Delirium, Dementia, Amnestic, Cognitive DisordersNCT00402311
The Effects and Cost-Effectiveness of an Integrated Multidisciplinary Approach for Psychogeriatric Patients
A study testing DOC-PG: integrated multidisciplinary assessment in people with Delirium, Dementia, Amnestic, Cognitive Disorders and Memory Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Delirium, Dementia, Amnestic, Cognitive Disorders, Memory Disorders
- What is being tested?
- DOC-PG: integrated multidisciplinary assessment
- Type of treatment
- Surgery or procedure
- How many people
- 216 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2002to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Hospital Maastricht
Maastricht, Limburg, 6202 AZ
About this study
Official title: A Prospective Randomized Trial on the Effects of a Psychogeriatric Diagnostic Day Hospital
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).
Read the detailed 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).
- Being tested
- DOC-PG: integrated multidisciplinary assessment, Usual care: assessment by GP or one of the regional services
- Keywords
- Health Services for the Aged, Geriatric Psychiatry
- Medical subject headings
- Neurocognitive Disorders, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOC-PG: integrated multidisciplinary assessmentProcedure or surgery
Usual care: assessment by GP or one of the regional servicesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale of the EuroQol-5D
Secondary outcomes (9)
Utility score of the EuroQol-5D
Short Form 36 (SF-36)
Mini Mental State Examination (MMSE)
Global Deterioration Scale (GDS)
NeuroPsychiatric Inventory (NPI)
Instrumental Activities of Daily Living scale (IADL)
Cornell Scale of Depression in Dementia (CSDD)
Perceived Pressure from Informal Care (Dutch translation, EDIZ)
Informal care questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startApr 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Delirium, Dementia, Amnestic, Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Frans R Verhey, PhD, MD, Principal investigator, Maastricht University Medical CenterCarmen D. Dirksen, PhD, Study director, Maastricht University Medical CenterJohan L Severens, PhD, Study director, Maastricht University Medical CenterAlfons Kessels, MD, MSc, Study chair, Maastricht University Medical CenterClaire A Wolfs, MSc, Study chair, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402311
- Sponsor's protocol ID
- 945-02-055
- Status last verified
- Nov 2006
- First submitted
- 20 Nov 2006
- Last updated
- 22 Jan 2007
- Results posted
- No
Publications
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. doi: 10.1002/gps.1454.
PubMed 16440403Wolfs 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
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. doi: 10.1002/gps.1666.
PubMed 16977677Wolfs CA, Dirksen CD, Kessels A, Severens JL, Verhey FR. Economic evaluation of an integrated diagnostic approach for psychogeriatric patients: results of a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):313-23. doi: 10.1001/archgenpsychiatry.2008.544.
PubMed 19255381
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial on the Effects of a Psychogeriatric Diagnostic Day Hospital
- ClinicalTrials.gov ID
- NCT00402311
- Acronym / sponsor ID
- 945-02-055
- Keywords
- Health Services for the Aged, Geriatric Psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2002
- Study completion
- Aug 2005
- First posted
- 22 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOC-PG: integrated multidisciplinary assessment | Procedure or surgery | – |
| Usual care: assessment by GP or one of the regional services | Procedure or surgery | – |
Primary outcome
The Visual Analogue Scale of the EuroQol-5D
9 secondary outcomes
Utility score of the EuroQol-5D
Short Form 36 (SF-36)
Mini Mental State Examination (MMSE)
Global Deterioration Scale (GDS)
NeuroPsychiatric Inventory (NPI)
Instrumental Activities of Daily Living scale (IADL)
Cornell Scale of Depression in Dementia (CSDD)
Perceived Pressure from Informal Care (Dutch translation, EDIZ)
Informal care questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2007.
- Background: PubMed 16440403Wolfs 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. doi: 10.1002/gps.1454.
- BackgroundWolfs 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
- Results publication: PubMed 16977677Wolfs 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. doi: 10.1002/gps.1666.
- Derived from this study: PubMed 19255381Wolfs CA, Dirksen CD, Kessels A, Severens JL, Verhey FR. Economic evaluation of an integrated diagnostic approach for psychogeriatric patients: results of a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):313-23. doi: 10.1001/archgenpsychiatry.2008.544.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frans R Verhey, PhD, MD principal investigator
Maastricht University Medical Center
Carmen D. Dirksen, PhD study director
Maastricht University Medical Center
Johan L Severens, PhD study director
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOC-PG: integrated multidisciplinary assessment in people with Delirium, Dementia, Amnestic, Cognitive Disorders and Memory Disorders, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale of the EuroQol-5D. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00402311, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2007.