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Empowerment Intervention for Persons With Young Onset Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02937883
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

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.

Condition or disease Intervention/treatment Phase
Dementia Empowerment Other: Empowerment intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of an Empowerment Intervention for Community-dwelling Persons With Young Onset Dementia and Their Informal Caregivers
Actual Study Start Date : October 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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



Primary Outcome Measures :
  1. Changes in self-management abilities [ Time Frame: 5 months ]
    (Self-Management Ability Scale (SMAS))


Secondary Outcome Measures :
  1. Changes in quality of life [ Time Frame: 5 months ]
    (Quality of life - Alzheimer Disease scale (QOL-AD))

  2. Changes in neuropsychiatric symptoms Questionnaire [ Time Frame: 5 months ]
    (Neuropsychiatric Inventory (NPI-Q))

  3. Changes in disability [ Time Frame: 5 months ]
    (Interview for Deterioration in Daily living activities in Dementia (IDDD))

  4. Changes in apathy [ Time Frame: 5 months ]
    (abbreviated Apathy Evaluation Scale (AES-10))

  5. Caregiver measures:Competence ( [ Time Frame: 5 months ]
    Short Sense of Competence Questionnaire (SSCQ))

  6. Caregiver measures: Emotional distress [ Time Frame: 5 months ]
    (NPI-Q distress score)


Other Outcome Measures:
  1. Analysis of qualitative focus group interviews with participants, caregivers and health care professionals [ Time Frame: 5 months ]
    Qualitative evaluation of the intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937883


Locations
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Netherlands
Florence
Den Haag, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
Investigators
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Principal Investigator: Raymond T CM Koopmans, MD, PhD Radboudumc Nijmegen
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02937883    
Other Study ID Numbers: 733050607
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Radboud University Medical Center:
Daily Activities
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders