Alzheimer's disease Dementia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands