Promoting activity, independence and stability in early dementia

Not Applicable

Completed

• Conditions: Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Neurological/ Other degenerative diseases of the nervous system; Not Applicable

• Registration Number: ISRCTN10550694
• Lead Sponsor: ottingham University Hospitals Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-31
• Study Completion: 2019-03-01
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. WP1:
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

Exclusion Criteria

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. WP3:
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified