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Computer Agents to Promote Walking in the Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959712
First Posted: August 17, 2009
Last Update Posted: November 8, 2011
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.
Collaborators:
Northeastern University
Stanford University
Information provided by (Responsible Party):
Boston Medical Center
  Purpose
This proposal is a randomized control trial using innovative interactive health technologies to promote and sustain walking behavior among elderly patients. The technology uses an Embodied Conversational Agent (ECA), a computer character that simulates face-to-face conversation. The trial will be block randomized by literacy status and include an intensive two-month, daily contact intervention via a Tablet PC ECA in the subject's home, an automated telephone program, and then an in-clinic, kiosk-based ECA for an additional 10 months, to promote maintenance of walking behavior. The study will occur in 2 phases, a pilot phase in which 20 subjects will be enrolled for the purpose of pre- testing the intervention and all data collection instruments, and a main study phase in which an additional 264 subjects will be enrolled.

Condition Intervention
Aging Behavioral: ECA Interaction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Computer Agents to Promote Walking in Older Adults With Low Health Literacy

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Increase in physical activity (measured as step counts from pedometer) [ Time Frame: 1 year ]

Enrollment: 263
Study Start Date: October 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Subjects are given a pedometer and step count log in which to record their daily step counts for 1 year.
Active Comparator: ECA Interaction
Subjects are given pedometers and step count logs in which to record their daily steps for 1 year. Subjects are also given a tablet computer and instructed to interact with the ECA (Embodied Conversational Agent) "Tanya" every day for 2 months.
Behavioral: ECA Interaction
The technology uses a computer character (Embodied Conversational Agent (ECA)) that simulates face-to-face conversation. The ECA talks to the patient and the patient responds by tapping a touch-screen.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 65 years old or greater
  2. English-speaking
  3. Actively being cared for by a primary care provider at Boston Medical Center

Exclusion Criteria:

  1. Non-ambulatory
  2. Any medical condition or disorder that would limit participation in moderate intensity physical activity (such as sustained walking), including life-threatening disorders, myocardial ischemia, complex cardiac arrhythmias or significant left ventricular dysfunction, and major functional disabilities relating to gait or balance
  3. Medications that would compromise patient's ability to participate
  4. Had more than 2 falls in the past year (i.e. fall risk)
  5. Moderate to severe dementia
  6. Severe depression
  7. Currently exercising, i.e., engaged regularly in moderate-intensity or more vigorous physical activity 3 or more days per week for at least 20 minutes per day
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959712


Sponsors and Collaborators
Boston Medical Center
Northeastern University
Stanford University
Investigators
Principal Investigator: Rebecca A Silliman, MD, PhD Boston University
  More Information

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00959712     History of Changes
Other Study ID Numbers: R01AG028668 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2009
First Posted: August 17, 2009
Last Update Posted: November 8, 2011
Last Verified: November 2011