CClinicalTrials.gg
CompletedNCT01646723VALIDUpdated Apr 14, 2017

Volunteers Adding Life in Dementia

An interventional study of Volunteers Adding Life in Dementia (VALID) Program in Dementia, Alzheimer Disease and Behavior, 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
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia
  • Alzheimer Disease
  • Behavior
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
  • 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

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.
05

Study design

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

Study arms

  • Experimental
    VALID Intervention

    Volunteers Adding Life in Dementia (VALID) Program

    Behavioral: Volunteers Adding Life in Dementia (VALID) Program

Interventions

  • BehavioralVolunteers Adding Life in Dementia (VALID) Program

    The VALID intervention will consist of 2 phases. First, volunteers will complete an assessment involving recording of a "Life Story" for each patient participant. This will include information on the patient's psychosocial history, occupational history, hobbies, interests and preferred activities using information from the LTC medical record and interviews with the patient and family members. Based on this information, a variety of potential psychosocial interventions will be developed for the individual with the assistance of the recreation therapist at the LTC. The second phase will involve implementation of the VALID intervention. Each individual with dementia will receive personalized pleasant activities for a minimum session of 30 minutes at a frequency of 3 times per week. One volunteer will complete the "Life Story" assessment and up to 3 volunteers may be involved with implementing the VALID program for each resident.

06

What researchers measure

Primary outcomes

  1. Change in Cohen-Mansfield Agitation Inventory (CMAI) score

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Clinically significant reduction in agitation

    30% reduction in CMAI score

    Time frame: Baseline and 12 weeks

  2. Remission of neuropsychiatric symptoms

    CMAI score \<40

    Time frame: Baseline and 12 weeks

  3. Change in Neuropsychiatric Inventory (NPI) score

    Time frame: Baseline and 12 weeks

  4. Change in depression symptoms (Cornell Depression in Dementia Rating Scale)

    Time frame: Baseline and 12 weeks

  5. Dementia Quality of Life (DemQoL) Scale

    Time frame: Baseline and 12 weeks

  6. Clinical Global Impression of Change (CGI-C)

    Time frame: Baseline and 12 weeks

  7. Use and dose of required medication

    Time frame: Baseline and 12 weeks

  8. Short form health survey

    Volunteer quality of life

    Time frame: Baseline and 12 weeks

  9. Change in Modified Nursing Care Assessment Scale score

    Assessing nursing stress.

    Time frame: Baseline and 12 weeks

07

Study locations

1 site
  • Extendicare Kingston
    Kingston, Ontario K7M6P4, 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
NCT01646723
Lead sponsor
Queen's University
Responsible party
Dr. Dallas Seitz (MD, Queen's University) — Principal investigator
First posted
Jul 20, 2012
Start date
Jun 2012
Primary completion
Dec 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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