Plain English Summary
Not provided at time of registration
Trial website
http://www.ucl.ac.uk/mental-health-sciences/Current%20research/SHIELD.htm
Contact information
Type
Scientific
Primary contact
Prof Martin Orrell
ORCID ID
Contact details
UCL
Department of Mental Health Sciences
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
-
m.orrell@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Phase II, cluster-randomised controlled trial of home-based interventions delivered using the Home Treatment Programme Advisory protocol for people with dementia
Acronym
SHIELD HTP
Study hypothesis
Those people with dementia supported at home and receiving interventions delivered using the HTP Advisory protocol will have significantly better quality of life than those receiving treatment as usual.
Ethics approval
Not provided at time of registration
Study design
Phase II multicentre pragmatic single blind cluster randomised controlled exploratory trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not yet available in web format. please use contact details to request a patient information sheet
Condition
Dementia
Intervention
Intervention group
The Home Treatment Package will function as an advisory protocol/care pathway that offers guidance on appropriate interventions for home treatment and will consist of a structured approach to need assessment and include a combined risk assessment and care-planning tool. The HTP advisory protocol will be based on the evidence collected through the Cochrane and systematic review undertaken as part of Home Treatment Programme work package 1, along with the scoping exercise of existing home treatment teams and expert and service user consultation processes undertaken as part of Home Treatment Programme work package 2. The home treatment interventions will target the needs identified for the person with dementia and their family caregiver and will include a range of approaches, such as intensive support from a mental health keyworker for observation and monitoring of the home situation, provision of increased homecare support services, access to community based services, physical screening and medical treatment, availability of aids and adaptations including the use of assistive technology, respite services, carer education, skills training, counselling and family centred therapy. The HTP advisory protocol will be compiled into a manual and training provided to the mental health keyworkers who will be providing the interventions.
Control group
Participants randomised to the control groups will receive treatment as usual (TAU). Treatment as usual implies the person with dementia and the family caregiver will receive an acceptable standard of care as currently provided within existing Home Treatment Team (HTT) and Community Mental Health Team (CMHT) teams. Treatment as usual will therefore reflect currently accepted practice and participants will continue to receive treatment as usual from statutory and voluntary services within their locality.
The duration of the intervention is 12 months
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
1. Quality of life (QoL) for people with dementia
2. Number of admissions to hospital (both psychiatric and medical)
3. Number of inpatient days
4. Time until care home placement
5. Met and unmet needs for the person with dementia
Outcomes (primary and secondary) will be measured using the following tools
1. Camberwell Assessment of Needs for the Elderly (CANE) (Included in HTP Advisory Protocol)
2. Clinical Dementia Rating (CDR)
3. Mini Mental State Examination (MMSE)
4. Quality of Life - Alzheimer's Disease (QoL-AD)
5. EQ-5D - Patients with Dementia (PWD)
6. EQ-5D - Family carer
7. Cornell depression scale in dementia
8. Rating for Anxiety in Dementia (RAID)
9. Neuro Psychiatric Inventory (NPI)
10. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
11. Hospital Anxiety Depression Scale (HADS)
12. General Health Questionnaire (GHQ-12)
13. Practitioner Assessment of Network Typology (PANT) (Grant & Wenger, 1993)
14. Client Service Receipt Inventory (CSRI)
All outcomes will be assessed at baseline, 3, 6 and 12 months.
Secondary outcome measures
1. Mood
2. Behaviour
3. Activities of daily living
4. Service use and support networks of the person with dementia
All outcomes will be assessed at baseline, 3, 6 and 12 months.
Overall trial start date
01/04/2010
Overall trial end date
01/09/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinical centres
1.1. Have a minimum of 2 clinical areas that can be recruited to the Home Treatment Trial
1.2. Be staffed by appropriately qualified and trained mental health staff such as registered mental health nurses, occupational therapists, social workers and psychologists.
1.3. Provide mental health assessment and treatment to people with dementia
1.4. Have access to psychiatric inpatient beds
1.5. Be currently open to new referrals for people with dementia requiring mental health assessment and treatment
1.6. Be willing to provide the HTP Advisory Protocol as part of the exploratory trial (minimum involvement - 80% of staff members)
2. Participants
2.1. Meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSMIV) criteria for dementia (American Psychiatric Association [APA], 1994) including Alzheimers disease, vascular dementia, Lewy Body type dementia, atypical and mixed dementia
2.2. A Mini Mental State Examination (MMSE) score <24 that indicates the presence of cognitive impairment (Folstein et al, 1975)
2.3. Have a family caregiver / informant (e.g. family member, neighbour, care home staff member) willing to participate in the study
2.4. Have a family caregiver / informant (e.g. family member, neighbour, care home staff member) who provides care for a minimum of 4 hours per week
2.5. Have a mental health keyworker willing to participate in the study
2.6. Have an appropriately qualified mental health keyworker involved in their care i.e. mental health nurse, occupational therapist, psychologist, social worker
2.7. Both the person with dementia and their caregiver live within the geographical areas covered by the research
2.8. The person with dementia and their caregiver will be English-speaking
2.9. Have the potential to benefit from HTP Advisory Protocol interventions - implementation of the HTP Advisory Protocol should not be detrimental to the person with dementias wellbeing, such as by delaying hospital admission for those requiring immediate access to inpatient care
2.10. Male or female, age >65 years
2.11. In addition all participants will meet one of the following criteria:
2.11.1. Are at serious risk of requiring hospital admission within the next month
2.11.2. Meet criteria for admission to an inpatient psychiatric unit
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Clinical centres
1.1. Mental Health settings that do not routinely care for people with dementia
1.2. Non NHS settings, such as voluntary sector services
1.3. Unable to nominate a suitably qualified and experienced senior staff to provide a clinical lead to support the mental health keyworkers
1.4. Unable to nominate a suitably qualified and experienced senior staff to provide a research lead to support the mental health keyworkers
2. Participants
2.1. Have a diagnosis of a learning disability
2.2. Are experiencing acute mental health distress that warrants detention under the mental health act
2.3. Are refusing to accept Home Treatment interventions
2.4. The person with dementia or their family caregiver is already taking part in an existing research study involving psychosocial interventions
Recruitment start date
01/04/2010
Recruitment end date
01/09/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UCL, Department of Mental Health Sciences
London
W1W7EJ
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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