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Volunteers Adding Life in Dementia (VALID)

This study is currently recruiting participants.
Verified July 2012 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: July 20, 2012
Last verified: July 2012
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:

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: December 2012
Estimated Primary Completion Date: November 2012 (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.

  Eligibility

Ages Eligible for Study:   65 Years and older
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
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

No publications provided

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: July 20, 2012
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013