ISRCTN14948133
Completed
未知
The Namaste Care intervention to improve the quality of dying for people with advanced dementia living in care homes: a feasibility study for a cluster randomised controlled trial
ancaster University0 sites328 target enrollmentOctober 4, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Advanced dementia
- Sponsor
- ancaster University
- Enrollment
- 328
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30478131 (added 28/10/2019) 2020 results in: https://www.ncbi.nlm.nih.gov/pubmed/31971506 (added 24/01/2020) 2021 serious adverse event reporting procedures in https://pubmed.ncbi.nlm.nih.gov/33472621/ (added 22/01/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for residents:
- •1\. Resident is a permanent resident within the nursing home (i.e. not present for receipt of respite or day care)
- •2\. Resident has a formal assessment of advanced dementia, (based on the Functional Assessment of Staging of Alzheimer’s Disease (FAST) score of 6\-7\) made by the nursing home manager or another experienced member of staff
- •3\. Resident lacks capacity (capacity assessed and documented with an appropriate tool)
- •4\. Resident has a key worker member of staff willing to provide proxy outcome data
- •Inclusion criteria for informal carers:
- •An informal carer meeting all of the following criteria will be eligible to join the feasibility trial if they:
- •1\. Are above the age of 18 who self\-define as a family member or friend who acts as an informal carer for a participant with advanced dementia
- •2\. Have the ability to communicate in English
- •Inclusion criteria for nursing home staff:
Exclusion Criteria
- •Resident exclusion criteria:
- •A resident meeting any of the following criteria will not be eligible to participate in the feasibility trial if the resident:
- •1\. Is permanently bedbound and unable to leave their room
- •2\. Is currently or recently involved in another research study or trial that conflicts with Namaste Care or with data collection during the course of the Namaste Care trial
- •3\. Has the capacity to consent
- •Informal carer exclusion criteria:
- •If the informal carer cannot communicate in English, they will not be eligible to join the trial
- •Nursing home staff exclusion criteria:
- •If the nursing home staff member has delivered Namaste Care to a resident in a nursing home setting which is not involved in this trial
Outcomes
Primary Outcomes
Not specified
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