Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Esme Moniz-Cook


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Challenge FamCare: An observational study of people with dementia and challenging behaviour living at home and their carers


Challenge FamCare

Study hypothesis

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

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

Study design

Observational naturalistic cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

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


Dementia with behaviours that challenge


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



Not Applicable

Drug names

Primary outcome measures

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 Alzheimer’s 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)

Secondary outcome measures

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)

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

180 people with dementia and their carers (originally: 800 people with dementia and their carer, plus their Community Mental Health Nurse)

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Rehabilitation
Kingston Upon Hull
United Kingdom

Sponsor information


Humber NHS Foundation Trust (UK)

Sponsor details

Willerby Hill
Beverley Road
East Yorkshire
HU10 6ED
United Kingdom

Sponsor type

Not defined



Funder type


Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of a report on this study is part of a NIHR programme grant for applied research. Links to publications will also be on

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 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.