Promoting independence in dementia (PRIDE): a feasibility randomised controlled trial of the PRIDE intervention for people with mild dementia

INTERVENTION: Identification of potential participants Potential participants will be invited to take part by their usual care team, or may become aware of the study through Join Dementia Research or publicity through other relevant groups and organisations. All potential participants will be provided with a copy of the written participant information sheet and the researcher will arrange to visit the potential participant at home if they remain interested in taking part. Visit 1 At the first visit, the researcher will explain the study and obtain written consent from the participant. Basic demographic information will be collected and an initial assessment will be done to confirm if the participant is eligible to be randomised. If the participant is found not to be eligible to take part after this assessment, the researcher will explain this and will provide a brief report of the results, if this is requested. If the participant is eligible to take part, the researcher will continue with the visit and complete the baseline assessments and questionnaires. This visit should take no more than 90 minutes in total. The participant can also choose a supporter to take part in the study with them. The supporter will fill out questionnaires and will support the participant during the PRIDE programme. If a supporter would like to take part, they will be asked to be present and provide consent at the first visit. Randomisation When the first visit has been completed, and the participant is confirmed as suitable, they will be randomly allocated to receive the PRIDE programme and usual care or their usual care only. Participants will be individually allocated on a 1:1 ratio using minimisation with a probabilistic element. The minimisation variables will be study site, sex, age (< 80 or = 80) and medication for dementia (any versus none). Intervention phase CONDITION: Dementia ; Mental and Behavioural Disorders ; Unspecified dementia PRIMARY OUTCOME: The feasibility of conducting a full RCT related to participant recruitment and follow‐up, intervention delivery including the recruitment, training and retention of PRIDE trained facilitators, clinical outcomes, intervention and resource use costs and the acceptability of the intervention and study related procedures. SECONDARY OUTCOME: ; The following clinical outcomes will be measured to assess the relevance and acceptability of these outcomes for use in a future definitive RCT and to obtain information to inform selection of the primary outcome measure for a future trial. All outcomes are assessed at baseline, 3 and 6 month follow‐up.; 1. Activities of daily living measured using the Lawton Instrumental Activities of Daily Living (IADL) Scale; 2. Health‐related quality of life measured using the EuroQoL Quality of Life Questionnaire – 5 Domains, 5 Levels (EQ‐5D‐5L); 3. Quality of life measured using the DEMQOL; 4. Mood measured using the Geriatric Depression Scale (GDS); 5. Cognition measured using the Standardised Mini Mental State Exam (S‐MMSE); 6. Wellbeing measured using the Control, Autonomy, Self‐realisation and Pleasure (CASP); 7. Quality of relationships measured using the Social Relationships sub‐scale of the Impact on Participation and Autonomy Questionnaire for older people (IPAQ‐O); 8. Positive emotions measured using the Positive Psychology Outcome Measure (PPOM); 9. Social engagement measured using the number of social contacts and leisure activities per week; 10. Global rating of change assessed by the person with dementia and the supporter; 11. Resource use measured using a modified version of the Client Service Receipt Inventory (CSRI); INCLUSION CRITERIA: Inclusion criteria for the person with dementia: To be eligible for the trial participants must meet all of the following INCLUSION CRITERIA: 1. ­Resident within the catchment area of one of the participating NHS sites 2. ­Aged 18 or over; there is no upper age limit 3. ­Meet the Diagnostic and Statistical Manual of Mental Disorders‐Fourth Edition (DSM‐IV) criteria for dementia of any type, including Alzheimer’s, vascular, Lewy body type and mixed 4. ­Able to engage with and participate in the intervention in the judgement of the investigator or designee 5. ­Able to provide informed consent in the judgement of the investigator or designee 6. Able to read and communicate verbally in English In addition, to be eligible for randomisation, the following inclusion criteria must be met. This is a