Computer Agents to Promote Walking in the Elderly

NCT ID: NCT00959712

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-09-30

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

Subjects are given a pedometer and step count log in which to record their daily step counts for 1 year.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

ECA Interaction

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca A Silliman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Other Identifiers

R01AG028668

Identifier Type: NIH

Identifier Source: org_study_id

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