Empowerment Intervention for Persons With Young Onset Dementia

August 30, 2018 updated by: Radboud University Medical Center

Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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
Intervention / Treatment
Experimental: empowerment intervention
Empowerment intervention
Other: Empowerment intervention
Empowerment intervention for persons with young onset dementia
No Intervention: regular care
Regular care, care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in self-management abilities
Time Frame: 5 months
(Self-Management Ability Scale (SMAS))
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life
Time Frame: 5 months
(Quality of life - Alzheimer Disease scale (QOL-AD))
5 months
Changes in neuropsychiatric symptoms Questionnaire
Time Frame: 5 months
(Neuropsychiatric Inventory (NPI-Q))
5 months
Changes in disability
Time Frame: 5 months
(Interview for Deterioration in Daily living activities in Dementia (IDDD))
5 months
Changes in apathy
Time Frame: 5 months
(abbreviated Apathy Evaluation Scale (AES-10))
5 months
Caregiver measures:Competence (
Time Frame: 5 months
Short Sense of Competence Questionnaire (SSCQ))
5 months
Caregiver measures: Emotional distress
Time Frame: 5 months
(NPI-Q distress score)
5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of qualitative focus group interviews with participants, caregivers and health care professionals
Time Frame: 5 months
Qualitative evaluation of the intervention
5 months

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Raymond T CM Koopmans, MD, PhD, Radboudumc Nijmegen

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)

October 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 4, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 733050607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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