The Active Brains study - feasibility trial

INTERVENTION: 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 planned RCT can be carried out successfully. The future planned fully powered definitive trial will test the effectiveness and cost‐effectiveness of both Active Brains and Active Brains plus support from a central facilitator, to see if either of these interventions can maintain cognitive function and prevent cognitive decline in 1) individuals with cognitive impairment but particularly people who currently show signs of Mild Cognitive Impairment (MCI) or Age Associated Cognitive Decline (AACD), and 2) people who do not show any signs of cognitive decline. The findings of the feasibility study may be used to make modifications to the study or intervention procedures to ensure the success of the definitive trial. In both the feasibility and fully powered trials, patients will be randomly allocated to one of three groups: 1. Usual care 2. Access to the Active Brains website 3. Access to the Active Brains website with flexible human support from a central support facilitator The trialists will recruit a cohort of patients with cognitive decline and a cohort without cognitive decline. 1. In patients with cognitive decline they will recruit a minimum of 60 patients to each of the three groups, approximately half of these patients will have MCI and half will have AACD. 2. In patients without cognitive decline they will recruit a minimum of 60 patients to each of the three groups. This means the total sample size across both cohorts will be a minimum of 360 participants. We will explore a range of recruitment strategies to see which are most feasible and effective to carry forward into the main trial. Participants will be recruited via Primary Care, and possibly through charity databases (DPUK, JDR) or media campaigns. Primary Care recruitment will involve practice st CONDITION: Specialty: Primary Care, Primary sub‐specialty: Ageing; UKCRC code/ Disease: Mental health/ Organic, including symptomatic, mental disorders ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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. 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 cogn SECONDARY OUTCOME: 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 versions of EQ5D if necessary); ICE CAP; and the SF 12.; 8. Brief validated food frequency, physical activity questionnaires, including the assessment of sedentary time.; ; Other measures:; 1. Resource usage for the Health Economic analysis (medication, consultations, hospitalisation, A&E attendance, outpatient visits) will be extracted through notes review.; ; Implementation assessment; 1. Web usage. With informed consent, we will analyse all website usage, which is unobtrusively automatically collected by the online systems, including time spent on each page and entries (e.g. goal setting and goal‐related progress in all behaviours).; 2. Self‐reported behaviours and their determinants.; 3. Qualitative process studies of 12‐18 patients from each study arm.; ; Previous secondary outcome measures:; 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