Empowerment Intervention for Persons With Young Onset Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937883
• Other study ID #: 733050607
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Dementia
• Empowerment

Intervention

Other:
• Empowerment intervention
Empowerment intervention for persons with young onset dementia

Locations

Country	Name	City	State
Netherlands	Florence	Den Haag

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analysis of qualitative focus group interviews with participants, caregivers and health care professionals	Qualitative evaluation of the intervention	5 months
Primary	Changes in self-management abilities	(Self-Management Ability Scale (SMAS))	5 months
Secondary	Changes in quality of life	(Quality of life - Alzheimer Disease scale (QOL-AD))	5 months
Secondary	Changes in neuropsychiatric symptoms Questionnaire	(Neuropsychiatric Inventory (NPI-Q))	5 months
Secondary	Changes in disability	(Interview for Deterioration in Daily living activities in Dementia (IDDD))	5 months
Secondary	Changes in apathy	(abbreviated Apathy Evaluation Scale (AES-10))	5 months
Secondary	Caregiver measures:Competence (	Short Sense of Competence Questionnaire (SSCQ))	5 months
Secondary	Caregiver measures: Emotional distress	(NPI-Q distress score)	5 months