Volunteers Adding Life in Dementia (VALID)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified October 2014 by Queen's University
Sponsor:
Queen's University
Information provided by (Responsible Party):
Dallas Seitz, Queen's University
ClinicalTrials.gov Identifier:
NCT01646723
First received: July 18, 2012
Last updated: October 23, 2014
Last verified: October 2014
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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:
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 2015 |
| Estimated Primary Completion Date: | December 2014 (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
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
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: | October 23, 2014 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies |
ClinicalTrials.gov processed this record on February 26, 2015