Empowerment Intervention for Persons With Young Onset Dementia

NCT ID: NCT02937883

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-30

Brief Summary

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The purpose of this study is to evaluate the effects of an empowerment intervention for community-dwelling persons with young onset dementia and their informal caregivers.

Detailed Description

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This study focuses on the evaluation of an empowerment intervention developed for persons with young onset dementia and their informal caregivers. The empowerment intervention focuses on current capacities, maintenance of autonomy, and increasing the opportunities to feel useful. This pragmatic cluster randomized controlled trial aims to investigate (1) the effectiveness of the intervention concerning participants' well-being, quality of life, and behavioral issues, (2) the effect of the intervention on the informal caregivers' sense of competence and perceived distress, and (3) the impact of the intervention on healthcare costs. Furthermore, the investigators aim to study the feasibility of the intervention to frame an implementation strategy.

Participants in the intervention group will receive the intervention for 5 months. Participants of the control group receive care as usual.

Conditions

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Dementia Empowerment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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empowerment intervention

Empowerment intervention

Group Type EXPERIMENTAL

Empowerment intervention

Intervention Type OTHER

Empowerment intervention for persons with young onset dementia

regular care

Regular care, care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Empowerment intervention

Empowerment intervention for persons with young onset dementia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with dementia before the age of 65
* Living at home (community-dwelling)

Exclusion Criteria

* Dementia is caused by Down's syndrome, Huntington's disease, HIV or alcohol-related dementia.
* Limited contact between the person with dementia and the informal caregiver (\<3 times a week)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond T CM Koopmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboudumc Nijmegen

Locations

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Florence

The Hague, , Netherlands

Site Status

Countries

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Netherlands

References

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Bielderman A, van Corven CTM, Koopmans RTCM, Leontjevas R, de Vugt ME, Bakker C, Gerritsen DL. Evaluation of the SPAN intervention for people living with young-onset dementia in the community and their family caregivers: a randomized controlled trial. Aging Ment Health. 2024 Jan-Feb;28(2):275-284. doi: 10.1080/13607863.2023.2260335. Epub 2024 Jan 31.

Reference Type DERIVED
PMID: 37776001 (View on PubMed)

Other Identifiers

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733050607

Identifier Type: -

Identifier Source: org_study_id

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