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Volunteers Adding Life in Dementia

Volunteers Adding Life in Dementia (VALID)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01646723
Acronym
VALID
Enrollment
75
Registered
2012-07-20
Start date
2012-06-30
Completion date
2016-03-31
Last updated
2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Behavior, Dementia

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.

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.

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frame
Change in Cohen-Mansfield Agitation Inventory (CMAI) scoreBaseline and 12 weeks

Secondary

MeasureTime frameDescription
Remission of neuropsychiatric symptomsBaseline and 12 weeksCMAI score \<40
Change in Neuropsychiatric Inventory (NPI) scoreBaseline and 12 weeks
Change in depression symptoms (Cornell Depression in Dementia Rating Scale)Baseline and 12 weeks
Dementia Quality of Life (DemQoL) ScaleBaseline and 12 weeks
Clinically significant reduction in agitationBaseline and 12 weeks30% reduction in CMAI score
Use and dose of required medicationBaseline and 12 weeks
Short form health surveyBaseline and 12 weeksVolunteer quality of life
Change in Modified Nursing Care Assessment Scale scoreBaseline and 12 weeksAssessing nursing stress.
Clinical Global Impression of Change (CGI-C)Baseline and 12 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026