Volunteers Adding Life in Dementia (VALID)
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ClinicalTrials.gov Identifier: NCT01646723 |
Recruitment Status
:
Completed
First Posted
: July 20, 2012
Last Update Posted
: April 14, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dementia Alzheimer Disease Behavior | Behavioral: Volunteers Adding Life in Dementia (VALID) Program | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: VALID Intervention
Volunteers Adding Life in Dementia (VALID) Program
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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.
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- Change in Cohen-Mansfield Agitation Inventory (CMAI) score [ Time Frame: Baseline and 12 weeks ]
- Clinically significant reduction in agitation [ Time Frame: Baseline and 12 weeks ]30% reduction in CMAI score
- Remission of neuropsychiatric symptoms [ Time Frame: Baseline and 12 weeks ]CMAI score <40
- Change in Neuropsychiatric Inventory (NPI) score [ Time Frame: Baseline and 12 weeks ]
- Change in depression symptoms (Cornell Depression in Dementia Rating Scale) [ Time Frame: Baseline and 12 weeks ]
- Dementia Quality of Life (DemQoL) Scale [ Time Frame: Baseline and 12 weeks ]
- Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline and 12 weeks ]
- Use and dose of required medication [ Time Frame: Baseline and 12 weeks ]
- Short form health survey [ Time Frame: Baseline and 12 weeks ]Volunteer quality of life
- Change in Modified Nursing Care Assessment Scale score [ Time Frame: Baseline and 12 weeks ]Assessing nursing stress.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646723
Canada, Ontario | |
Extendicare Kingston | |
Kingston, Ontario, Canada, K7M6P4 |
Principal Investigator: | Dallas P Seitz, MD | Queen's University |
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 Key Record Dates |
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 |