Challenge ResCare: Behaviours that challenge in dementia care

ISRCTN	ISRCTN02553381
DOI	https://doi.org/10.1186/ISRCTN02553381
Protocol serial number	N/A
Sponsor	Humber Teaching NHS Foundation Trust
Funder	National Institute for Health Research (NIHR) - programme grant (ref: NIHR RP−PG−1067)

Submission date: 15/02/2010
Registration date: 06/04/2010
Last edited: 07/06/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Cathryn Hart
Scientific

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

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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.
Study acronym	Challenge ResCare
Study objectives	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(s)	The York NHS Research Ethics Committee, 12/05/2009, ref: 09/H1311/29
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1200
Key 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
Key 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
Date of first enrolment	01/03/2011
Date of final enrolment	23/03/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Humber NHS Foundation Trust

Willerby
HU10 6ED
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/06/2023: Internal review.
19/10/2017: Publication reference added.
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.