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Volunteers Adding Life in Dementia (VALID)

Primary Purpose

Dementia, Alzheimer Disease, Behavior

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Volunteers Adding Life in Dementia (VALID) Program
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Extendicare Kingston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VALID Intervention

Arm Description

Volunteers Adding Life in Dementia (VALID) Program

Outcomes

Primary Outcome Measures

Change in Cohen-Mansfield Agitation Inventory (CMAI) score

Secondary Outcome Measures

Clinically significant reduction in agitation
30% reduction in CMAI score
Remission of neuropsychiatric symptoms
CMAI score <40
Change in Neuropsychiatric Inventory (NPI) score
Change in depression symptoms (Cornell Depression in Dementia Rating Scale)
Dementia Quality of Life (DemQoL) Scale
Clinical Global Impression of Change (CGI-C)
Use and dose of required medication
Short form health survey
Volunteer quality of life
Change in Modified Nursing Care Assessment Scale score
Assessing nursing stress.

Full Information

First Posted
July 18, 2012
Last Updated
April 13, 2017
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT01646723
Brief Title
Volunteers Adding Life in Dementia
Acronym
VALID
Official Title
Volunteers Adding Life in Dementia (VALID)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Behavior

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dallas P Seitz, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Extendicare Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7M6P4
Country
Canada

12. IPD Sharing Statement

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Volunteers Adding Life in Dementia

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