Clinical trial NCT00554047: Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia
Official title: Effectiveness and Costs of Post-diagnosis Treatment in Dementia Coordinated by Multidisciplinary Memory Clinics in Comparison to Treatment Coordinated by General Practitioners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Caregivers
Costs and cost analysis
Multicenter study
Randomized controlled trial
Quality Adjusted Life Years
Quality of life
Technology assessment, biomedical; Methods
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Netherlands Alzheimer Foundation
name: Amsterdam UMC, location VUmc
name: Maastricht University Medical Center
name: Karolinska Institutet
name: Stockholm Health Economics AB
name: Slingeland Hospital
name: Elkerliek Hospital
name: Ggz Oost Brabant
name: Rijnstate Hospital
First posted: 2007-11-06
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proxy-rated Health Related Quality of Life of the patient (cpQol-AD)
timeFrame: at 0, 6 and 12 months
measure: Informal caregivers burden (Sense of competence (SCQ))
timeFrame: at 0, 6 and 12 months
measure: Cost utility analysis (EQ 5D)
timeFrame: at 0, 6 and 12 months
Secondary outcomes:
measure: Geriatric Depression Scale (GDS-15)
timeFrame: at 0, 6 and 12 months
measure: Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS)
timeFrame: at 0, 6 and 12 months
measure: Quality of Live AD caregiver (cQoL-AD)
timeFrame: at 0, 6 and 12 months
measure: Neuro Psychiatric Inventory (NPI-Q)
timeFrame: at 0, 6 and 12 months
measure: Functional performance patient (IDDD)
timeFrame: at 0, 6 and 12 months
measure: Patients rated Health Related Quality of Life (pQol-AD)
timeFrame: at 0, 6 and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center, Alzheimer Centre
city: Arnhem
country: Netherlands
facility: Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics
city: Boxmeer
country: Netherlands
facility: GGZ Oost Brabant, Department of Geriatrics
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital, Department of Geriatrics
city: Ede
country: Netherlands
facility: Hospital Gelderse Vallei, Department of Geriatrics
city: Eindhoven
country: Netherlands
facility: Catharina hospital, Department of Geriatrics
city: Helmond
country: Netherlands
facility: Elkerliek Hospital, Department of Geriatrics
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht, Alzheimer Centre
city: Nijmegen
country: Netherlands
facility: University Medical Centre St Radboud, Alzheimer Centre
Study officials:
affiliation: University Medical Centre St Radboud, Nijmegen
name: Prof. Dr. M. Olde Rikkert, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.