Challenge FamCare: Behaviours that challenge in dementia care

ISRCTN	ISRCTN58876649
DOI	https://doi.org/10.1186/ISRCTN58876649
Protocol serial number	N/A
Sponsor	Humber NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK)

Submission date: 17/02/2010
Registration date: 06/04/2010
Last edited: 19/10/2017

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

Prof Esme Moniz-Cook
Scientific

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

Study information

Primary study design	Observational
Study design	Observational naturalistic cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Challenge FamCare: An observational study of people with dementia and challenging behaviour living at home and their carers
Study acronym	Challenge FamCare
Study objectives	As of 24/02/2016: The main aims are to investigate the following questions in respect to people with dementia and challenging behaviour (CB) living at home, supported by a carer. Research questions: 1. Do levels of reported CB, and carer reaction to this, change over time as measured by the frequency and reaction domains of the RMBPC? 2. What is the level of specialist support provided to families, measured by the number of specialist mental health care service contacts and time spent with the family? 3. What are the predictors of change in CB in family care settings? 4. What are the patterns of health and social care service use and associated costs? 5. What are the estimated extent and costs of family care? 6. What are the patterns of prescribing medications measured by change over time, for people living at home with dementia and CB and their carers, and the costs of these? Original study hypotheses: Using a web-based training and decision support system will: 1. Enhance the quality of life of people with dementia and their relationship with their family caregiver 2. Reduce the frequency and severity of challenging behaviours 3. Reduce the level of carer distress associated with challenging behaviours 4. Improve coping and effectiveness in the family carer 5. Be cost effective in terms of reducing challenging behaviour and its cost per Quality Adjusted Life Year (QALY) relative to usual care
Ethics approval(s)	Approval for revised protocol: National Research Ethics Service Committee Yorkshire & The Humber – Leeds West, 22/11/2013 Initial approval: National Research Ethics Service, York Research Ethics Committee, Learning and Research Centre, York Hospital, 12/05/2009, ref: 09/H1311/28
Health condition(s) or problem(s) studied	Dementia with behaviours that challenge
Intervention	Interventions as of 24/02/2016: A cohort of people with a dementia and challenging behaviour and their carers in six NHS organisations, was followed up over a six month period. The information collected focussed specifically on challenging behaviour in family care settings, the stress experienced by family carers, the quality of life of people with dementia and their carers and the range, frequency and cost of health and social care services (including prescribing) accessed by participants recruited to the study. Original interventions: Community Mental Health Nurses (CMHNs) whose team has been randomised will use a functional analysis-based intervention (i.e., web-based training and decision support system) to support carers of people with dementia who display behaviours that challenge. The randomised control group will have treatment as usual from the CMHN.
Intervention type	Other
Primary outcome measure(s)	Primary outcome measure as of 24/02/2016: Revised Memory and Behaviour Problem Checklist (RMBPC) frequency and RMBPC reaction. Original primary outcome measures: Incidence of behaviours that challenge, quality of life and stress and burden measured by: 1. Revised Memory and Behaviour Problem Checklist (RMBPC) 2. Euroqol-5D (EQ-5D) 3. Quality Of Life in Alzheimers Disease (QOL-AD) 4. Short Form-12 (SF-12,) 5. Quality of Relationships (QoR) Scale 6. Neuropsychiatric Inventory including Caregiver Distress Scale (NPI-D) 7. Clinical Dementia Rating (CDR) 8. (Adapted) General Health Questionnaire - 12 9. Hospital Anxiety and Depression scale (HADS) 10. The Short Sense of Competence Questionnaire (SSCQ) 11. Guilt Scale Relatives Stress Scale (RSS)
Key secondary outcome measure(s)	Secondary outcome measures as of 24/02/2016: 1. Frequency and severity of CB assessed using the NPI, with its caregiver distress domain 2. Emotional impact of CB on carers using: the NPI distress score where carers report how distressing they find a CB; the 17-item Guilt Scale; the Hospital Anxiety and Depression Scale and the 12-item General Health Questionnaire (GHQ-12) 3. Coping and effectiveness in caring for someone with CB using the Short Sense of Competence Questionnaire (SSCQ), and the Relative Stress Scale which measures stress specific to dementia caregiving 4. Quality of life of the person with dementia using the European Quality of Life-5 Dimensions (EQ-5D) with its Index and Visual Analogue Scale (VAS) scorings, in which participants are able to indicate their health; the Quality of Life in Alzheimer’s Disease (QOL-AD), and the ICEpop CAPability measure for older people (ICECAP-O) where those people who are able to can report on their perceived quality of life (for EQ-5D and QOL-AD the carers also provide their perception of the person with dementia’s quality of life - proxy report); and the quality of relationship, assessed by both the person with dementia and the carer using the Quality of Caregiver/Patient Relationship (QCPR) scale 5. Quality of life of the carer using: EQ-5D using the Index scoring, ICECAP-O and QCPR 6. Costs in relation to CB using: the adapted Client Service Receipt Inventory (CSRI) to establish the level of health and social care services and medication being accessed for the couple 7. Specialist mental health service contacts: data were collected retrospectively from patient administration systems about the number and duration of contacts with all mental health practitioners over the six month period in which participants were in the study Original secondary outcome measures: To examine cost effectiveness of intervention tool measured by: 1. Client Service Receipt Inventory (CSRI) 2. Structured Medication Inventory (SMI)
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	180
Key inclusion criteria	1. People fulfilling the DSM-IV diagnostic criteria for dementia that have a positive score of 5 or more on the Revised Memory and Behaviour Problem Checklist (RMPBC) 2. Community dwelling with a family or unpaid carer with whom they have regular contact who is a willing participant and informant 3. There are no age limits for participants
Key exclusion criteria	1. Participants with dementia residing in a care home or in receipt of in-patient respite care at the time of recruitment 2. In receipt of palliative or end of life care 3. Non-English speaking
Date of first enrolment	01/02/2010
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Rehabilitation

Kingston Upon Hull
HU3 2PG
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

19/10/2017: Publication reference added.
24/02/2016: The study has been extensively updated to reflect the change from an interventional multi-centre cluster randomised controlled trial to an observational cohort study. The interventions, outcome measures, scientific title and target number of participants have therefore been updated to reflect these changes. The overall trial end date has been updated from 31/01/2012 to 31/12/2013 and the ethical approval for the amended study design was received on 22/11/2013.