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NCT Number: NCT00554047

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

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.

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU Medical Center, Alzheimer Centre, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Multidisciplinary Memory Clinic

Other

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

General Practitioners

Other

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

Primary outcomes

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

    Time frame: at 0, 6 and 12 months

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

    Time frame: at 0, 6 and 12 months

  3. Cost utility analysis (EQ 5D)

    Time frame: at 0, 6 and 12 months

Secondary outcomes

  1. Geriatric Depression Scale (GDS-15)

    Time frame: at 0, 6 and 12 months

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

    Time frame: at 0, 6 and 12 months

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

    Time frame: at 0, 6 and 12 months

  4. Neuro Psychiatric Inventory (NPI-Q)

    Time frame: at 0, 6 and 12 months

  5. Functional performance patient (IDDD)

    Time frame: at 0, 6 and 12 months

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

    Time frame: at 0, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Elkerliek Hospital
  • Ggz Oost Brabant
  • Karolinska Institutet
  • Maastricht University Medical Center
  • Netherlands Alzheimer Foundation
  • Rijnstate Hospital
  • Slingeland Hospital
  • Stockholm Health Economics AB
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: AD-Euro

Important dates

Study start
2007
Study completion
2010
First posted
Nov 6, 2007
Registry last updated
Jan 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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