Computer Agents to Promote Walking in the Elderly
1 other identifier
interventional
263
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 29, 2023
November 1, 2011
2.9 years
August 14, 2009
June 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Increase in physical activity (measured as step counts from pedometer)
1 year
Study Arms (2)
Control
NO INTERVENTIONSubjects are given a pedometer and step count log in which to record their daily step counts for 1 year.
ECA Interaction
ACTIVE COMPARATORSubjects 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.
Interventions
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 Criteria
You may qualify if:
- years old or greater
- English-speaking
- Actively being cared for by a primary care provider at Boston Medical Center
You may not qualify if:
- Non-ambulatory
- 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
- Medications that would compromise patient's ability to participate
- Had more than 2 falls in the past year (i.e. fall risk)
- Moderate to severe dementia
- Severe depression
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Northeastern Universitycollaborator
- Stanford Universitycollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca A Silliman, MD, PhD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
October 1, 2008
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 29, 2023
Record last verified: 2011-11