What is the comparative efficacy and safety between dementia diagnostics in primary care and dementia diagnostics in a memory clinic for older persons with memory complaints?
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily functioning using the Amsterdam iADL questionnaire (A-iADL-Q-SV)
Outcomes are measured at baseline and at 6, 18 and (24-)30 months
Secondary outcome
Quality of life
- Behavior and mood
- Caregiver burden and perseverance time
- Acute admissions, time to institutionalization, time to mortality
- Healthcare costs
- Accuracy of the initial diagnosis
- Anxiety or dissatisfaction after diagnostic trajectory
Outcomes are measured at baseline and at 6, 18 and 30 months
Background summary
In The Netherlands, dementia is more often diagnosed in a memory clinic than in
primary care. In a memory clinic, the diagnosis is often made earlier, but the
extensive diagnostic work-up in a memory clinic is often experienced as
burdensome by patients and caregivers. Therefore, it is questionable whether
referral to a memory clinic is in the interest of patients, particularly in the
absence of a disease-modifying treatment. Moreover, memory clinic diagnostics
are more expensive.
HYPOTHESIS: In absence of disease-modifying treatment for dementia, a
diagnostic trajectory in primary care is not inferior to memory clinic
diagnostics with respect to long-term outcomes relevant to patients and
caregivers and generates less healthcare costs
Study objective
What is the comparative efficacy and safety between dementia diagnostics in
primary care and dementia diagnostics in a memory clinic for older persons with
memory complaints?
Study design
Single-center randomized controlled diagnostic trial with a non-inferiority
design (RCT).
Two diagnostic trajectories, both in line with current guidelines for dementia
diagnostics, are compared.
18-11-2024: Addition of a prospective cohort alongside the randomized design.
In the cohort, we include participants who do not wish to be randomized, using
the same outcome measures as in the RCT.
Intervention
Although this is a randomised diagnostic study, we labelled the two diagnostic
trajectories as intervention and control, in line with the ZonMW comparative
effectiveness funding scheme that funded the project
Intervention: dementia diagnostics in primary care
Control: dementia diagnostics in a memory clinic
Study burden and risks
The burden for participants consists of filling out questionnaires together
with a researcher. At baseline this will take 60 minutes. At three follow-up
visits over a period of (24-)30 months, it will take 30-45 minutes during each
visit. The total burden is 150-195 minutes.
Because we compare two diagnostic trajectories which both fall within
prevailing Dutch guidelines, there is no additional burden and there are no
risks to participating in this research.
Geert Grootepolein Zuid 21
Nijmegen 6525EZ
NL
Geert Grootepolein Zuid 21
Nijmegen 6525EZ
NL
Listed location countries
Age
Inclusion criteria
- adults 70 years and over
- memory complaints
Exclusion criteria
- focal signs on neurological examination
- expected uncommon cause of dementia
- strong preference of GP or patient for location of diagnostics (either in
primary care or in memory clinic)
- advanced dementia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN18043557 |
| CCMO | NL83486.091.22 |