completion and acceptability. The intervention was well received by participants and professionals. Some adjustments were suggested and we have changed our procedures to make the intervention ready for a full trial.
We are now applying for funding to carry out a full randomised controlled trial to assess whether the intervention works and is good value for money.
REC name
Wales REC 6
REC reference
23/WA/0126
Date of REC Opinion
28 Apr 2023
REC opinion
Favourable Opinion