Volunteers Adding Life in Dementia

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia; Behavior
• Interventions: Behavioral: Volunteers Adding Life in Dementia (VALID) Program

• Registration Number: NCT01646723
• Lead Sponsor: Queen's University

Brief Summary

The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• diagnosis of Alzheimer's disease or related forms of dementia
• significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of >39
• in nursing home for at least 30 days
• presence of a caregiver or substitute decision maker willing to consent to treatment
• no changes in psychotropic medications in the 2 weeks preceding enrolment in study

Exclusion Criteria

• depressive symptoms presenting risk
• physically aggressive behavior posing safety risk to others
• uncontrolled pain
• currently receiving palliative care
• medically unstable with life expectancy of < 6 months
• currently awaiting transfer to another LTC facility or hospital.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VALID Intervention	Volunteers Adding Life in Dementia (VALID) Program	Volunteers Adding Life in Dementia (VALID) Program

Primary Outcome Measures

Name	Time	Method
Change in Cohen-Mansfield Agitation Inventory (CMAI) score	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Clinically significant reduction in agitation	Baseline and 12 weeks	30% reduction in CMAI score
Change in depression symptoms (Cornell Depression in Dementia Rating Scale)	Baseline and 12 weeks
Change in Modified Nursing Care Assessment Scale score	Baseline and 12 weeks	Assessing nursing stress.
Clinical Global Impression of Change (CGI-C)	Baseline and 12 weeks
Remission of neuropsychiatric symptoms	Baseline and 12 weeks	CMAI score \<40
Change in Neuropsychiatric Inventory (NPI) score	Baseline and 12 weeks
Use and dose of required medication	Baseline and 12 weeks
Dementia Quality of Life (DemQoL) Scale	Baseline and 12 weeks
Short form health survey	Baseline and 12 weeks	Volunteer quality of life

Trial Locations

Locations (1)

Extendicare Kingston; 🇨🇦 Kingston, Ontario, Canada