Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06455163

Eerder Erbij: A Person-Centered Support Program for People With Dementia and Their Caregivers to Encourage Early Help

Led by VU University of Amsterdam · Updated on 2024-08-15

102

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

V

VU University of Amsterdam

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an early support program called Eerder Erbij (EE) for people living with mild dementia and their informal caregivers who live at home and receive little or no formal care. The study aims to see if this intervention can increase caregiver confidence, reduce care costs, and improve quality of life, with a focus on preventing severe decline and delaying admission to residential care. This pragmatic, cluster randomized trial is led by VU University of Amsterdam and involves caregivers and people with early-stage dementia. The intervention consists of a 6-week person-centered program that includes education, information, and support groups led by healthcare professionals. Sessions are tailored to meet the specific needs and strengths of the person with dementia and their caregiver. Participants in the intervention group receive EE, while those in the control group continue with their usual care, which may vary by location but typically involves minimal formal support. Participants will complete questionnaires at home at the start of the study and again at 3, 6, and 12 months to assess caregiver self-efficacy, quality of life, caregiver burden, and care costs. The study monitors delivery of the intervention and gathers feedback from participants and professionals. The main outcome measured is caregiver self-efficacy at 12 months. Total participation lasts at least one year, allowing for thorough evaluation of EE's effects and cost-utility.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Informal caregivers who support a person with dementia without pay
  • Caregiver visits the person with dementia at least 3 times a week if living apart
  • Person with dementia lives at home and is cared for by the caregiver
  • Person with dementia has diagnosed dementia or severe cognitive impairments suggesting dementia
  • Person with dementia receives formal personal care related to dementia no more than once per week
Not Eligible

You will not qualify if you...

  • Major mental or physical illness in caregiver or person with dementia affecting participation
  • Participation in another intervention or similar support program
  • Dementia caused by HIV, acquired brain impairment, Down syndrome, Huntington's disease-related chorea, or alcohol abuse
  • Inability to give informed consent
  • Informal caregiver younger than 18 years old

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants in the intervention group attend a 6-week person-centred support program consisting of education, information, and support group sessions designed for people with early stage dementia and their informal caregivers. Participants in the control group continue with their usual care.

Weekly group sessions for 6 weeks

Follow-up

Duration - 12 months

Participants are followed for 12 months after the intervention to assess caregiver self-efficacy and other supportive care outcomes.

Periodic assessments during 12 months

Trial Site Locations

Total: 1 location

1

Klinische Neuropsychologie

Amsterdam, North Holland, Netherlands, 1081 BT

Actively Recruiting

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Research Team

S

Sanne Balvert, Msc.

M

Maarten Milders, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

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.

Sander L Osstyn, Ron Handels, Lizzy M M Boots...

https://pubmed.ncbi.nlm.nih.gov/37349828

Cost-effectiveness of integrated care in frail elderly using the ICECAP-O and EQ-5D: does choice of instrument matter?

Peter Makai, Willemijn Looman, Eddy Adang...

https://pubmed.ncbi.nlm.nih.gov/24760405