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

NCT02216396 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1734

Last updated 2015-12-04

No results posted yet for this study

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

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Claudia Cooper · UCL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216396 on ClinicalTrials.gov