Cognitive decline Mental and Behavioural Disorders
Conditions
Interventions
Fully powered, definitive trials will test the effectiveness and cost-effectiveness of both the standalone Active Brains digital intervention and the Active Brains digital intervention plus support fr
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals with signs of cognitive decline: 1. Aged between 60 and 85 years old. 2. Cognitive impairment defined as 1 SD below the norm on the Baddeley reasoning test. The researchers will also explore the impact in subgroups defined by combinations of impairment in Baddeley reasoning, IADL and memory. Key subgroups are MCI, which will be defined as 1.5 SD below the norm in a non-memory cognitive domain plus memory impairment, and AACD defined as 1 SD below the norm for the Baddeley reasoning test and IADL 3. Willing and able to access the internet Individuals without signs of cognitive decline: 1. Aged between 60 and 85 years old 2. Normal cognitive function (i.e. do not meet criteria for cognitive impairment as defined above) 3. Willing and able to access the internet
Exclusion criteria
Exclusion criteria: 1. Existing diagnosis of dementia at baseline 2. Report high levels of leisure time physical activity already (i.e. score 30 or more on the Godin Leisure Time Exercise Questionnaire (counting moderate or vigorous physical activity only)) 3. Terminally ill/ in receipt of palliative care 4. Seriously mentally ill (e.g. major uncontrolled depression, schizophrenia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive performance (verbal reasoning) measured using online version of the Baddeley Verbal Reasoning task at baseline and 1, 2, 3, 4 and 5 years 2. Dementia diagnosis, determined by data collected from patient notes review at 5 years Funding for five-year follow-up is contingent on evidence of effectiveness in changing behaviour and improving cognition at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ability to perform activities of daily living measured using Instrumental Activities of Daily Living scale (the key secondary outcome) at baseline and years 1, 2, 3, 4 and 5 2. Secondary cognitive outcomes measured at baseline and years 1, 2, 3, 4, and 5: 2.1. Spatial working memory measured using the self-ordered search test 2.2. Digit vigilance (attention) measured using a version of the ‘digit span’ task 2.3. Verbal short-term memory (VSTM) measured through the paired associates learning (PAL) 3. Patient enablement measured using modified Patient Enablement scale at years 1 and 5 4. Depression measured using the short form of the Brief Geriatric Depression Scale at baseline and year 1 5. Significant cognitive decline: 5.1. Diagnosis of dementia (among cognitively impaired participants defined at baseline): evidence from cognitive testing, notes review, and using Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) (short form) as necessary; at 5 years there will be input from a consensus panel 5.2. Cognitive impairment (among non-cognitively impaired individuals): the researchers will document those who become cognitively impaired (defined as above, including MCI and AACD) 6. Mortality collected from note reviews at year 1 and year 5 7. Health-related quality of life measured using EQ5D (and proxy versions of EQ5D if necessary) at baseline and years 1, 2, 3, 4 and 5, SWEMWBS -7 item at baseline and years 1 and 5, and SF-12 at baseline and years 1 and 5 8. Diet quality/dietary behaviour measured using brief validated food frequency questionnaire at baseline and years 1, 2, 3, 4, 5 9. Physical activity behaviour measured by IPAQ plus additional items about strength and balance at baseline and years 1, 2, 3, 4, 5 Other measures: Resource usage for the health economic analysis (medication, consultations, hospitalisation, A&E attendance, outpatient visits) extracted through notes review and health, medication and work status items at baseline years | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed