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

NCT06455163 | Recruiting DMC

• 1 other identifier: 852002106
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dementia, Mild

Keywords

Early-stage dementia; Informal caregiver; Informal care

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (8)

• TOPICS-MDS

  12 months

• HADS

  12 months

• ICECAP-O

  12 months

• QOL-AD

  12 months

• EDIZ

  12 months

Study Arms (2)

Eerder Erbij (intervention group)

EXPERIMENTAL

Informal caregivers and people with dementia assigned to the intervention group will receive the 6-week intervention "Eerder Erbij".

Other: Eerder Erbij

Usual/standard care (control group)

NO INTERVENTION

Participants in the comparison condition will continue to receive usual care. Care for people with dementia in the Netherlands varies across municipalities, but the majority lives at home and especially earlier stages of the disease, most people living with dementia and their informal caregivers use no or very little formal care, apart from occasional visitors to GP or by case manager. The control group will be shared with another collaborating study from 'Maastricht University', which has the same goals, applies the same inclusion criteria, applies the same study procedures, and obtains the same outcomes. This implies that the data of the participants recruited for the control group for this study will be shared with the collaborating study.

Interventions

Eerder Erbij OTHER

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.

Eerder Erbij (intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).

You may not qualify if:

• 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.
• Informal caregiver is younger than 18 years old.

Sponsors & Collaborators

• VU University of Amsterdam: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Maastricht University: collaborator

Study Sites (1)

Klinische Neuropsychologie

Amsterdam, North Holland, 1081 BT, Netherlands

RECRUITING

Related Publications (7)

• 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.

  PMID: 37349828 BACKGROUND

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 BACKGROUND

• Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.

  PMID: 12028884 BACKGROUND

• Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.

  PMID: 12021425 BACKGROUND

• Makai P, Looman W, Adang E, Melis R, Stolk E, Fabbricotti I. Cost-effectiveness of integrated care in frail elderly using the ICECAP-O and EQ-5D: does choice of instrument matter? Eur J Health Econ. 2015 May;16(4):437-50. doi: 10.1007/s10198-014-0583-7. Epub 2014 Apr 24.

  PMID: 24760405 BACKGROUND

• Wimo A, Gustavsson A, Jonsson L, Winblad B, Hsu MA, Gannon B. Application of Resource Utilization in Dementia (RUD) instrument in a global setting. Alzheimers Dement. 2013 Jul;9(4):429-435.e17. doi: 10.1016/j.jalz.2012.06.008. Epub 2012 Nov 9.

  PMID: 23142433 BACKGROUND

• Pot AM, van Dyck R, Deeg DJ. [Perceived stress caused by informal caregiving. Construction of a scale]. Tijdschr Gerontol Geriatr. 1995 Oct;26(5):214-9. Dutch.

  PMID: 8750982 BACKGROUND

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Sanne Balvert, Msc.

CONTACT

s.c.e.balvert@vu.nl

Maarten Milders, Dr.

CONTACT

m.v.milders@vu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2021
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)