Self-management and HeAlth Promotion in Early-stage Dementia With E-learning for Carers - SHAPE: A Multicentre, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 5
- 主要终点
- Change in general self-efficacy
研究概览
简要总结
This study aims to assess if an educational programme combining approaches of self-management, health promotion, and e-learning will improve self-efficacy and other key health and mental health outcomes for people with mild to moderate dementia.
详细描述
It is currently estimated that 47 million people are living with dementia today and this number is expected to double in the next 20 years. Unfortunately, there has been limited advancement in medical treatments for dementia and new cost-effective approaches are needed. The utility of self-management has been proven to be of benefit in certain chronic diseases, however, very little work has been undertaken regarding self-management in people with dementia.The SHAPE self-management group therapy aims to significantly improve self-efficacy in people with mild to moderate dementia and to improve key health and mental health outcomes, carer stress and knowledge of dementia.SHAPE comprises a 10 week online course delivered as group sessions for the participants with dementia. The sessions are designed to develop self-management skills and to provide information on the disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. E-learning resources will be provided for carers (study supporters) which covers the similar and complimentary material discussed in the group sessions for the participant with dementia.
This trial uses 2:1 randomisation and will assess the clinical and cost effectiveness of SHAPE. Participants will be randomised to participate in the SHAPE intervention or continue with usual care. To assess the effectiveness of SHAPE at improving self-efficacy and secondary outcomes a battery of questionnaires will be administered to the participants and study supporters at baseline, after SHAPE participants have completed the intervention, and 9 months after randomisation. The answers to these questionnaires will be assessed and the results compared between the two groups of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia according to the ICD-10 classification or the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or V
- •65 years of age or older
- •Mild to moderate dementia, as associated with tMMSE ≥15
- •Ability to read and write
- •Hearing and vision that are sufficiently good to work in a group setting
- •Capacity to give consent for participation in the study
- •Proficient in the language in which the intervention is provided
- •Care partner willing to participate
排除标准
- •A diagnosis of alcohol or drug abuse
- •Lewy body dementias, Fronto-temporal lobar degeneration or Semantic dementia
- •A limited life expectancy due to any terminal disease or other serious illness, other than dementia
- •Chemotherapy or radiation treatment ongoing at enrolment
- •Currently participating in health promotion or self-management group
研究组 & 干预措施
Treatment as usual
Participants in the TAU arm will receive normal services such as clinical reviews, psychiatric appointments and other services when needed. With TAU as the comparator condition ensures that participants receive any needed services and enable comparison between current best practice and the new intervention of SHAPE
SHAPE Intervention
This group will receive the online group based self-management course develop self-management skills in areas including decision making, symptom management and social interaction and to provide information on the disease process and the development of healthy behaviours in a supportive learning environment to prevent problems that are common in the later stages of the disease. Key themes of the intervention will include positive actions to improve and maintain health, how to talk about the impact of the disease on the life of the person with dementia, fear of losing independence and how to tackle and solve other sensitive issues. Running in parallel there will be an e-learning resource available to the carers which covers the similar material covered in the group sessions for the person with dementia, as well as some additional resources and signposting to help them in their role supporting the person with dementia.
干预措施: SHAPE (Behavioral)
结局指标
主要结局
Change in general self-efficacy
时间窗: Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up)
Measured by the General Self-Efficacy Scale, a 10-item psychometric scale where each item is scored on a 4 point scale ranging from 'Not at all true' to 'Hardly true', to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
次要结局
- Change in Health-related Quality of life (HRQL)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in wellbeing(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in cognition(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in mood (anxiety, depression)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in Quality of life(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in health behaviours(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Cognition and function(Baseline)
- Change in neuropsychiatric symptoms(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in knowledge about dementia(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in quality of adjusted life-years (QALY)(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in carer stress(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in perceived access to service use(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in cost of care(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))
- Change in function(Baseline to 3 months (primary time-point), and 9 months after baseline (follow-up))