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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00402311
Other study ID # 945-02-055
Secondary ID
Status Completed
Phase N/A
First received November 20, 2006
Last updated January 19, 2007
Start date April 2002
Est. completion date August 2005

Study information

Verified date November 2006
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects and cost-effectiveness of a Diagnostic Observation Center for PsychoGeriatric patients (DOC-PG). Our main hypothesis is that DOC-PG has added value compared with usual care regarding Health Related Quality of Life (HRQoL).


Description:

An integrated multidisciplinary approach to diagnosing and managing dementia is generally recommended, though rarely investigated. In recent years, multidisciplinary memory clinics (MCs) for patients with dementia have been established in many places over the world. These services have recently also been criticised for being principally hospital-based, for their apparently limited focus that entails only medical diagnostics and pharmacotherapy and for thus diverting resources from community mental health teams(CMHTs) .On the other hand, CMHTs are mainly concerned with the provision and organisation of integrated care, and unlike MCs, CMHTs generally have limited access to hospital-based diagnostics such as brain-imaging.

In April 2002, an outpatient diagnostic facility, the Diagnostic Observation Centre for PsychoGeriatric patients (DOC-PG) was established in Maastricht, the Netherlands. DOC-PG combines the hospital-based approach of the MC with the care-oriented approach of the regional CMHT and aims to provide the general practitioner (GP) with elaborate diagnostic and therapeutic advice for patients with cognitive disorders.

Comparison: DOC-PG is compared with usual care i.e. the GP took care of the diagnosis, or he or she referred the patient to one of the separate regional services, e.g. the Maastricht Memory Clinic (MMC), geriatric medicine, or the department of mental health for the elderly of the mental health community service (CMHT).


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Aged 55 years or over

- Suspected of having dementia or combined somatic/psychiatric disorder

- No referral to other local/regional services in the last two years

- Availability of a proxy (visiting the patient at least once a week)

Exclusion Criteria:

- Acute disorders that need a prompt therapeutic intervention

- Living in a nursing home or receiving care that is comparable to that of a nursing home

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
DOC-PG: integrated multidisciplinary assessment

Usual care: assessment by GP or one of the regional services


Locations

Country Name City State
Netherlands Academic Hospital Maastricht Maastricht Limburg

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Wolfs CA, Dirksen CD, Severens JL, Verhey FR. The added value of a multidisciplinary approach in diagnosing dementia: a review. Int J Geriatr Psychiatry. 2006 Mar;21(3):223-32. Review. — View Citation

Wolfs CA, Verhey FR, Kessels A, Winkens RA, Severens JL, Dirksen CD. GP concordance with advice for treatment following a multidisciplinary psychogeriatric assessment. Int J Geriatr Psychiatry. 2007 Mar;22(3):233-40. — View Citation

Wolfs CAG, Severens JL, Dirksen CD, Kessels A, Jaspers N, Verhey FRJ. 2005. A Randomized Clinical Trial on the Effects of a Diagnostic Observation Centre for PsychoGeriatric patients (DOC-PG). International Psychogeriatrics 17: 370-371

Outcome

Type Measure Description Time frame Safety issue
Primary The Visual Analogue Scale of the EuroQol-5D
Secondary Utility score of the EuroQol-5D
Secondary Short Form 36 (SF-36)
Secondary Mini Mental State Examination (MMSE)
Secondary Global Deterioration Scale (GDS)
Secondary NeuroPsychiatric Inventory (NPI)
Secondary Instrumental Activities of Daily Living scale (IADL)
Secondary Cornell Scale of Depression in Dementia (CSDD)
Secondary Perceived Pressure from Informal Care (Dutch translation, EDIZ)
Secondary Informal care questionnaire
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