Volunteers Adding Life in Dementia: VALID (VALID)

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

Older adults with Alzheimer's 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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer's Disease
• Intervention / Treatment: Other: Volunteer visits

Detailed Description

The number of older adults with Alzheimer's 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, volunteer's experience, and LTC staff stress, 3.) Determine key components of the VALID program that served as facilitators and barriers to implementation.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L3N6
      • Queen's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• resident in LTC facility 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 acute risk (i.e. suicidal ideation)
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Individuals will receive usual care
Experimental: Volunteer visits; Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.	Other: Volunteer visits; Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)	Baseline, weeks 2,4,6,8 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Neuropsychiatric Inventory score	Baseline, weeks 4, 8, 12
Change in Cornell Depression in Dementia Rating Scale score	Baseline, weeks 4, 8, 12
Change in Dementia Quality of Life Scale (DEMQoL) score	Baseline, weeks 4, 8, 12
Change in Clinical Global Impression of Change (CGI-C)score	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified nursing care assessment scale (M-NACS)		Baseline, week 12
Short Form Health Survey	Assessment of volunteer quality of life	Baseline, week 12

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Alzheimer's Association

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: VALIDII; NIRG-12-236827 (Other Grant/Funding Number: Alzheimer's Association)