Dementia
Conditions
Keywords
Dementia, Caregivers, Costs and cost analysis, Multicenter study, Randomized controlled trial, Quality Adjusted Life Years, Quality of life, Technology assessment, biomedical; Methods
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.
Interventions
OTHERMultidisciplinary Memory Clinic
Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)
Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Netherlands Alzheimer Foundation
Amsterdam UMC, location VUmc
Maastricht University Medical Center
Karolinska Institutet
Stockholm Health Economics AB
Slingeland Hospital
Elkerliek Hospital
Ggz Oost Brabant
Rijnstate Hospital
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proxy-rated Health Related Quality of Life of the patient (cpQol-AD) | at 0, 6 and 12 months |
| Informal caregivers burden (Sense of competence (SCQ)) | at 0, 6 and 12 months |
| Cost utility analysis (EQ 5D) | at 0, 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Neuro Psychiatric Inventory (NPI-Q) | at 0, 6 and 12 months |
| Geriatric Depression Scale (GDS-15) | at 0, 6 and 12 months |
| Patients rated Health Related Quality of Life (pQol-AD) | at 0, 6 and 12 months |
| Functional performance patient (IDDD) | at 0, 6 and 12 months |
| Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS) | at 0, 6 and 12 months |
| Quality of Live AD caregiver (cQoL-AD) | at 0, 6 and 12 months |
Countries
Netherlands
Outcome results
None listed