Dementia Mental and Behavioural Disorders Unspecified dementia
Conditions
Interventions
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 o
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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 ascertained by a formal screening assessment completed after consent: 7. Mild dementia, defined as a score of 0.5 or 1 on the Clinical Dementia Rating Scale. The CDR will be completed during a face-to-face visit, as a post-consent screening assessment to determine eligibility for randomisation. Inclusion criteria for the supportive other: Note that participation of a supportive other is not mandatory and will be at the discretion of the participant. If the participant chooses to identify a supportive other they wish to participate with, the following inclusion criteria will apply: 1. Aged 18 or over; there is no upper age limit 2. Able to engage with and participate in the intervention 3. Able to provide informed consent 4. Able to read and communicate verbally in English
Exclusion criteria
Exclusion criteria: Exclusion criteria for the person with dementia: Living in institutional care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed