Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02216396
Status:
UNKNOWN
Last Update Posted:
2015-12-04
First Post:
2014-08-04
Brief Title:
A Naturalistic Two-year Cohort Study of Agitation and Quality of Life in Care Homes
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
MARQUE Managing Agitation and Quality of Life Stream 2 A Naturalistic Two-year Cohort Study of Agitation and Quality of Life in Care Homes
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARQUE2
Brief Summary:
One third of the population aged over 65 live and will die with dementia Half of people with dementia experience symptoms of agitation every month Symptoms of agitation include restlessness pacing shouting and verbal or physical aggression Many people with agitation are admitted to care homes as families find they cannot care for them at home Within the care home staff also often find managing people with agitation difficult and they react in a wide range of ways Agitated behaviour takes up staff time and emotional and physical energy but they do not always know how to respond This study is one of the streams in an integrated programme to help tackle agitation in a variety of settings from domestic environments to end of life
Our primary hypothesis is that for people with dementia living in care homes paid carer use of dysfunctional coping strategies predicts lower quality of life in residents with dementia and that this is more so at higher levels of agitation
We will recruit 60-80 care homes residential or nursing homes We will identify all residents with dementia and the care home manager will approach them and their family carers After obtaining informed consent or advice from personal or nominated consultees for those lacking capacity we will ask people with dementia who can answer questions about their quality of life using the DEMQOL We will also ask staff and their family carers for those who have them to rate the quality of life of the person with dementia using the DEMQOLproxy We will ask care home staff other questions about residents with dementia including about agitation using the Cohen-Mansfield Agitation Inventory CMAI and the care they receive Staff will also answer questions about the ways they cope with caring stresses using the COPE We will measure quality of life and agitation 5 times over 16 months We will use our results to test our theory that agitation is an important factor determining residents quality of life and that the ways staff cope with stress affect the impact agitation has on quality of life
Our primary hypothesis is that for people with dementia living in care homes paid carer use of dysfunctional coping strategies predicts lower quality of life in residents with dementia and that this is more so at higher levels of agitation
We will recruit 60-80 care homes residential or nursing homes We will identify all residents with dementia and the care home manager will approach them and their family carers After obtaining informed consent or advice from personal or nominated consultees for those lacking capacity we will ask people with dementia who can answer questions about their quality of life using the DEMQOL We will also ask staff and their family carers for those who have them to rate the quality of life of the person with dementia using the DEMQOLproxy We will ask care home staff other questions about residents with dementia including about agitation using the Cohen-Mansfield Agitation Inventory CMAI and the care they receive Staff will also answer questions about the ways they cope with caring stresses using the COPE We will measure quality of life and agitation 5 times over 16 months We will use our results to test our theory that agitation is an important factor determining residents quality of life and that the ways staff cope with stress affect the impact agitation has on quality of life
Detailed Description:
Research questions What is the relationship between paid carer coping and agitation and quality of life in people with dementia living in care homes What are the economic implications What carer resident and environmental characteristics predict better quality of life in this group and should therefore be incorporated into our draft care home intervention before it is evaluated Do agitation quality of life and quality of care predict death Primary hypothesis For people with dementia living in care homes paid carer use of dysfunctional coping strategies predicts lower quality of life in residents with dementia and that this is more so at higher levels of agitation
Methods Setting and sampling We will recruit care homes from across England Our sampling frame will encompass all care homes types where people with dementia reside to ensure external validity and generalisability We will recruit homes to ensure a representation of each provider type voluntary state and private care provision nursing residential and of urbansuburban and rural locations We already carry out research with Jewish Care Dementia UK Camden Adult Social Care Springdene Care Homes group BUPA Care Homes Care UK and Abbey Care We will also work with DeNDRoN ENRICH project CC has been involved in North Thames pilot and our project care home partners Jewish Care BUPA and Barchester to recruit care homes We have discussed with DeNDRoN ENRICH the network has 389 research-ready care homes and is growing rapidly our target is achievable by targeting larger homes including our collaborators BUPA Jewish Care and Barchester There are around 18000 English care homes and 80 of residents have dementia Alzheimers Society
Procedures We will seek care home managers agreement for their care homes inclusion We will note refusal in order to consider external validity and use its predictors in a sensitivity analysis In included homes we will identify through the home care staff which people cared for have dementia using a carer proxy measure the Noticeable Problems Checklist Levin 1989 if they do not have a known dementia diagnosis We will do this rather than screening residents using a cognitive measure as it will not cause distress and is independent of culture and education We will invite all people with dementia to participate Some will be able to give informed consent to take part but the majority are unlikely to have capacity to do so We will follow the Mental Capacity Act 2005 provisions when deciding whether to include people with dementia who do not have capacity and in appointing professional consultees for those without a personal consultee as we have in previous studiesJones et al 2012 We will also interview the consenting primary family carer of each resident included if they see their relative at least monthly and all consenting care team members who provide hands-on care This is to understand the coping strategies used by all who care for them and the impact on residents We will ask the paid carer working most closely with each resident with dementia to complete proxy measures For each home we will record care home characteristics including number of residents in total and with dementia staffing resident ratios turnover and details of regular home activities All assessments will take place at the care home in a private room for paid carers and residents family carers may choose to be interviewed in the care home in their own home or at UCL
Measures Clinical research assistants will conduct interviews at baseline 4 8 12 16 months
Analysis We will test our hypothesis that paid care teams using more dysfunctional coping strategies is associated with people with dementia having a worse subsequent quality of life measured using paid carer DEMQOL and that is more so when their agitation levels are higher We will take into account the influence of agitation and other predefined carer and resident environmental characteristics eg specialist dementia home nursing staff dementia severity resident sex and age Hierarchical multiple regression models will be used to allow for the repeated measurements of quality of life over time and clustering by carer team Interaction terms will be included in the models to consider differential effects of baseline agitation levels We will conduct a cost-consequences analysis reporting by different coping strategies the mean per patient resource use and costs agitation and quality adjusted life years QALYs as measured by the DEMQoL The net monetary benefit calculated as mean per patient costs and QALYs multiplied by the amount a decision maker is willing to pay for a QALY Analysis will also be reported by coping strategy Descriptive statistics of mean per patient costs and resource use by agitation will also be included and will follow a predefined Statistical Analysis Plan SAP We will obtain date and cause of death from the ONS mortality data set the Health and Social Care Information Centre will obtain this data for us by matching NHS number and date of birth against this database
Sample size calculation In our START study the correlation between dysfunctional coping and quality of life was -031 To detect this magnitude of correlation with 90 power 5 significance requires 105 people with dementiaMachin et al 2009 Adjustments to allow for clustering by care team estimated average team size 40 people with dementia Intra cluster correlation ICC 0075Fossey et al 2006 impact of confounding Variance Inflation Factor 2 8 an expected average 25 repeated measurementsperson based on 30 drop outyear and correlation between repeated quality of life measurements of 075 from START data results in a total required sample size of 700 To investigate the interaction between coping strategy and high and low agitation groups will inflate sample size to 2800 This sample size will be reduced if cluster size is less than 40 people with dementia to 1734 people with dementia based on 87 clusters with 20 people with dementia per cluster or to 2000 people with dementia based on 80 clusters with 25 per cluster or to 2537 people with dementia based on 72 clusters with 35 per cluster Although not powered to show outcome we will investigate the responses of family carers and people with dementia in sensitivity analyses
Methods Setting and sampling We will recruit care homes from across England Our sampling frame will encompass all care homes types where people with dementia reside to ensure external validity and generalisability We will recruit homes to ensure a representation of each provider type voluntary state and private care provision nursing residential and of urbansuburban and rural locations We already carry out research with Jewish Care Dementia UK Camden Adult Social Care Springdene Care Homes group BUPA Care Homes Care UK and Abbey Care We will also work with DeNDRoN ENRICH project CC has been involved in North Thames pilot and our project care home partners Jewish Care BUPA and Barchester to recruit care homes We have discussed with DeNDRoN ENRICH the network has 389 research-ready care homes and is growing rapidly our target is achievable by targeting larger homes including our collaborators BUPA Jewish Care and Barchester There are around 18000 English care homes and 80 of residents have dementia Alzheimers Society
Procedures We will seek care home managers agreement for their care homes inclusion We will note refusal in order to consider external validity and use its predictors in a sensitivity analysis In included homes we will identify through the home care staff which people cared for have dementia using a carer proxy measure the Noticeable Problems Checklist Levin 1989 if they do not have a known dementia diagnosis We will do this rather than screening residents using a cognitive measure as it will not cause distress and is independent of culture and education We will invite all people with dementia to participate Some will be able to give informed consent to take part but the majority are unlikely to have capacity to do so We will follow the Mental Capacity Act 2005 provisions when deciding whether to include people with dementia who do not have capacity and in appointing professional consultees for those without a personal consultee as we have in previous studiesJones et al 2012 We will also interview the consenting primary family carer of each resident included if they see their relative at least monthly and all consenting care team members who provide hands-on care This is to understand the coping strategies used by all who care for them and the impact on residents We will ask the paid carer working most closely with each resident with dementia to complete proxy measures For each home we will record care home characteristics including number of residents in total and with dementia staffing resident ratios turnover and details of regular home activities All assessments will take place at the care home in a private room for paid carers and residents family carers may choose to be interviewed in the care home in their own home or at UCL
Measures Clinical research assistants will conduct interviews at baseline 4 8 12 16 months
Analysis We will test our hypothesis that paid care teams using more dysfunctional coping strategies is associated with people with dementia having a worse subsequent quality of life measured using paid carer DEMQOL and that is more so when their agitation levels are higher We will take into account the influence of agitation and other predefined carer and resident environmental characteristics eg specialist dementia home nursing staff dementia severity resident sex and age Hierarchical multiple regression models will be used to allow for the repeated measurements of quality of life over time and clustering by carer team Interaction terms will be included in the models to consider differential effects of baseline agitation levels We will conduct a cost-consequences analysis reporting by different coping strategies the mean per patient resource use and costs agitation and quality adjusted life years QALYs as measured by the DEMQoL The net monetary benefit calculated as mean per patient costs and QALYs multiplied by the amount a decision maker is willing to pay for a QALY Analysis will also be reported by coping strategy Descriptive statistics of mean per patient costs and resource use by agitation will also be included and will follow a predefined Statistical Analysis Plan SAP We will obtain date and cause of death from the ONS mortality data set the Health and Social Care Information Centre will obtain this data for us by matching NHS number and date of birth against this database
Sample size calculation In our START study the correlation between dysfunctional coping and quality of life was -031 To detect this magnitude of correlation with 90 power 5 significance requires 105 people with dementiaMachin et al 2009 Adjustments to allow for clustering by care team estimated average team size 40 people with dementia Intra cluster correlation ICC 0075Fossey et al 2006 impact of confounding Variance Inflation Factor 2 8 an expected average 25 repeated measurementsperson based on 30 drop outyear and correlation between repeated quality of life measurements of 075 from START data results in a total required sample size of 700 To investigate the interaction between coping strategy and high and low agitation groups will inflate sample size to 2800 This sample size will be reduced if cluster size is less than 40 people with dementia to 1734 people with dementia based on 87 clusters with 20 people with dementia per cluster or to 2000 people with dementia based on 80 clusters with 25 per cluster or to 2537 people with dementia based on 72 clusters with 35 per cluster Although not powered to show outcome we will investigate the responses of family carers and people with dementia in sensitivity analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None