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

Dementia, Mild Clinical Trial

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

Status Recruiting

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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild

• NCT number: NCT06455163
• Study type: Interventional
• Source: VU University of Amsterdam
• Contact: Sanne Balvert, Msc.
• Phone: 020 59 83 293
• Email: s.c.e.balvert@vu.nl
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Completion date: May 31, 2026