Computer Agents to Promote Walking in the Elderly

Aging Clinical Trial

Official title:

Computer Agents to Promote Walking in Older Adults With Low Health Literacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959712
• Other study ID #: R01AG028668
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	Northeastern University, Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in physical activity (measured as step counts from pedometer)		1 year