- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00959712
Computer Agents to Promote Walking in the Elderly
June 27, 2023 updated by: Boston Medical Center
Computer Agents to Promote Walking in Older Adults With Low Health Literacy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
263
Phase
- Not Applicable
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
No
Description
Inclusion Criteria:
- 65 years old or greater
- English-speaking
- Actively being cared for by a primary care provider at Boston Medical Center
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in physical activity (measured as step counts from pedometer)
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca A Silliman, MD, PhD, Boston University
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
October 1, 2008
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 14, 2009
First Posted (Estimated)
August 17, 2009
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
November 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- R01AG028668 (U.S. NIH Grant/Contract)
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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