Eerder Erbij: The Path Towards Offering Timely Support for People With Dementia and Their Caregivers

Dementia, Mild Clinical Trial

— EE  

Official title:

Eerder Erbij: Een Vroege Ondersteuning Voor Mensen Met Dementie en Hun Mantelzorgers. The Path Towards Offering Timely Support for People With Dementia and Their Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455163
• Other study ID #: 852002106
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: VU University of Amsterdam
• Contact: Sanne Balvert, Msc.
• Phone: 020 59 83 293
• Email: s.c.e.balvert[@]vu.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

• Informal caregiver is younger than 18 years old.

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild

Intervention

Other:
• Eerder Erbij
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.

Locations

Country	Name	City	State
Netherlands	Klinische Neuropsychologie	Amsterdam	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
VU University of Amsterdam	Maastricht University, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Osstyn SL, Handels R, Boots LMM, Balvert SCE, Evers SMAA, de Vugt ME. The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial. Trials. 2023 Jun 22;24(1):427. doi: 10.1186/s13063-023-07423-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Self-efficacy Scale (CSES)	The self-efficacy of informal caregivers measured by the Caregiver Self-efficacy Scale (CSES) (Fortinsky, 2002). The maximum and minimum answer scores range from 1 to 10 with higher scores indicating better outcomes.	12 months
Secondary	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)	12 months
Secondary	HADS	Depression and anxiety of informal caregivers measured by the Hospital and Anxiety Depression Scale (HADS) (Bjelland, 2002). The questionnaire is scored on a 4-point Likert scale.	12 months
Secondary	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) (Makai, 2015). The questionnaire is scored on a 4-point Likert scale.	12 months
Secondary	QOL-AD	Quality of life of persons with dementia measured by the Quality of Life- Alzheimer's Disease scale (QOL-AD) (Logsdon et al., 2002). The questionnaire is scored on a 4-point Likert scale.	12 months
Secondary	EDIZ	Experienced burden of informal caregivers measured by the EDIZ ("Ervaren Druk door Informele Zorg" / experienced burden of informal care) (Pot, 1995). The questionnaire is scored on a 5-point Likert scale.	12 months
Secondary	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 questionnaire is scored on a 5-point Likert scale.	12 months
Secondary	EQ-5D-5L	Health-related quality-of-life of the informal caregivers and persons with dementia measured by the EQ-5D-5L. The questionnaire is scored on a 5-point Likert scale.	12 months
Secondary	RUD	Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD) (Wimo, 2013).	12 months