Volunteers Adding Life in Dementia (VALID)

Volunteers Adding Life in Dementia (VALID)

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Behavior
• Intervention / Treatment: Behavioral: Volunteers Adding Life in Dementia (VALID) Program

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (ESTIMATE): July 20, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: VALID1