NCT00959712

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Status
completed

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

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 29, 2023

Status Verified

November 1, 2011

Enrollment Period

2.9 years

First QC Date

August 14, 2009

Last Update Submit

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 INTERVENTION

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

ECA Interaction

ACTIVE COMPARATOR

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

Interventions

ECA InteractionBEHAVIORAL

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.

ECA Interaction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Study Officials

  • Rebecca A Silliman, MD, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

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