Early Psychosocial Intervention: Through A Memory Clinic: A Randomised Controlled Trial

ISRCTN	ISRCTN87956732
DOI	https://doi.org/10.1186/ISRCTN87956732
Secondary identifying numbers	PCC1040C Moniz-Cook

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 19/09/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Esme Moniz-Cook
Scientific

Department of Clinical Psychology (Older Adults)
University of Hull/Hull and East Riding Community Health NHS Trust
c/o The Coltman Street Day Hospital
Coltman Street
Hull
HU3 2SG
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	The aim of this study was to replicate a previous pilot (Moniz-Cook et al 1998) within a randomised controlled designed. In the pilot study, families recruited to a Community Primary Care led Memory Clinic were taught early memory management crisis preventive strategies over six sessions following diagnosis, and then offered crisis preventive support. At 18 month follow-up the experimental group did better on patient, caregiver and services outcomes. Question: Can early psychosocial intervention offered to older people with dementia and their families, through a Community Memory Clinic, improve their quality of life?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous system diseases: Dementia
Intervention	Following the memory clinic assessment, all families met with the team (psychiatrist or psychologist and a nurse) to discuss the diagnosis and receive advice on future management. Following this, they were randomised to the experimental condition, 'memory clinic' early psychosocial intervention group for support by a memory clinic nurse, or to the 'usual care group' - psychogeriatric community multidisciplinary team, for support by a community psychiatric nurse (CPN). The independent University of York Telephone Randomisation Service allocated patients to each group using the following stratification criteria: MMSE scores (i.e. above and below MMSE 22) and 'domestic situation' (i.e. living with or without a caregiver). The design was essentially pragmatic in order that it could be easily extrapolated to NHS practice. Case audit of 'usual' practice for the control group was compared with what occurred in the experimental group, to explore 'what works for who?' The memory clinic 'early intervention' multi-component programme was individualised to patient and family need and included: 1. Psycho-education and further discussion of the impact of diagnosis on day to day life with management advice, including a written individualised crisis preventive advice booklet. 2. A home-based crisis preventive memory management programme. 3. A behavioural depression-prevention programme. 4. Monitoring of physical health in families. 5. Review of psychotropic medication. 6. Arranging practical and social services if necessary.
Intervention type	Other
Primary outcome measure	Patient Measures: The Mini-Mental State Examination - Diagnostic Interview Schedule (MMSE - DIS) (Folstein et al., 1975). Rivermead Behavioural Memory Test (RMBT) Wilson et al., (1985); Cornell Scale (Depression in dementia), Alexopoulos et al., (1998) H.A.D - Anxiety & Depression, Zigmond, A.S., & Snaith, R.P. (1983); Memory Difficulties Locus of Control Adapted from 'Recovery Locus of Control', Partridge & Johnston (1989). Caregiver Measures: Problem Behaviour checklist, Gilleard, C. (1984); Revised Memory and Behaviour Problem Checklist, Teri L. et al., (1992); H.A.D. - Anxiety & Depression, Zigmond, A.S., & Snaitth, R.P. (1983). General Health Questionnaire - 28 (GHQ - 28), Goldberg, D. (1981). Short Sense of Competence Scale, Vernooij-Dassen et al., (1997). Services Measures: Psychosocial Intervention Checklist 0 an independently rated questionnaire on observed use of psychosocial support; case note audit of number and types of nurse contacts and families and audit of medication prescriptions from GP's.
Secondary outcome measures	Not provided at time of registration
Overall study start date	31/05/1998
Completion date	31/10/2000

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Patients over the age of 65 years who were diagnosed with an 'early dementia in a Memory Clinic'.
Key exclusion criteria	1. Patients below 65 years of age 2. Prescription of anti-dementia drugs, e.g. Aricept, Exelon 3. Longstanding Receipt of Social Service Care 4. Presence of premorbid enduring mental health problems/chronic mood problems, and thus, previous (or ongoing) contact with psychiatric services 5. Onset of dementia greater than 4 years and Mini-Mental State Examination (MMSE) score <14
Date of first enrolment	31/05/1998
Date of final enrolment	31/10/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Clinical Psychology (Older Adults)

Hull
HU3 2SG
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

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