Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Esme Moniz-Cook

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes