OBJECTIVES: To determine, given a societal perspective, MMCs' effectiveness and costs in post-diagnosis care for dementia-patients to improve or stabilize patient's health related quality of life and performances in daily living and to…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY OUTCOME MEASURES: Patients: Health-related quality of life as measured
with a dementia specific HrQoL-instrument (i.e. QoL-AD) and functional
performance in daily living as measured by the IDDD (Instrumental activities of
Daily living in Dementia Diagnosis); Informal caregivers: caregiver burden as
measured with the Sense of Competence Questionnaire (SoCQ).
Costs will be assessed from a societal perspective, using the Resource
Utilization in Dementia-questionnaire (RUD), which has been used in several
other economic evaluations in AD treatment.
See page 14-15 from the protocol for a detailed description
Secondary outcome
SECONDARY OUTCOME MEASURES:
PATIENTS:
1. Behavioural disturbances will be measured using the NeuroPsychiatric
Inventory (NPI; Cummings, 1994).
2. Cognition will be measured with the MMSE (Folstein et al, 1975). This is a
brief, widely used test of cognitive function, with good reliability and
validity. Another cognition oriented secondary outcome variable is the
Alzheimer*s Disease Assessment Scale - Cognition (ADAS-Cog; Rosen et al, 1984);
this is a more sensitive scale measuring cognitive function and including more
items that assess short-term memory. It is frequently used in drug trials as
the principal cognitive measure, allowing the effects of this intervention to
be compared with antidementia drug trials.
3. Depression. The Cornell Scale for Depression in Dementia (Alexopoulos et al,
1988) rates depression in five broad categories (mood-related signs,
behavioural disturbance, physical signs, biological functions and ideational
disturbance) using information from interviews with staff and participants.
Good reliability and validity have been demonstrated.
4.Weight, which is easy to measure, and is a valid and reliable global measure
of mental and physical well-being.
CAREGIVERS:
1.Mood and anxiety will be measured using the Hospital and Anxiety Depression
Scale (HADS, Spinhoven, 1997), which is translated and validated in Dutch.
2. Satisfaction with care will be measured as we also did in an earlier study
on MMCs (vHout, 2001).
3. Quality of life will also be rated for caregivers looking at their own
quality of life with the Caregiver-Qol, derived from the QOL-AD (Selwood,
2005).
Background summary
BACKGROUND: 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 co-ordination 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 co-ordination, 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
Study objective
OBJECTIVES: To determine, given a societal perspective, MMCs' effectiveness and
costs in post-diagnosis care for dementia-patients to improve or stabilize
patient's health related quality of life and performances in daily living and
to improve informal caregiver's perceived burden of care.
The objective of the MTAannex study will be to study the course and reliability
of quality of life measures in dementia in relation to quality of life measures
registered from caregivers in order to provide an advice on how to best apply
quality of life measures in dementia in future projects.
Study design
STUDY DESIGN: Controlled, randomized study on effectiveness and costs, in which
228 patients are randomised over intervention and control condition.
Intervention
INTERVENTION: Multidisciplinary Memory Clinics (MMCs) will deliver 12 months of
post-diagnosis treatment and care, which consists of:
1. Initiating, targeting and monitoring acethylcholinesterase inhibitors
(AChI), as regular symptomatic drug treatment in case of Alzheimer*s disease
(AD).
2. Other drug interventions in patients with other types of dementia and/or
psychiatric or somatic co-morbidity.
3. Initiating psychosocial interventions and care-coordination.
CONTROL: In the control group the patients with dementia will be referred back
to the GP after diagnosis has been made, with advices on drug treatment, and on
psychosocial interventions and care-planning. GPs will co-ordinate this care,
but can also refer to a range of other services as they currently do in regular
practice except the MMCs.
Study burden and risks
The burden related to the measurement scales is low: these are all known,
'non-intrusive' questionaires, which altogether ask 2 hours from patient and
caregiver per measurement point.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:
1.The patients fulfil DSM-IV TR criteria for dementia with a Clinical Dementia Rating of 1 or 2 (CDR, Hughes, 1982), and MiniMental State Examination (MMSE) score between 10 and 26.
2. All patients are diagnosed as having dementia in one of the participating 7 MMCs.
3. Each patient has a caregiver who is in touch with the patient at least once a week.
4. Patients and carers gave informed consent for participation in the study.
5. All patients are living independently at the start of the study (not in a nursing home, but they may reside in or next to a home for the aged).
6. Each patient has a specific target for post-diagnosis care as formulated by the MMCs (for example: drug treatment with cholinesterase inhibitors in probabale AD; or specific co-morbidity such as paranaoid delusions which asks for drug treatment, care-coordination and/or psychosocial treatment)
Exclusion criteria
Exclusion criteria
1. Severe behavioural disturbances, such as severe depression and aggression to such an extend that participation in this trial is impossible (as judged by the responsible MMC-specialist).
2. Physical co-morbidity requiring a clear priority for another more somatically oriented therapy.
3. Lack of care/support, which probably will cause insufficient compliance to the intervention and the research protocol.
4. Severe problems in vision and/or hearing that make the collection of research data impossible.
5. Uncomplicated dementia patients, with no wish for symptomatic drug treatment, in whom MMcs have no specific advices or treatment targets, except for the diagnostic disclosure.
6. Expression of unwillingness to participation.
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 |
|---|---|
| CCMO | NL16603.091.07 |