Topic: Dementias and Neurodegenerative Diseases Research Network
Conditions
Interventions
Dementia Care Mapping, This is a cluster randomised trial and randomisation will be at the care-home level. Care homes will be randomised to Usual Care, or Usual Care plus Dementia Care Mapping.
Follow Up Length: 16 month(s)
Sponsors
Leeds Beckett University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/06/2016: Care homes: 1. Have a minimum of 24 permanent residents 2. Have 60%+ permanent residents with dementia based on a formal diagnosis or Functional Assessment Staging of Alzheimer?s Disease (FAST) (score of 4+) rated with the home manager or another experienced member of staff 3. Have a manager or nominated person agreeing to sign up to the trial protocol as research lead for the duration of the project, based on appropriate discussions and permissions 4. Agree to release staff for DCM training and subsequent mapping processes 5. Be within catchment area Residents will be recruited at baseline (pre-randomisation) and 16 months post randomisation, as part of the open cohort design. Residents meeting all of the following criteria at screening will be eligible for this trial: 1. Be a permanent resident within the care home defined as a person residing in the care home and not present for receipt of for respite or 5-day- care 2. Have a formal diagnosis of dementia or score 4+ on the Functional Assessment Staging of Alzheimer’s Disease (FAST) [87] rated with the home manager or another experienced member of staff 3. Be appropriately consented (in accordance with Mental Capacity Act and clinical trials guidance on informed consent) 4. Have an allocated member of staff willing to provide proxy data. 5. Have sufficient proficiency in English to contribute to the data collection required for the research. Note that residents will NOT be excluded if they lack capacity to consent. Guidance on consent where persons lack capacity will be followed for residents assessed to lack capacity. Staff meeting both of the following criteria will be eligible to provide data on the staff measures for this trial: 1. Be a permanent, contracted, agency or bank member of staff at data collection 2. Have sufficient proficiency in English to contribute to data collection required for the research. To be eligible to provide proxy data (i.e, Quality of Life) on a resident, carers must meet both of the following criteria: 1. Visit the care home on a regular basis over the past month (i.e. usually at least once per fortnight) and be available during the week of data collection 2. Be appropriately consented To be eligible to provide proxy data on a resident, staff must meet all of the following criteria: 1. Be a permanent or contracted member of staff 2. Know the resident well, as assessed by their key worker status and/or the judgement of the home manager 3. Indicate their willingness to providing data for the study by returning the Staff Screening Questionnaire (SSQ) To be eligible to be a mapper on the trial staff must meet all of the following criteria 1. Be a permanent or contracted member of staff 2. Be appropriately consented Previous inclusion criteria: Care homes: 1. Have a minimum of 24 permanent residents 2. Have 60%+ permanent residents with dementia based on a formal diagnosis or Functional Assessment Stagin
Exclusion criteria
Exclusion criteria: Care homes meeting any of the following criteria will not be eligible for this trial: 1. Be, in the view of the researchers, not suitable for inclusion due to being subject to CQC enforcement notices, admission bans or relevant moderate or major CQC compliance breaches 2. Receive other special support for specific quality concerns; such as be currently subject to or have pending, serious safeguarding issues/investigations; receiving other voluntary or compulsory admissions bans; be in receipt of local commissioning special support special support for due to quality concerns 3. Have used DCM as a practice development tool within the last 18 months prior to randomisation 4. Be taking part, have recently taken part in, or be planning to take part, in another trial that conflicts with DCM or with the data collection during the course of their involvement in DCM-EPIC Residents meeting any of the following criteria will not be eligible for this trial: 1. Be terminally ill i.e. formally admitted to an end of life care pathway or permanently bed-bound due to late stage dementia and unable/with limited ability to clearly to communicate distress Staff meeting any of the following criteria will not be eligible to provide data on staff measures for this trial: 1. Be acting as a personal nominee for any resident participant in the trial Staff meeting any of the following criteria will not be eligible to provide proxy data on a resident for this trial: 1. Be acting as a personal nominee for any resident participant in the trial 2. Be a trained Dementia Care Mapper and be using DCM for the purposes of this trial Staff meeting any of the following criteria will not be eligible to be a mapper on the trial 1. Be acting as a personal nominee for any resident participant in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohen Mansfield Agitation Inventory (CMAI); Timepoint(s): Baseline, 6 and 16 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DEMQoL Proxy; Timepoint(s): Baseline, 6 and 16 months 2. EuroQol Group (EQ-5D); Timepoint(s): Baseline, 6 and 16 months 3. Neuropsychiatric Inventory (NPI-NH); Timepoint(s): To investigate if the intervention is effective in reducing Behaviours Staff find Challenging 4. Pittsburgh Agitation Scale; Timepoint(s): Baseline, 6 and 16 months | — |
Countries
United Kingdom
Outcome results
None listed