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).
Informal caregivers can be spouses, relatives, or friends who care for and support the person with dementia without pay. If the caregiver does not live with the person with dementia, they have to visit the person with dementia at least 3 times a week to be eligible for the study.
The person with dementia must be living at home cared for by the caregiver.
The person with dementia should have a diagnosis of dementia or experience severe cognitive impairments suggesting dementia. Type of dementia is not an inclusion criterion.
The person with dementia is not yet receiving formal care related to personal activities of daily living on account of his or her dementia more than once a week (defined by receiving assistance from a paid worker by e.g., health or social care professional as help with dressing/undressing; washing/bathing/showering; toileting; feeding/drinking; or taking medication).
Main exclusion criteria for both the caregiver and the person with dementia will be major mental or physical illness, such as major depression or stroke, that would affect their ability to participate in this study.
Person with dementia or informal caregiver is participating in another intervention or similar support program.
Dementia is caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea associated with Huntington's disease, or alcohol abuse.
Inability to give informed consent will also be an exclusion criterion.
Parallel
Eerder Erbij
Other interventionThe 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.
Caregiver 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.
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).
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.
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.
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.
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VU University of Amsterdam
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Maastricht University
Collaborator
