Condition category
Mental and Behavioural Disorders
Date applied
15/02/2010
Date assigned
06/04/2010
Last edited
24/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.challengedemcare.com

Contact information

Type

Scientific

Primary contact

Ms Cathryn Hart

ORCID ID

Contact details

Humber NHS Foundation Trust
Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A cluster randomised trial of a dementia challenging behaviour web-based training and decision support system, for staff working in residential and nursing homes.

Acronym

Challenge ResCare

Study hypothesis

Principle research question:
Does the experimental intervention reduce the frequency and severity of 'behaviours that challenge' in care homes?

Secondary research questions:
Does the experimental intervention:
1. Reduce the emotional impact of 'behaviours that challenge' on care home staff?
2. Result in care home staff having a more positive and person-centred attitude to people with dementia?
3. Improve staff self-efficacy in caring for people with dementia?
4. Enhance quality of life in care home residents as a whole (including those without dementia)?
5. How cost-effective is the experimental intervention in terms of:
5.1 reducing 'behaviours that challenge';
5.2. its cost per Quality Adjusted Life Year (QALY) relative to usual care?

Ethics approval

The York NHS Research Ethics Committee, 12/05/2009, ref: 09/H1311/29

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

1. Intervention arm: participants in the experimental arm (i.e. all residents in homes randomised to receive the intervention) will be cared for under a regime in which care staff have:
1.1. Access to the web-based training and decision support system designed for the trial
1.2. Continued access to the web-based system to guide their care plans for residents with challenging behaviour during the trial
2. Control arm: participants living in homes allocated to the control arm will receive long term care from care staff 'as usual'. Staff working in these homes may have access to training materials, as they would do usually, available commercially and from organisations such as the Alzheimer's Society as well as training courses that are offered by a variety of providers. Information on such training will be recorded and collated.

Total duration of intervention and follow-up is 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Neuropsychiatric Inventory with Caregiver Distress Scale (NPI−D) This is a validated measure based on informant interview and designed to rate frequency, severity and caregiver distress for 12 Challenging Behaviour categories - delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour, sleep, appetite/eating disorders. The primary research question will be addressed by analysis of the frequency and severity scores.
Outcome will be measured at baseline, 4 months and 12 months

Secondary outcome measures

Secondary outcome measures as of 24/02/2016:
1. Staff and resident quality of life is measured using the Euroqol−5D (EQ−5D)
2. Resident quality of life is measured using the Quality of Life in Alzheimer's Disease (QOL−AD)
3. Diagnostic criteria for dementia is measured using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM−IV)
4. Frequency and severity of challenging behaviour in residents is measured using the Challenging Behaviour Scale (CBS)
5. Attitudes of staff towards people with dementia is measured using the Attitudes to Dementia Questionnaire (ADQ)
6. Perceived effectiveness of staff in caring for people with dementia is measured using the Self−Efficacy Scale
7. Resident health and social care resource use is measured using the (Adapted) Client Service Receipt Inventory (CSRI)
8. Resident medication use is measured using the Structured Medication Inventory (SMI)
9. Clinical Dementia Rating (CDR) is used as a covariate for analysis
10. Emotional impact of, or reaction to, challenging behaviour is measured using the Maslach Burnout Inventory (MBI) and the NPI caregiver distress score
11. Frequency and severity of challenging behaviour in residents is measured using the Cohen-Mansfield Agitation Inventory (CMAI)
12. Staff learning style is measured using the Visual Auditory Kinesthetic (VAK) Learning Styles Self-Assessment Questionnaire

All outcomes will be measured at baseline, 4 months and 12 months

Original secondary outcome measures:
1. Euroqol−5D (EQ−5D)
2. Quality of Life in Alzheimer's Disease (QOL−AD)
3. Short Form 12 (SF−12)
4. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM−IV)
5. Challenging Behaviour Scale (CBS)
6. Attitudes to Dementia Questionnaire (ADQ)
7. 12 Item General Health Questionnaire (GHQ−12)
8. Self−Efficacy Scale
9. (Adapted) Client Service Receipt Inventory (CSRI)
10. Structured Medication Inventory (SMI)
11. Clinical Dementia Rating (CDR)
All outcomes will be measured at baseline, 4 months and 12 months

Overall trial start date

01/02/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Identification of homes (clusters):
Within the trial area, an invitation to participate in the trial will be sent to all care homes with 25+ beds listed on the website of the Care Quality Commission (CQC) as old age care homes, with a rating of 'good' or 'excellent', (a) with nursing care and (b) without nursing care. Homes specialising in care of residents with dementia will not be excluded.
2. Consent of care home residents

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1200 residents (624 with dementia and challenging behaviour)

Participant exclusion criteria

1. Residents whose stay in the home is not, in the judgement of the home manager, likely to be for long term care - for example those receiving respite care
2. Residents who are in the palliative stages of a disease at the time of recruitment
3. Residents who are unable to speak/understand English
4. Residents who enter the home part way through the study or who are out of the home (for example in hospital) at the time of data collection

Recruitment start date

01/03/2011

Recruitment end date

23/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Humber NHS Foundation Trust
Willerby
HU10 6ED
United Kingdom

Sponsor information

Organisation

Humber NHS Foundation Trust (UK)

Sponsor details

Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.humber.nhs.uk/templates/Homepage.aspx?id=1783

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) - programme grant (ref: NIHR RP−PG−1067)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/02/2016: The overall trial end date has been updated from 31/01/2012 to 31/01/2012 and the recruitment dates have been updated from 01/02/2010 - 31/01/2012 to 01/03/2011- 23/03/2012. In addition, the secondary outcome measures and study contact address have also been amended.