Volunteers Adding Life in Dementia (VALID)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2015 by Queen's University

Sponsor:

Information provided by (Responsible Party):

Dallas Seitz, Queen's University

ClinicalTrials.gov Identifier:

NCT01646723

First received: July 18, 2012

Last updated: April 21, 2015

Last verified: April 2015

History of Changes

Purpose

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	Intervention
Dementia Alzheimer Disease Behavior	Behavioral: Volunteers Adding Life in Dementia (VALID) Program


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Volunteers Adding Life in Dementia (VALID)

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

Change in Cohen-Mansfield Agitation Inventory (CMAI) score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinically significant reduction in agitation [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
30% reduction in CMAI score
Remission of neuropsychiatric symptoms [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
CMAI score <40
Change in Neuropsychiatric Inventory (NPI) score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Change in depression symptoms (Cornell Depression in Dementia Rating Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Dementia Quality of Life (DemQoL) Scale [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Use and dose of required medication [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Short form health survey [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Volunteer quality of life
Change in Modified Nursing Care Assessment Scale score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Assessing nursing stress.


Estimated Enrollment:	30
Study Start Date:	June 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646723

Contacts


Contact: Dallas P Seitz, MD	613-548-5567 ext 5942	dallas_seitz@hotmail.com

Locations


Canada, Ontario
Extendicare Kingston	Recruiting
Kingston, Ontario, Canada, K7M6P4
Contact: Luanne Halerewich 613-549-5010

Sponsors and Collaborators

Queen's University

Investigators


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

More Information


Responsible Party:	Dallas Seitz, MD, Queen's University
ClinicalTrials.gov Identifier:	NCT01646723 History of Changes
Other Study ID Numbers:	VALID1
Study First Received:	July 18, 2012
Last Updated:	April 21, 2015
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016

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