INTRODUCTION AND RATIONALE It has been estimated that at least 50% of the home living persons with dementia in the Netherlands receive little or no formal care and support (Zorgstandaard Dementie, 2013). Reasons why persons with dementia and their informal caregivers receive no formal care vary, include absence of diagnosis, denial of illness, embarrassment or the complexity of the care and referral system. A common concern among health care professionals is that by the time the person with dementia or informal caregiver do seek or receive formal care it may be too late. The difficulties at home may already be so severe that there is little that community-based care can do and admission to residential care may follow soon after. Appropriate support at an earlier stage may prevent more serious difficulties and postpone admission to residential care. Therefore, health care professionals are looking for strategies to reach persons with dementia and caregivers in an earlier stage of dementia and encourage them to accept some form of help or support. The rationale of this study is to investigate how persons living with dementia and their close others can be encouraged to accept support and whether support at an early stage is effective in preventing severe deterioration in wellbeing, behavioural difficulties and high care costs later on. OBJECTIVES * Estimate the effect of EE on caregiver self-efficacy compared to usual care * Estimate the effect of EE on the total care costs of caregiver and person with dementia compared to usual care * Estimate the cost-effectiveness and cost-utility of EE compared to usual care * Perform a process evaluation to monitor delivery of EE and experiences of persons with dementia, caregivers and care professionals * Explore treatment responsiveness of EE in terms of self-efficacy and quality of life STUDY DESIGN Pragmatic, cluster randomised controlled trial. STUDY POPULATION Informal caregivers and people with early-stage dementia, who are community dwelling and receive little or no dementia-related formal ADL care. INTERVENTION The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group. MAIN STUDY PARAMETERS/ENDPOINTS Primary: self-efficacy. Cost-utility: EQ5D, RUD. Secondary: quality-of-life, caregiver burden. DATA COLLECTION Measurements consist of questionnaires (total duration is approximately 1 hour; administered at home; take place at baseline, 3, 6, and 12 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
102
The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group for persons in the early stage of dementia and their main informal caregiver (e.g. spouse, relative), who receive little or no formal care. The intervention will discuss the effects of dementia, and how to cope and adjust to those effects. It will take place in small group sessions led by a health care professional (e.g. casemanager) and is intended for both the person with dementia and the caregiver. The intervention will be personalised to meet needs, interests and strengths of the dyad by discussing the sessions content at the start of the intervention.
Klinische Neuropsychologie
Amsterdam, North Holland, Netherlands
RECRUITINGCaregiver Self-efficacy Scale (CSES)
The self-efficacy of informal caregivers measured by the Caregiver Self-efficacy Scale (CSES). This domain contains five items that are scored self-rated from 1 (not at all certain) to 10 (very certain) with higher scores indicating better outcomes.
Time frame: 12 months
TOPICS-MDS
Characteristics of the informal caregivers and persons with dementia collected by the TOPICS-MDS questionnaire to capture TOPICS-MDS: demographic characteristics, relation between informal caregiver and person with dementia, perseverance time (informal caregiver) instrumental and personal activities of daily living (person with dementia).
Time frame: 12 months
HADS
Depression and anxiety of informal caregivers measured by the Hospital and Anxiety Depression Scale (HADS). The HADS provides separate scores for depression and anxiety, each with 7 items on a four-point Likert scale ranging from 0 (not at all) to 3 (a great deal of the time). Total scores range from 0 to 21 per complaint, with higher scores indicating more anxiety or depression severity for the informal caregiver.
Time frame: 12 months
ICECAP-O
Quality of life of informal caregivers measured by the Investigating Choice Experiments for the Preferences of Older People CAPability measure for Older people (ICECAP-O). The ICECAP-O measures five capability attributes of quality of life: attachment, security, role, enjoyment, and control. All items are scored from 1 (no capability) to 4 (full capability), with higher scores indicating a higher overall quality of life for the informal caregiver.
Time frame: 12 months
QOL-AD
Quality of life of persons with dementia measured by the Quality of Life- Alzheimer's Disease scale (QOL-AD). The QOL-AD measures the quality of life for individuals with dementia on 13 separate items on a four-point Likert scale ranging from "poor" to "excellent" and was proxy-rated. Total scores range from 13 to 52 points, with higher total scores indicating a higher quality of life.
Time frame: 12 months
EDIZ
Experienced burden of informal caregivers measured by the EDIZ ("Ervaren Druk door Informele Zorg" / experienced burden of informal care). The EDIZ is a 9-item measurement for informal caregivers to assess self-perceived pressure from informal care. All items are scored on a five-point Likert scale ranging from 1 ("no!") to 5 ("yes!"), with higher scores indicating more perceived stress by the informal caregiver.
Time frame: 12 months
QDRS
Cognitive status of the person with dementia as estimated by the informal caregiver measured by a selection of the Quick Dementia Rating System (QDRS). The QDRS measures cognitive impairment for people with dementia and consists of six behavioral and four cognitive questions though, in this research, only the cognitive questions will be included proxy rated. These four items are scored on a scale from 0 to 3, with higher scores indicating more cognitive impairment.
Time frame: 12 months
EQ-5D-5L
Health-related quality of life of the informal caregiver (self-rated) and the person with dementia (proxy-rated) will be determined via the EQ-5D-5L assessment developed by EuroQol, which measures health-related quality of life on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a five-point Likert scale. The five responses provide a health profile indicated by a five-digit number, reflecting patient-reported categories across the dimensions. A higher score corresponds to more serious complaints, and thus a lower health-related quality of life for the informal caregiver.
Time frame: 12 months
RUD
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD). This assessment measures the care resource use by the informal caregiver (self-rated) and the person with dementia (proxy-rated). For the caregiver, these resources include informal caregiver time (personal and instrumental activities of daily living and supervision), visits to care professionals, hospitalization, and productivity loss for those with a paid job. For the person with dementia, it covers accommodation (intermediate form, dementia-specific residential or long-term institutional care), visits to care professionals, hospitalizations, and social care services. The questions on medication usage were not included in this study.
Time frame: 12 months
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