NCT02965651

Brief Summary

The purpose of this randomized controlled trial is to evaluate the feasibility of introducing an innovative eHealth technology, the Embodied Conversational Agent (ECA), to diverse women from an urban outpatient setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

November 7, 2016

Last Update Submit

March 15, 2017

Conditions

Stress, Emotional

Keywords

embodied conversational agentvirtual patient agentmeditationmindfulness based stress reductionnutrition

Outcome Measures

Primary Outcomes (5)

  • Number of people recruited

    1 year

  • Number of participants who completed the study

    1 month

  • Number of participants whom outcome data can be collected

    1 month

  • Number of participants who were racial minorities (non-white)

    1 month

  • Participant satisfaction with either treatment arm

    Likert scale of 1-7 (1=not satisfied, 7=very satisfied)

    1 month

Secondary Outcomes (19)

  • Age

    1 month

  • Race

    1 month

  • Ethnicity

    1 month

  • Education Level

    1 month

  • Work Status

    1 month

  • +14 more secondary outcomes

Study Arms (2)

ECA System

EXPERIMENTAL

Access to website and virtual patient advocate

Behavioral: ECA System

Standard of Care

NO INTERVENTION

Patient information sheets and meditation CD

Interventions

ECA SystemBEHAVIORAL

The ECA system, named "Gabby", included content pertaining to stress management, nutrition and physical activity as well as dialogue scripts and media such as meditations. The scripts included motivational interviewing dialogue: dialogue to simulate shared decision making interactions and additional longitudinal interaction using techniques such as "goal setting," "problem solving," "tips," and "homework". Gabby was available on a web browser through a username and secure password login.

ECA System

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English fluency sufficient to follow treatment instructions and answer survey questions
  • Access to a telephone (landline, cellular phone)
  • Access to a computer/laptop with internet/Wi-Fi access

You may not qualify if:

  • Known or planned pregnancy
  • Mental health or substance abuse problems that would bar completion of study
  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Gardiner P, Hempstead MB, Ring L, Bickmore T, Yinusa-Nyahkoon L, Tran H, Paasche-Orlow M, Damus K, Jack B. Reaching women through health information technology: the Gabby preconception care system. Am J Health Promot. 2013 Jan-Feb;27(3 Suppl):eS11-20. doi: 10.4278/ajhp.1200113-QUAN-18.

    PMID: 23286652RESULT

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Paula Gardiner, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 17, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)