Primary and secondary measures are assessed after the initial planned intervention (first follow-up, M4), at 8 months (second follow-up M8) and at 12 months (third follow-up, M12). All outcomes and the timetable are shown in Table
1.
Table 1
Overview of instruments (measures) in the MatheoAlz trial
MMSE | | ✓ | | | |
NPI | | ✓ | ✓ | ✓ | ✓ |
DAD | | ✓ | ✓ | ✓ | ✓ |
MADRS | | | ✓ | ✓ | ✓ |
Apathy inventory | | | ✓ | ✓ | ✓ |
Zarit | | | ✓ | ✓ | ✓ |
RUD | | | ✓ | ✓ | ✓ |
Sense of competence questionnaire | | | ✓ | ✓ | ✓ |
Apathy Inventory | | | ✓ | ✓ | ✓ |
QOLAD | | | ✓ | ✓ | ✓ |
Primary outcome measure
a) Behavior symptoms are measured with the Neuropsychiatric Inventory (NPI), that assesses the frequency and the severity of the symptoms as well as the caregiver distress in 12 behavioral domains (delusions, hallucinations, depression/dysphoria, anxiety, agitation/aggression, elation/euphoria, disinhibition, irritability/lability, apathy/indifference, aberrant motor activity, sleep/night time behavior, and appetite/eating). NPI is given as an interview questionnaire [
17]. Each domain is rated by the caregiver in terms of both frequency (1–4) and severity (1–3), yielding a composite symptom domain score (frequency×severity). The total composite score is obtained by summing up the single item scores, which may range from 0 to 144, with higher scores indicating more behavioral problems.
Secondary outcomes
b) Quality of life is measured using the Quality of Life-Alzheimer’s disease Scale (QOL-AD) [
18]. The QOL-AD covers 13 domains of quality of life. It has good internal consistency, validity and reliability and its use is recommended by the European consensus on outcome measures for psychosocial interventions in dementia [
19]. The scale presents high psychometrics properties whatever the dementia etiologies [
20].
c) Functional performances are measured with the Disability Assessment in Dementia (DAD). This scale assesses 10 basic and instrumental activities of daily living and decomposed each activity into initiation, organization and efficacy. The sensitivity and reliability have been established [
21].
d) Apathy is measured using the apathy inventory [
22], that assesses emotional fatigue, initiative loss and interest loss. Psychometric properties are good [
23].
e) Depression is assessed using Montgomery-Asberg Depression Rating Scale (MADRS) [
24]. This scale explores 10 dimensions: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The MADRS is one of the most reliable scale to detect depressive symptoms in dementia population independently of the stage of severity [
25].
f) Caregivers’ burden is assessed using the Zarit Burden Index (ZBI) [
26]. The ZBI is a subjective measure of burden that includes 22 items exploring the caregiver’s perception and feelings about care situations.
g) Caregivers’ sense of competence is assessed with the sense of competence questionnaire [
27].
h) Vital status and institutionalization and their dates are assessed at each follow-up using any sources of data available (main caregivers or the general practitioner).
i) Patients’ resource utilization is measured for the month prior to the visit using the Resource Use in Dementia (RUD) [
28]. The RUD questionnaire was specifically designed to estimate formal resource utilization (primary and secondary care consultation, hospitalizations, social care services funded or brokered by local authorities…) as well as informal care for dementia-related activities. Primary caregivers are asked to notify the number of days and time spent for formal and informal caregiving activities provided during the month prior to the visit.
j) Process of care in relation with dementia is assessed by asking caregivers for current use of anti-dementia drug, antidepressant drug, antipsychotic drug, consultation with a specialist (memory clinic, neurologist with private activity, psychiatrist, geriatrician) in the previous 3 months, speech therapist use, presence and type of home help support, financial subsidies support, and adult day care use.