A Naturalistic Two-year Cohort Study of Agitation and Quality of Life in Care Homes

NCT02216396 | Unknown DMC

• 1 other identifier: 143438
• Study Type: observational
• Target: 1,734
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Agitation

Keywords

dementia; care home; agitation; coping

Outcome Measures

Primary Outcomes (1)

• DEMQOL and DEMQOL proxy

  quality of life of the person with dementia

  Up to 16 months

Secondary Outcomes (6)

• Brief COPE (Coping Orientations to Problems Experienced)

  baseline

• Maslach burnout inventory

  baseline

• revised Modified Conflict Tactics Scale for professional carers

  baseline

• Cohen-Mansfield Agitation Inventory

  0,4,8,12,16 months

• Neuropsychiatric Inventory

  0,4,8,12,16 months

Other Outcomes (3)

• EQ-5D proxy

  0,4,8,12,16 months

• hospitalisations and date and cause of death

  up to 16 months

• Therapeutic Environment Screening Survey for Nursing Homes and Residential Care (TESS-NH/RC)

  0,4,8,12,16 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 urban/suburban and rural locations. There are around 18,000 English care homes and 80% of residents have dementia (Alzheimer's Society). We will include all people with dementia diagnosed or screening positive for possible dementia on the Noticeable Problems checklist, all care home staff who provide care for this population and family carers who are in regular contact.

You may qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Care homes across England

London, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Claudia Cooper

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 15, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 4, 2015

Record last verified: 2015-05

Locations

GB (1)