Volunteers Adding Life in Dementia (VALID)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dementia; Alzheimer Disease; Behavior	Behavioral: Volunteers Adding Life in Dementia (VALID) Program	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	75 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Volunteers Adding Life in Dementia (VALID)
Study Start Date :	June 2012
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	March 2016

Arms and Interventions

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Arm

Intervention/treatment

Experimental: VALID Intervention; Volunteers Adding Life in Dementia (VALID) Program

Behavioral: Volunteers 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.

Outcome Measures

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Primary Outcome Measures :

1. Change in Cohen-Mansfield Agitation Inventory (CMAI) score [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :

1. Clinically significant reduction in agitation [ Time Frame: Baseline and 12 weeks ]
   30% reduction in CMAI score
2. Remission of neuropsychiatric symptoms [ Time Frame: Baseline and 12 weeks ]
   CMAI score <40
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 [ Time Frame: Baseline and 12 weeks ]
   Volunteer quality of life
9. Change in Modified Nursing Care Assessment Scale score [ Time Frame: Baseline and 12 weeks ]
   Assessing nursing stress.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Ontario
Extendicare Kingston
Kingston, Ontario, Canada, K7M6P4

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:	Dallas P Seitz, MD	Queen's University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Dallas Seitz, MD, Queen's University
ClinicalTrials.gov Identifier:	NCT01646723 History of Changes
Other Study ID Numbers:	VALID1
First Posted:	July 20, 2012
Last Update Posted:	April 14, 2017
Last Verified:	April 2017

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases	Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders