Dementia Mental and Behavioural Disorders
Conditions
Interventions
We will conduct a two-arm, parallel-group, pragmatic, cluster-randomised controlled trial with nursing homes in each of the seven participating countries, with embedded process and economic evaluation
Sponsors
University College Cork
Masarykova univerzita (MUNI)
Jagiellonian University (Uniwersytet Jagiellonski)
University of Turin (Università degli Studi di Torino)
Radboud University Medical Center
Lancaster University
Queen's University Belfast
Universidade Católica Portuguesa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Nursing homes must have a typical number of beds with a minimum of 30, representing the predominant provider type in that country 2. Nursing homes must be located within a two-hour travel time from the partner university 3. Nursing homes must be able to recruit a sufficient number of eligible residents 4. Residents must have advanced dementia, defined as moderately severe to severe dementia according to FAST stage 6 or 7 5. Residents must have a family caregiver (care partner, care supporter, or advocate) involved in their care and support, including in care decisions 6. The participating adult family caregiver is not required to have legal representative status or decision-making authority for the resident 7. Nursing home staff and unpaid volunteers involved in the care of eligible residents are also included
Exclusion criteria
Exclusion criteria: 1. Nursing homes that already provide Namaste Care or the FCDS intervention at baseline 2. Nursing homes that participate in another clinical trial or research study involving residents with dementia 3. Residents for whom there is no consenting family caregiver available to take part in the trial 4. Residents who are unable or unwilling to be brought to a common social space 5. Residents who are actively dying, with death expected in the coming days or weeks as judged by nursing home staff 6. Residents who are acutely unwell or have been recently transferred from acute care and are not well enough to participate 7. Residents who have capacity to consent and refuse to take part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resident comfort assessed with the observational Discomfort Scale – Dementia of Alzheimer Type (DS-DAT) collected at baseline and at 4 time points with 3 monthly intervals over a 12 month period | — |
Secondary
| Measure | Time frame |
|---|---|
| Collected at baseline and at 4 time points with 3 monthly intervals over a 12 month period, where applicable: 1. Quality of life is measured using the Quality of Life in Late-Stage Dementia scale (QUALID) 2. Pain is measured using the Pain Assessment in Advanced Dementia scale (PAINAD) 3. Agitation is measured using the Cohen-Mansfield Agitation Inventory – Short Form (CMAI-SF) 4. Neuropsychiatric symptoms are measured using the Neuropsychiatric Inventory – Nursing Home version (NPI-NH) 5. Social engagement is measured using Resident Daily Activity Logs at baseline, and continuous for 12 months 6. Psychotropic medication use is measured using medication administration records 7. Adverse events (pressure ulcers, infections, and hospital transfers) are measured using clinical records 8. Care planning is measured using Chart Extraction Tool and Family Meeting Activity Logs at baseline and continuous for 12 months 9. Decisional conflict is measured using the Decisional Conflict Scale 10. Anticipatory and post-death grief are measured using the Prolonged Grief Disorder Scale (PG-13) 11. Personal quality of life (family) is measured using the EuroQol 5-Dimension Questionnaire (EQ-5D) 12. Satisfaction with care is measured using the Satisfaction With Care – End-of-Life in Dementia scale (EOLD-SWC) 13. Perceived comfort in dying is measured using the Comfort Assessment in Dying scale (EOLD-CAD) 14. Understanding of dementia as a terminal illness is measured using a single item in the Family Survey 15. Burnout is measured using the Maslach Burnout Inventory (MBI) 16. Job satisfaction is measured using a 7-point Likert scale 17. Personal quality of life (staff) is measured using the EuroQol 5-Dimension Questionnaire (EQ-5D) 18. Attitudes and perceptions of dementia care are measured using the Person-Centred Care Assessment Tool (P-CAT) 19. Competence and communication self-efficacy are measured using the Sense of Competence in Dementia Care Staff scale (SCIDS) | — |
Countries
Czech Republic, England, Ireland, Italy, Netherlands, Northern Ireland, Poland, Portugal, United Kingdom
Contacts
Public ContactNicola Cornally
Outcome results
None listed