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

August 13, 2024 updated by: Sanne Balvert, VU University of Amsterdam

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 BT
        • Recruiting
        • Klinische Neuropsychologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eerder Erbij (intervention group)
Informal caregivers and people with dementia assigned to the intervention group will receive the 6-week intervention "Eerder Erbij".
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.
No Intervention: Usual/standard care (control group)

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caregiver Self-efficacy Scale (CSES)
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TOPICS-MDS
Time Frame: 12 months

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
HADS
Time Frame: 12 months
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.
12 months
ICECAP-O
Time Frame: 12 months
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.
12 months
QOL-AD
Time Frame: 12 months
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.
12 months
EDIZ
Time Frame: 12 months
Experienced burden of informal caregivers measured by the EDIZ ("Ervaren Druk door Informele Zorg" / experienced burden of informal care). The EDIZ is a 9-item measurement for informal caregivers to assess self-perceived pressure from informal care. All items are scored on a five-point Likert scale ranging from 1 ("no!") to 5 ("yes!"), with higher scores indicating more perceived stress by the informal caregiver.
12 months
QDRS
Time Frame: 12 months
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 QDRS measures cognitive impairment for people with dementia and consists of six behavioral and four cognitive questions though, in this research, only the cognitive questions will be included proxy rated. These four items are scored on a scale from 0 to 3, with higher scores indicating more cognitive impairment.
12 months
EQ-5D-5L
Time Frame: 12 months
Health-related quality of life of the informal caregiver (self-rated) and the person with dementia (proxy-rated) will be determined via the EQ-5D-5L assessment developed by EuroQol, which measures health-related quality of life on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a five-point Likert scale. The five responses provide a health profile indicated by a five-digit number, reflecting patient-reported categories across the dimensions. A higher score corresponds to more serious complaints, and thus a lower health-related quality of life for the informal caregiver.
12 months
RUD
Time Frame: 12 months
Healthcare resource use of the informal caregivers and persons with dementia measured by the Resource Utilization in Dementia (RUD). This assessment measures the care resource use by the informal caregiver (self-rated) and the person with dementia (proxy-rated). For the caregiver, these resources include informal caregiver time (personal and instrumental activities of daily living and supervision), visits to care professionals, hospitalization, and productivity loss for those with a paid job. For the person with dementia, it covers accommodation (intermediate form, dementia-specific residential or long-term institutional care), visits to care professionals, hospitalizations, and social care services. The questions on medication usage were not included in this study.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VU University of Amsterdam

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University
ZonMw: The Netherlands Organisation for Health Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 852002106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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