ISRCTN10550694已完成未知
A programme of work to develop and evaluate an intervention to promote activity and independence for people with early dementia and mild cognitive impairment
ottingham University Hospitals Trust0 个研究点目标入组 60 人开始时间: 2016年8月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29468084 protocol 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29436253 development of the intervention 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31842828 results (added 18/12/2019) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35677674/ Social return on investment results (added 10/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.1. Health care staff with professional knowledge and expertise on falls, dementia, or related health conditions
- •1.2. The PPI focus group will be recruited from members of a established dementia-specialist PPI group
- •1.3. Patient and carer focus group, will be a group of people with mild dementia, meeting the inclusion criteria for the feasibility trial (recruited via Alzheimer Society)
- •2. WP2: Uptake and adherence focus group. A group of people with mild dementia, meeting the inclusion criteria for the feasibility trial, and their family carers (recruited via Alzheimer Society)
- •3. WP3 feasibility trial:
- •3.1 Age 65 or over (no maximum)
- •3.2. A diagnosis of dementia or MCI (of any subtype)
- •3.3. Able to walk without human help
- •3.4. Able to communicate in English, with a translator if necessary
- •3.5. Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
- •3.6. Capacity to give consent to participate, and agreeing to do so
- •3.7. Montreal Cognitive Assessment (MoCA) 15-25 or Mini-mental state examination (MMSE) 18-26 or Addenbrooke's Cognitive Examination (ACE-III) 50-83
- •4. Carer participants will be spouses, family members or others in a caring relationship who see the patient participant for at least an hour most weeks, are willing to take part and can communicate in English, with a translator if necessary
- •5. WP4: Patient participants will be drawn from those taking part in WP3 (supplemented by those in the main trial, WP5 if needed). Semi-structured interviews will be conducted with about 10 participants in each active-treatment arm in the feasibility study (moderate- and high- intensity supervision). Carers will be interviewed separately, if they are willing
排除标准
- •1. WP 1-2: There will be no specific exclusion criteria, but people recruited are likely to be those who would otherwise have been appropriate for the feasibility trial
- •2.1. Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson’s or other severe neurological disease)
- •2.2. Life expectancy of less than 1 year
- •2.3. Likely to be unable to undertake the intervention regularly (e.g. planned elective surgery, planning to move away or commitments elsewhere)
- •3. WP4 participants will be drawn from those taking part in WP3, exclusion criteria will be the same
研究者
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