Condition category
Mental and Behavioural Disorders
Date applied
24/02/2010
Date assigned
18/05/2010
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
W1W7EJ
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 below 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 (DSM–IV) criteria for dementia (American Psychiatric Association [APA], 1994) including Alzheimer’s 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 dementia’s 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

Sponsor information

Organisation

North East London NHS Foundation Trust

Sponsor details

Goodmayes Hospital
Barley Lane
Goodmayes
Ilford
IG3 8XJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

04/02/2016: No publications found, verifying study status with principal investigator