Viewing Study NCT01715181



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Last Modification Date: 2024-10-26 @ 10:58 AM
Study NCT ID: NCT01715181
Status: COMPLETED
Last Update Posted: 2017-04-14
First Post: 2012-10-24

Brief Title: Volunteers Adding Life in Dementia VALID
Sponsor: Queens University
Organization: Queens University

Study Overview

Official Title: A Cluster-Randomized Controlled Trial Evaluating the Effects of a Volunteer-Led Nonpharmacological Intervention to Reduce Neuropsychiatric Symptoms of Dementia in Long-Term Care Residents
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: VALID
Brief Summary: Older adults with Alzheimers disease and other forms of dementia frequently develop challenging neuropsychiatric symptoms NPS as a result of their illness Non-pharmacological strategies to manage these symptoms such as music exercise and participating in pleasant social events have been demonstrated to be safe and effective strategies to reduce these behavioral symptoms Our project Volunteers Adding Life in Dementia VALID will design and implement a volunteer-led program to reduce behavioral symptoms and improve the quality of life of older adults with dementia who are residing in long-term care facilities
Detailed Description: The number of older adults with Alzheimers disease AD and related forms of dementia is increasing in Canada and the majority of individuals with dementia develop neuropsychiatric symptoms NPS such as agitation psychosis depression and anxiety at some time during their illness NPS are particularly problematic in long-term care LTC where approximately 60 of individuals have dementia and 80 of individuals with dementia have NPS at any time Adverse outcomes associated with NPS include increased use of psychotropic medications stress for families and nursing staff increased costs of care and decreased quality of life A novel approach to implementing non-pharmacological interventions for LTC residents with NPS is the use of volunteers Volunteer-led programs have been demonstrated to be an effective inexpensive and sustainable method of implementing psychosocial interventions for older adults in acute care The objectives of our project are to 1 Recruit and train approximately 40 volunteers in the VALID program 2 Conduct a cluster-randomized controlled trial of the VALID program in 6 LTC facilities 3 intervention and 3 control LTC sites 60 individuals with dementia in each of the experimental and control arms to determine the effect of the VALID program on symptoms of NPS patient quality of life volunteers experience and LTC staff stress 3 Determine key components of the VALID program that served as facilitators and barriers to implementation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NIRG-12-236827 OTHER_GRANT Alzheimers Association None