A Randomized Controlled Trial of Using Video Images in Dementia

June 22, 2009 updated by: Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outcome measures were what subjects wanted if they had advanced dementia.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 64

Exclusion Criteria:

  • Can't speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
verbal
Experimental: 2
video
Other: video
video of dementia
Other Names:
  • video decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
preferences
Time Frame: at time of interview
at time of interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Foundation for Informed Medical Decision Making

Investigators

  • Principal Investigator: Angelo Volandes, MD, MGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2009

Last Update Submitted That Met QC Criteria

June 22, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007p001264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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