Dementia Mental and Behavioural Disorders Dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. People with dementia (of any gender): 1.1 > 60 years of age 1.2 Have either 1.2.1 A formal diagnosis of dementia (mild to moderate dementia) 1.2.2 Their GP believes they have memory problems and the person has a provisional diagnosis of dementia based on the DSM-IV criteria 1.2.3 Are prescribed dementia medications 1.3 Living in the community 1.4 Willing and capable of undertaking the exercise component of the intervention 1.5 Able to speak in and read English 1.6 Able to give informed consent 1.7 Their primary caregiver is also willing to take part in the study 2. Carers of People with dementia (of any gender): 2.1 Primary caregiver of a person with dementia who has also agreed to participate in the study 2.2 Does not have a diagnosis of dementia 2.3 Living in the community 2.4 Willing and able to participate in the 6 weeks Caregiver education programme 2.5 Able to speak in and read English 2.6 Able to give informed consent
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility study outcomes (this line added 11/05/2020): 1. Number and proportion of participants (people with dementia, caregivers) who are screened, judged eligible and agreed to take part in the study 2. Follow-up rates outcome completion and adherence/compliance 3. Reasons for non-recruitment, non-adherence or attrition 4. Feasibility and acceptability of the intervention content, delivery, and fidelity assessments 5. Acceptability of the recruitment process, assessments, data collection tools, intervention content & delivery 6. Willingness of key gatekeepers to recruit participants (people with dementia and caregivers) 7. Calculate baseline score and variability of primary outcome measures among participants (updated 25/10/2023; previously secondary outcome measures) 8. Evaluation of the cost analysis process 9. Identification of barriers and enablers to stigma change in dementia 10. Identification of optimal strategy for recruitment of participants for future definitive trial | — |
Secondary
| Measure | Time frame |
|---|---|
| The feasibility and acceptability of the following secondary outcome measurement tools [for use in a future definitive trial] (added 11/05/2020) will also be explored: 1. Completed by carers pre and post the 15-week intervention: 1.1 Zarit Carer burden interview (ZBI) to assess the level of burden 1.2 Short sense of Competency Scale (SSCS) to measure the sense of competence 1.3 Dementia Knowledge 20 (DK20) to measure knowledge of dementia 1.4 Resource Utilisation in Dementia – (RUD-lite) to measure healthcare resource utilisation 1.5 Adult carer quality of life (AC-QoL) to measure the overall quality of life of adult carers 2. Completed by people with dementia pre and post the 15-week intervention: 2.1 Mini Mental State Examination (MMSE) to screen for dementia and measure changes in cognitive function 2.2 Quality of Life- Alzheimer’s Disease (QoL-AD) to measure Quality of Life 2.3 Stigma Impact Scale (SIS) to measure self-perceived levels of stigma 2.4 Positive Psychology Outcome Measure (PPOM) to measure resilience 2.5 EQ-5D-5L to measure health status for economic appraisal 2.6 Fitbit to measure sleep quality and physical activity 2.7 The Geriatric Depression Scale – Short Form (GDS-S) to measure depression in older adults. 3. Completed by members of the public pre and post 15-week intervention: 3.1 Dementia Attitudes Scale (DAS) to measures attitudes towards dementia 3.2 Dementia Knowledge 20 (DK-20) to measure knowledge of dementia | — |
Countries
Ireland