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
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Daily Activities
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)
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
NCT ID
NCT02937883
First Posted
August 1, 2016
Last Updated
August 30, 2018
Sponsor
Radboud University Medical Center
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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