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A Randomized Controlled Trial of Using Video Images in Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00704886
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : June 23, 2009
Sponsor:
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by:
Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE June 23, 2008
First Posted Date  ICMJE June 25, 2008
Last Update Posted Date June 23, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2008)
preferences [ Time Frame: at time of interview ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Using Video Images in Dementia
Official Title  ICMJE A Randomized Controlled Trial of Using Video Images in Dementia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE Other: video
video of dementia
Other Name: video decision aid
Study Arms  ICMJE
  • No Intervention: 1
    verbal
  • Experimental: 2
    video
    Intervention: Other: video
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2008)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Over 64

Exclusion Criteria:

  • Can't speak English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00704886
Other Study ID Numbers  ICMJE 2007p001264
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angelo Volandes, MD PI, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Foundation for Informed Medical Decision Making
Investigators  ICMJE
Principal Investigator: Angelo Volandes, MD MGH
PRS Account Massachusetts General Hospital
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP