A Randomized Controlled Trial of Using Video Images in Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring dementia
Eligibility Criteria
Inclusion Criteria:
- Over 64
Exclusion Criteria:
- Can't speak English
Sites / Locations
- MGH
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
verbal
video
Outcomes
Primary Outcome Measures
preferences
Secondary Outcome Measures
Full Information
NCT ID
NCT00704886
First Posted
June 23, 2008
Last Updated
June 22, 2009
Sponsor
Massachusetts General Hospital
Collaborators
Foundation for Informed Medical Decision Making
1. Study Identification
Unique Protocol Identification Number
NCT00704886
Brief Title
A Randomized Controlled Trial of Using Video Images in Dementia
Official Title
A Randomized Controlled Trial of Using Video Images in Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Foundation for Informed Medical Decision Making
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
BACKGROUND: Advance care planning (ACP) is the process in which patients plan for future medical care under circumstances of impaired decision-making. Video is an underutilized medium that can assist clinicians in discussions of future health states, such as the state of advanced dementia. Video may enable patients to visualize the future by concisely providing complex information vital for ACP. This study will examine whether the use of video could facilitate a more comprehensive understanding of advanced dementia and inform clinician-patient discussions about the level of care a patient would want in the event of advanced dementia.
RESEARCH PLAN: We propose to conduct a randomized trial studying ACP for 200 elderly subjects using a video depiction of a patient with dementia compared to the traditional verbal narrative. Specific aims 1 and 2 assess the effect of a video of advanced dementia on the clinical decision making of elderly subjects compared to the traditional verbal narrative.
Detailed Description
Outcome measures were what subjects wanted if they had advanced dementia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
verbal
Arm Title
2
Arm Type
Experimental
Arm Description
video
Intervention Type
Other
Intervention Name(s)
video
Other Intervention Name(s)
video decision aid
Intervention Description
video of dementia
Primary Outcome Measure Information:
Title
preferences
Time Frame
at time of interview
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Over 64
Exclusion Criteria:
Can't speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19477893
Citation
Volandes AE, Paasche-Orlow MK, Barry MJ, Gillick MR, Minaker KL, Chang Y, Cook EF, Abbo ED, El-Jawahri A, Mitchell SL. Video decision support tool for advance care planning in dementia: randomised controlled trial. BMJ. 2009 May 28;338:b2159. doi: 10.1136/bmj.b2159.
Results Reference
derived
Learn more about this trial
A Randomized Controlled Trial of Using Video Images in Dementia
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