Volunteers Adding Life in Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Volunteers Adding Life in Dementia (VALID)

Conditions
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Dementia, Alzheimer Disease, Behavior

Intervention / Treatment
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* Behavioral: Volunteers Adding Life in Dementia (VALID) Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VALID Intervention<br>Volunteers Adding Life in Dementia (VALID) Program | Behavioral: Volunteers Adding Life in Dementia (VALID) Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cohen-Mansfield Agitation Inventory (CMAI) score |  | Baseline and 12 weeks | 

Secondary Outcome Measures

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