NCT02937883

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

August 1, 2016

Last Update Submit

August 30, 2018

Conditions

Keywords

Daily Activities

Outcome Measures

Primary Outcomes (1)

  • Changes in self-management abilities

    (Self-Management Ability Scale (SMAS))

    5 months

Secondary Outcomes (6)

  • Changes in quality of life

    5 months

  • Changes in neuropsychiatric symptoms Questionnaire

    5 months

  • Changes in disability

    5 months

  • Changes in apathy

    5 months

  • Caregiver measures:Competence (

    5 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Analysis of qualitative focus group interviews with participants, caregivers and health care professionals

    5 months

Study Arms (2)

empowerment intervention

EXPERIMENTAL

Empowerment intervention

Other: Empowerment intervention

regular care

NO INTERVENTION

Regular care, care as usual

Interventions

Empowerment intervention for persons with young onset dementia

empowerment intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with dementia before the age of 65
  • Living at home (community-dwelling)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florence

The Hague, Netherlands

Location

Related Publications (1)

  • Bielderman A, van Corven CTM, Koopmans RTCM, Leontjevas R, de Vugt ME, Bakker C, Gerritsen DL. Evaluation of the SPAN intervention for people living with young-onset dementia in the community and their family caregivers: a randomized controlled trial. Aging Ment Health. 2024 Jan-Feb;28(2):275-284. doi: 10.1080/13607863.2023.2260335. Epub 2024 Jan 31.

MeSH Terms

Conditions

DementiaEmpowerment

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Raymond T CM Koopmans, MD, PhD

    Radboudumc Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 4, 2018

Record last verified: 2018-08

Locations