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Empowerment Intervention for Persons With Young Onset Dementia

Primary Purpose

Dementia, Empowerment

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Empowerment intervention
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Daily Activities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Florence

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

empowerment intervention

regular care

Arm Description

Empowerment intervention

Regular care, care as usual

Outcomes

Primary Outcome Measures

Changes in self-management abilities
(Self-Management Ability Scale (SMAS))

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2016
Last Updated
August 30, 2018
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02937883
Brief Title
Empowerment Intervention for Persons With Young Onset Dementia
Official Title
Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Empowerment
Keywords
Daily Activities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
empowerment intervention
Arm Type
Experimental
Arm Description
Empowerment intervention
Arm Title
regular care
Arm Type
No Intervention
Arm Description
Regular care, care as usual
Intervention Type
Other
Intervention Name(s)
Empowerment intervention
Intervention Description
Empowerment intervention for persons with young onset dementia
Primary Outcome Measure Information:
Title
Changes in self-management abilities
Description
(Self-Management Ability Scale (SMAS))
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Changes in quality of life
Description
(Quality of life - Alzheimer Disease scale (QOL-AD))
Time Frame
5 months
Title
Changes in neuropsychiatric symptoms Questionnaire
Description
(Neuropsychiatric Inventory (NPI-Q))
Time Frame
5 months
Title
Changes in disability
Description
(Interview for Deterioration in Daily living activities in Dementia (IDDD))
Time Frame
5 months
Title
Changes in apathy
Description
(abbreviated Apathy Evaluation Scale (AES-10))
Time Frame
5 months
Title
Caregiver measures:Competence (
Description
Short Sense of Competence Questionnaire (SSCQ))
Time Frame
5 months
Title
Caregiver measures: Emotional distress
Description
(NPI-Q distress score)
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Analysis of qualitative focus group interviews with participants, caregivers and health care professionals
Description
Qualitative evaluation of the intervention
Time Frame
5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T CM Koopmans, MD, PhD
Organizational Affiliation
Radboudumc Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florence
City
Den Haag
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Empowerment Intervention for Persons With Young Onset Dementia

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