Challenge ResCare: Behaviours that challenge in dementia care
| ISRCTN | ISRCTN02553381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02553381 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Humber NHS Foundation Trust
Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
United Kingdom
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/02/2010 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1200 residents (624 with dementia and challenging behaviour) |
| 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
- England
- United Kingdom
Study participating centre
Humber NHS Foundation Trust
Willerby
HU10 6ED
United Kingdom
HU10 6ED
United Kingdom
Sponsor information
Humber Teaching NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Trust HQ
Willerby Hill
Beverley Road
Willerby
HU10 6ED
England
United Kingdom
| Website | http://www.humber.nhs.uk/templates/Homepage.aspx?id=1783 |
|---|---|
"ROR" |
https://ror.org/016bnqk64 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) - programme grant (ref: NIHR RP−PG−1067)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
