Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PCC1040C Moniz-Cook
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
31/05/1998
Overall trial end date
31/10/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients over the age of 65 years who were diagnosed with an 'early dementia in a Memory Clinic'.
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
31/05/1998
Recruitment end date
31/10/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Psychology (Older Adults)
Hull
HU3 2SG
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list