CClinicalTrials.gg
CompletedNCT01715181VALIDUpdated Apr 14, 2017

Volunteers Adding Life in Dementia: VALID

An interventional study of Volunteer visits in Dementia and Alzheimer's Disease, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-04-14.

Sponsored by Queen's University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Dementia
  • Alzheimer's Disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • 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

Interventions

  • OtherVolunteer visits

    Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.

06

What researchers measure

Primary outcomes

  1. Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)

    Time frame: Baseline, weeks 2,4,6,8 and 12

Secondary outcomes

  1. Change in Neuropsychiatric Inventory score

    Time frame: Baseline, weeks 4, 8, 12

  2. Change in Cornell Depression in Dementia Rating Scale score

    Time frame: Baseline, weeks 4, 8, 12

  3. Change in Dementia Quality of Life Scale (DEMQoL) score

    Time frame: Baseline, weeks 4, 8, 12

  4. Change in Clinical Global Impression of Change (CGI-C)score

    Time frame: 12 weeks

Other outcomes

  1. Modified nursing care assessment scale (M-NACS)

    Time frame: Baseline, week 12

  2. Short Form Health Survey

    Assessment of volunteer quality of life

    Time frame: Baseline, week 12

07

Study locations

1 site
  • Queen's University
    Kingston, Ontario K7L3N6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01715181
Lead sponsor
Queen's University
Collaborators
Alzheimer's Association
Responsible party
Dr. Dallas Seitz (Assistant Professor, Queen's University) — Principal investigator
First posted
Oct 26, 2012
Start date
Jan 2013
Primary completion
Jun 2015
Completion
Mar 2016
Last update
Apr 14, 2017

Study contacts

Dallas P Seitz, MD
principal investigator · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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