▪ What are the methods and techniques used?
We will recruit people with dementia to the trial if they have had a fall in the last 6 months. We will include people who have a diagnosis of dementia recorded by their GP. They will need to be living in their own home after the fall. They will need to have a carer (friend or family member) who is able to help them keep a diary of any further falls and also answer questionnaires about the person with dementia. They will need to either be able to consent to the study themselves or have someone who is able to provide an opinion as to whether they would be happy to participate in the study.
Each area where the study is being carried out will be randomly allocated to receive either the intervention or usual care. This is called cluster randomisation. This type of allocation is used when there is a possibility that the professionals carrying out an intervention would use the training we give them to help all the patients in a given service.
The intervention will include an assessment of the reasons for any falls and identification of any actions which need to be carried out to reduce the risk of falling or improve independence e.g. by providing equipment. This will be followed by a 12 week programme of activities in the home facilitated by a team including a physiotherapist, an occupational therapist, support workers and a Geriatrician. Participants will receive up to 19 visits by the therapists over the first 12 weeks. All participants will receive 3 additional (booster) sessions which will take place up to 6 months. We will assess the participant’s likes and dislikes for different activities and what goals they would like to achieve in becoming more independent. The activities will be targeted at achieving personal goals chosen by the participants such as being able to out to get the bus or being able to make a cup of tea. Activities will be carried out mainly in the participant’s own home, but could take place outdoors if the person has a goal to get outdoors. Carers will be given support and training in caring for someone who has falls and they will be referred to organisations which support people who care for someone with dementia. We will provide training for staff in how to deliver the intervention.
We will follow participants up at 6 months to measure their independence in usual daily activities, ability to move about, fear of falling, whether they achieved their goals, quality of life and impact on caregivers. We will ask participants to keep a diary of how many falls they have for 6 months together with the health services they used and care they required. We will interview participants, their carers and professionals to find out how well the intervention worked and anything that could be done to improve it before going on to a main trial. We will also observe some of the sessions delivered by the professionals to check that the intervention is being delivered as we expect.
▪ How many people are we planning to recruit, how do we aim to do this and how do we justify this?
We aim to include 60 people in the study which will allow us to estimate with confidence how many people are likely to take part in a future full randomised controlled trial. This is one of the main factors which will determine whether it is likely that a full trial would be successful.
We will recruit people from emergency departments, rehabilitation teams, paramedics, primary care and memory clinics. We will not use Join Dementia Research or other research registers because in our previous project we contacted a large number of JDR participants and did not find people who had had recent falls, so this was not useful in finding participants.
People with dementia who seek help for a fall at one of the services where we are recruiting will be offered a brief information sheet about the trial. If they are interested in the trial they will be given more detailed information by a research nurse. The research nurse will then visit the patient and their carer at home to answer any questions, seek consent for them to take part in the study and obtain initial information about the participant.