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DementiaAD-EuroNCT00554047

Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia

A study testing Multidisciplinary Memory Clinic and General Practitioners in people with Dementia, run by Radboud University Medical Center at 9 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC) currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs are increasingly involved in post-diagnosis treatment and coordination of care, which probably is very important for patients and… Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia
What is being tested?
Multidisciplinary Memory Clinic and General Practitioners
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
9 sitesNetherlands
Study dates
Dec 2007to Jul 2010
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A patient with a new dementia diagnosis made at the MMC of the participating centre fulfilling DSM-IV-TR criteria with a CDR 0.5, 1 or 2
  • Each patient has a caregiver
  • Both patients and caregivers can provide informed consent for participation in the study

Who cannot join

  • Life expectancy less than 1 year
  • Living in a nursing home
  • Already evaluated as being suitable for living in a nursing home
  • Data collection impossible (e.g., due to severe visual/hearing/language impairment, mood disorder, or behavioral disturbances)
  • The patient's general practitioner does not agree to participate
  • Already participating in another study
Show all 13Show fewer
  • The patient visits the MMC for a second opinion
  • Travel distance between MMC and patient's living address more than 50 kilometers
  • A definite indication for memory clinic follow up:
  • A definite need for symptomatic drug treatment as judged by treating physician (e.g., Dementia with Lewy Bodies)
  • A definite need for specialist guidance as judged by treating physician (e.g., Creutzfeldt-Jakob Disease, severe Frontotemporal Lobar Disease)
  • A definite wish for symptomatic drug treatment by patient or caregiver
  • A definite need for guidance from psychiatric services involved in the memory clinic

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Netherlands9 sites

  • VU Medical Center, Alzheimer Centre

    Amsterdam

  • Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics

    Arnhem

  • GGZ Oost Brabant, Department of Geriatrics

    Boxmeer

  • Slingeland Hospital, Department of Geriatrics

    Doetinchem

  • Hospital Gelderse Vallei, Department of Geriatrics

    Ede

  • Catharina hospital, Department of Geriatrics

    Eindhoven

  • Elkerliek Hospital, Department of Geriatrics

    Helmond

  • University Hospital Maastricht, Alzheimer Centre

    Maastricht

  • University Medical Centre St Radboud, Alzheimer Centre

    Nijmegen

Other trials in Netherlands

About this study

Official title: Effectiveness and Costs of Post-diagnosis Treatment in Dementia Coordinated by Multidisciplinary Memory Clinics in Comparison to Treatment Coordinated by General Practitioners

In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC) currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs are increasingly involved in post-diagnosis treatment and coordination of care, which probably is very important for patients and caregivers, but also very time consuming and expensive. This study will focus on the important question whether this complex post-diagnosis treatment and care coordination, evaluated both on effectiveness and costs, should be carried out by MMCs (intervention) or by General Practitioners (GPs) (control) as pivot of delivery of health care for these patients.

Objectives: To determine MMCs' effectiveness and cost-effectiveness in post-diagnosis treatment and care-coordination for dementia-patients and their caregivers compared to the post-diagnosis treatment and care coordination by GPs.

Read more

Time schedule: 12 months for including patients and their caregivers and 12 months of follow-up.

Annex Study: Specifically for the Health Technology Assessment (HTA) methodology study the main study will be extended with some experimental proxy measurements and alternative measurement approaches.

The objective of this Annex-study is to explore the feasibility and validity of Health Related Quality of Life (HRQL) value measurement in dementia patients. And to study the characteristics of proxy rating in HRQL research in dementia and the suitability and validity of yielding HRQL measurements by proxy assessment. Furthermore to explore the validity, reliability, and feasibility of the EQ5D and EQ6D in dementia research (in patients and in/by proxies); response shift, and alternative (more simple) methods of HRQL measurement and validate the Dutch versions of the QOL-AD and the use of the CarerQol-7D in dementia research.

Conditions
Dementia
Being tested
Multidisciplinary Memory Clinic, General Practitioners
Keywords
Dementia, Caregivers, Costs and cost analysis, Multicenter study, Randomized controlled trial, Quality Adjusted Life Years, Quality of life, Technology assessment, biomedical; Methods
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary Memory ClinicOther

    Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)

  • General PractitionersOther

    Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners

Study groups in NCT00554047
Study groupRoleWhat they receive
1ExperimentalMultidisciplinary Memory Clinic
Receives: Other: Multidisciplinary Memory Clinic
2Active comparatorGeneral practitioner
Receives: Other: General Practitioners

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proxy-rated Health Related Quality of Life of the patient (cpQol-AD)

    Measured: at 0, 6 and 12 months

  2. Informal caregivers burden (Sense of competence (SCQ))

    Measured: at 0, 6 and 12 months

  3. Cost utility analysis (EQ 5D)

    Measured: at 0, 6 and 12 months

Secondary outcomes (6)

  1. Geriatric Depression Scale (GDS-15)

    Measured: at 0, 6 and 12 months

  2. Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS)

    Measured: at 0, 6 and 12 months

  3. Quality of Live AD caregiver (cQoL-AD)

    Measured: at 0, 6 and 12 months

  4. Neuro Psychiatric Inventory (NPI-Q)

    Measured: at 0, 6 and 12 months

  5. Functional performance patient (IDDD)

    Measured: at 0, 6 and 12 months

  6. Patients rated Health Related Quality of Life (pQol-AD)

    Measured: at 0, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Study completionJul 2010

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00554047
Sponsor's protocol ID
ADE 072510
Other IDs
ZonMw 80-007022-98-07703, ZonMw 945-07-7039
Acronym
AD-Euro
Status last verified
Aug 2010
First submitted
5 Nov 2007
Last updated
10 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Meeuwsen E, Melis R, van der Aa G, Goluke-Willemse G, de Leest B, van Raak F, Scholzel-Dorenbos C, Verheijen D, Verhey F, Visser M, Wolfs C, Adang E, Olde Rikkert M. Cost-effectiveness of one year dementia follow-up care by memory clinics or general practitioners: economic evaluation of a randomised controlled trial. PLoS One. 2013 Nov 25;8(11):e79797. doi: 10.1371/journal.pone.0079797. eCollection 2013.

    PubMed 24282511

  • Meeuwsen EJ, Melis RJ, Van Der Aa GC, Goluke-Willemse GA, De Leest BJ, Van Raak FH, Scholzel-Dorenbos CJ, Verheijen DC, Verhey FR, Visser MC, Wolfs CA, Adang EM, Olde Rikkert MG. Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial. BMJ. 2012 May 15;344:e3086. doi: 10.1136/bmj.e3086.

    PubMed 22589500

  • Meeuwsen EJ, German P, Melis RJ, Adang EM, Goluke-Willemse GA, Krabbe PF, de Leest BJ, van Raak FH, Scholzel-Dorenbos CJ, Visser MC, Wolfs CA, Vliek S, Rikkert MG. Cost-effectiveness of post-diagnosis treatment in dementia coordinated by Multidisciplinary Memory Clinics in comparison to treatment coordinated by general practitioners: an example of a pragmatic trial. J Nutr Health Aging. 2009 Mar;13(3):242-8. doi: 10.1007/s12603-009-0066-1.

    PubMed 19262961

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary Memory Clinic and General Practitioners in people with Dementia, run by Radboud University Medical Center at 9 sites 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 3 inclusion and 13 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 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Proxy-rated Health Related Quality of Life of the patient (cpQol-AD) (time frame: at 0, 6 and 12 months). The study lists 3 primary outcomes in all. 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 NCT00554047, which also lists 3 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 10 Jan 2011.

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