Cognitive decline Mental and Behavioural Disorders Other and unspecified symptoms and signs involving cognitive functions and awareness
Conditions
Interventions
Intervention as of 21/09/2018
This feasibility trial will be used to examine the study and intervention procedures, to ensure that they are acceptable and feasible, in order to check that the future p
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participant inclusion criteria as of 11/10/2018: Cognitively impaired participants: 1. Aged between 60 and 85 years old 2. Have cognitive impairment: 1 SD below the norm for the Baddeley reasoning test. We will explore the impact in subgroups defined by combinations of impairment in Baddeley reasoning, IADL and memory. Key subgroups for those with cognitive impairment that are of particular interest are: 2.1. AACD: 1SD below norm for an average of 3 tests for Baddeley reasoning + 1sd below norm for Instrumental activities of Daily Living (IADL) 2.2. MCI: 1.5SD below norm for an average of 3 tests for Baddeley reasoning + 1.5 SD below norm for an average of 3 tests for impaired memory (self-ordered search test) 3. Be willing and able to access the internet Non-Cognitively impaired participants: To be eligible for inclusion individuals without signs of cognitive decline will: 1. Be aged between 60 and 85 years old 2. Have normal cognitive function (i.e. do not meet criteria for inclusion in the cognitively impaired trial) 3. Be willing and able to access the internet Previous participant inclusion criteria: To be eligible for inclusion, individuals with signs of cognitive decline will: 1. Be aged between 60 and 85 years old 2. Have either MCI (defined as 1.5 SD below the norm in a non-memory cognitive domain plus memory impairment or AACD (defined as 1 SD below the norm for the Baddeley reasoning test) 3. Be willing and able to access the internet To be eligible for inclusion individuals without signs of cognitive decline will: 1. Be aged between 60 and 85 years old 2. Have normal cognitive function (i.e. do not meet criteria for MCI or AACD) 3. Be willing and able to access the internet
Exclusion criteria
Exclusion criteria: 1. Have an existing diagnosis of dementia 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. Do not have access to the internet Individuals without signs of cognitive decline will be excluded if: 1. In full time employment (or are fully retired) 2. Have an existing diagnosis of dementia 3. 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)) 4. Do not have access to the internet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure as of 21/09/2018: Feasibility study 1. The ability to collect clinical outcome and notes review data, built around the stop/go criteria for the trial: the main trial will proceed if 80% of the clinical outcome and notes review data are available for analysis. If the figures are 70-80% the trialists will discuss with the steering committee their plans for appropriate mechanisms to increase response rate. If much less than 70% of the data is available, in negotiation with the funder they will consider not proceeding to the main trial unless there is a clear and plausible plan to increase response rates/reduce missing data. Main trial 1. Verbal reasoning (measured using the simple Baddeley reasoning test) Previous primary outcome measure: The ability to collect clinical outcome and notes review data, built around the stop/go criteria for the trial: the main trial will proceed if 80% of the clinical outcome and notes review data are available for analysis. If the figures are 70-80% the trialists will discuss with the steering committee their plans for appropriate mechanisms to increase response rate. If much less than 70% of the data is available, in negotiation with the funder they will consider not proceeding to the main trial unless there is a clear and plausible plan to increase response rates/reduce missing data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 21/09/2018: Feasibility study Feasibility in terms of: 1. Suitability of recruitment screening methods 2. Acceptability of all trial procedures, including recruitment strategies, randomisation, study materials, follow-up procedures and notes review 3. Recruitment and attrition rates 4. Acceptability of the digital intervention (assessed by uptake, usage and attrition and qualitative process evaluation) 5. Appropriateness of human support module (uptake, adherence, number of sessions and qualitative process evaluation) 6. Suitability of all outcome measures 7. Health economics analysis – the key resources to be collected, to inform choice of quality of life instruments to be used in the full trial Main trial (both cognitively impaired and non-impaired participants) at 1 year (and 5 years if funding is released for longer term follow-up): 1.Instrumental Activities of Daily living (the key secondary outcome) 2. Secondary cognitive outcomes: Spatial Working Memory through the self ordered search test; Digit vigilance (attention) through a version of the ‘digit span’ task; Verbal short-term memory (VSTM) measured through the paired associates learning (PAL) 3. Patient enablement (modified Patient Enablement scale) 4. Brief depression instrument: the short form of the Geriatric Depression Scale 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): we will document those who become cognitively impaired (defined as above, including MCI and AACD) 6. Mortality. 7. Health-related QoL. The feasibility study will determine which of three instruments will be used in the main trial: EQ5D (and proxy | — |
Countries
United Kingdom
Outcome results
None listed