Digital Interventions in Neuro-Rehabilitation: A Small Scale Randomised Clinical Trial to Test a Web-based Therapy Application for People With Naming Difficulties With Mild- Moderate Dementia (Gotcha!).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in performance on the Gotcha Outcome Measure (GOM) over time
研究概览
简要总结
Aims and background Everyone forgets the names of people they should know at times. Having dementia makes this problem worse. People with dementia have told expressed they forget the names of people they care about and this can be upsetting and embarrassing.
However, evidence shows that if people get enough practice, they can re-learn these names. The investigators, along with people with dementia and their carers, have created a fun therapy for people to get lots of practice so they can remember the names of people that are important to them.
The main aim of the study is:
To prove that Gotcha! therapy can help people with dementia to improve their ability to remember names.
Another aim is:
To find out if using the therapy is related to any changes in the brains of people with dementia.
Design and methods Participants are provided with a computer tablet to practise at home. Participants are required to think of 6-10 familiar people (family and friends) whose names they forget and want to remember better.
Participants also need to practise every day for about 30 minutes over a 6 week period so they get a large amount of therapy.
Participants will have 7 testing appointments over 12 months. At three of these appointments participants will need to have a brain scan. These scans are carried out by trained University College London professionals and will take no longer than 30 minutes each.
For the appointments where participants do not need to have a brain scan home testing can be arranged.
The investigators organise and pay for all journeys to and from University College London.
Participants
Participants can get involved in our research if they:
- Have ever experiences seeing a familiar person but can't remember their name
- Have a diagnosis of dementia (Alzheimer's disease or mixed dementia).
- Want to be part of an important and exciting research journey. Unfortunately a diagnosis of other any other types of dementia not mentioned above is not suitable for this study
Patient and Public involvement The investigators have engaged with people from the Alzheimer's Society and local dementia carers groups, run many focus groups and interviewed people with dementia and their carers to co-design the therapy.
At the end of our research participants are invited to University College London to learn about the results of the study.
详细描述
Background
The number of people with dementia in the UK is forecast to increase by 40% over the next 12 years and 156% over the next 38 years (Prince et al., 2014). People with all stages of Alzheimer's disease (AD) report forgetting even very familiar people's names, which patients find annoying and embarrassing (Werner, 2004). This therapy speaks to the James Lind Alliance's dementia top priority, "What are the most effective components of care that keep a person with dementia as independent as they can be at all stages of the disease in all care settings?" Several case studies and one group study have shown that patients with AD can significantly improve proper name recall with training; the effects last months after training is completed (Clare et al., 2002). Given the prevalence of mobile phone technology with inbuilt cameras and the rapid rise in usage in the 64-74 year old bracket, the investigators will develop a name-training intervention that allows people with proper name recall impairments to take pictures of and add the name of people that they wish to name. The app will include voice recognition software so that our bespoke adaptive algorithm (developed with Prof Mark Huckvale at UCL) will be able to adaptively cue users depending on their speech output.
Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming people they know well.
This Digital Neuro Intervention (DNI) will provide the opportunity for the necessary increased rehabilitation to help people recover lost naming function. This will alleviate NHS Speech and Language Therapist (SALT) time and put users in control of when and where they carry out practice-based language therapy.
Identification and description of the Investigational Device
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person with mild/moderate dementia
- •Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language
- •Able to tolerate MRI brain scan
- •Able to give informed consent
- •Able to use the DNI (app)
排除标准
- •No diagnosis of developmental language disorders
- •No diagnosis of severe dementia or primary progressive aphasia
- •No major co-existing neurological or psychiatric diagnosis
- •No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).
结局指标
主要结局
Change in performance on the Gotcha Outcome Measure (GOM) over time
时间窗: Baseline (week 1), pre-intervention (week 12) ,post-intervention (week 18)
The Gotcha Outcome measure is a personalised test specific to each participant that enters the study. Each participant is required to select photographs of people whom they struggle to name. These photographs are used to create a personalised confrontation naming test i.e participants are shown a picture of a person they want to name better, they then get 8seconds to give a response. If a participant correctly names the person they were shown they are given a binary score of 1 (0 if they name incorrectly or cannot name). These scores can then be totalled and a percentage accuracy can be devised. The change in accuracy from baselines to pre therapy (6weeks) and pre therapy to post therapy time-points (6 weeks) is the primary outcome measure in the study.
次要结局
- Participant reported outcome measures(pre intervention (week 12), post intervention (week 18))