Computer Agents to Promote Walking in the Elderly

This study has been completed.
Sponsor:
Collaborators:
Northeastern University
Stanford University
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00959712
First received: August 14, 2009
Last updated: November 7, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Computer Agents to Promote Walking in Older Adults With Low Health Literacy

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959712

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

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00959712     History of Changes
Other Study ID Numbers: R01 AG028668
Study First Received: August 14, 2009
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 16, 2014