NCT02947477

Brief Summary

The proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2017

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

October 24, 2016

Last Update Submit

January 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Retention of Participants Iphone App for Residents

    Quantify amount of drop out through out the 14 day study and how many reports are responded two daily

    14 days

  • Acceptability of Iphone App for Residents Online Evaluation and Mini Interviews

    Evaluate online questions and qualitative mini interviews about the usability of the app

    30 days

Secondary Outcomes (3)

  • Real Time Assessment Comparison to Standardized Measures

    35 days

  • Ecological Assessment of Emotions Compared to Standardized Emotion Awareness Measures, PANAS

    14 days

  • Ecological Assessment of Stress Compared to Standardized Perceived Stress and Emotional Exhaustion from the Maslach Burnout Inventory

    14 days

Other Outcomes (3)

  • Exploratory Analysis of Reduction in Pre and Post Reported Emotional Exhaustion on the MBI

    30 days

  • Exploratory Analysis of Reduction in Pre and Post Reported Stress on PSS and MBI

    30 days

  • Exploratory Analysis of Increase in Pre and Post Reported Resilience on the CDRisc

    30 days

Study Arms (2)

Treatment

EXPERIMENTAL

The EMA intervention uses twice-a-day interactive questions for emotion tracking including type of emotion, intensity of emotion, trigger to emotion and response to emotion through an Iphone app designed for the study. The study users receive individualized feedback about their daily reporting of emotions, sleep and stress.The study tracking is for 14 days.

Behavioral: EmoTrak

Control

NO INTERVENTION

The control arm does nothing for 14 days and then receives the 14 day emotion tracking listed above.

Interventions

EmoTrakBEHAVIORAL

Ecological Momentary Assessment of Emotion through Iphone App

Treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently in Residency or Fellowship at UCSF

You may not qualify if:

  • Not having an Iphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94114, United States

Location

Related Publications (1)

  • Riess H, Kelley JM, Bailey RW, Dunn EJ, Phillips M. Empathy training for resident physicians: a randomized controlled trial of a neuroscience-informed curriculum. J Gen Intern Med. 2012 Oct;27(10):1280-6. doi: 10.1007/s11606-012-2063-z. Epub 2012 May 2.

    PMID: 22549298BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Eve Ekman, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

December 17, 2017

Study Completion

December 17, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations