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Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment 2

Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment 2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15320670
Enrollment
736
Registered
2018-09-04
Start date
2018-09-10
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, mild cognitive impairment Mental and Behavioural Disorders

Interventions

The study will use a randomized controlled trial design to test the clinical and cost-effectiveness of a package of interventions designed to promote activity and independence and reduce falls, amongs

Sponsors

Nottingham University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 65 years or over (no maximum) 2. Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia) 3. Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant 4. Able to walk without human help 5. Able to communicate in English 6. Able to see, hear and have dexterity sufficiently to perform neuropsychological tests 7. Have capacity to give consent to participate, and consenting to do so

Exclusion criteria

Exclusion criteria: 1. Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson’s or other severe neurological disease) 2. Life expectancy of less than one year 3. Likely to be unable to undertake the intervention regularly (e.g. planned elective surgery, planning to move away or commitments elsewhere).

Design outcomes

Primary

MeasureTime frame
Disability in activities of daily living, assessed using Disability Assessment in Dementia (DAD) at 12 months after randomisation

Secondary

MeasureTime frame
1. Self-reported Activities of Daily Living (ADL) measured using the Nottingham Extended ADL Scale at baseline and 12 month follow up 2. Falls rate measured by monthly diary up to 15 months 3. Quality of life measured by questionnaires DEMQOL-self, DEMQOL proxy and EQ5D3L (self) at baseline and 12 months; EQ5D5L (proxy) at baseline, 6 and 12 months; Demqol-u weights at 6 months 4. Cognition measured by three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment, verbal fluency (from MoCA) at baseline and follow up 5. Time to first fall, rate of fractures and injurious falls measured by monthly diary and adverse events reporting (fractures). Data on falls, injurious falls and fractures are also collected at baseline 6. Rate of hospital and care home admissions, and days spent in hospital are measured by questionnaire at baseline, 6 and 12 months and by monthly diary and hospital administrative records at 12 months. Care home admissions also can be reported at any time in the study by staff 7. Rate of hospital and care home admissions, and days spent in hospital measured by monthly diary and hospital administrative records 8. Carer strain measured by Caregiver Strain Index at baseline and 12 month follow up 9. Carer health-related quality of life measured by questionnaire EQ5D-5L at baseline and 12 month follow up 10. Personality measured by Big Five Personality Inventory– short questionnaire at baseline and 12 month follow up

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026