NCT02097355

Brief Summary

TriVox Health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=VR1vcbx0Ef4). Using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of TriVox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD), asthma, autism, depression, and epilepsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
946

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

5 years

First QC Date

March 21, 2014

Last Update Submit

July 13, 2020

Conditions

Keywords

chronic diseasepatient portalhealth information technologypatient provider communicationquality improvement

Outcome Measures

Primary Outcomes (1)

  • Change in caregiver-rated disease-specific symptoms

    Caregiver-reported ratings on disease-specific symptom rating scale. For example, Vanderbilt ADHD Parent Rating Scale for ADHD; Asthma Control Test for asthma

    Baseline to 12 months

Secondary Outcomes (3)

  • Number of patients with "red flag" alerts

    1 month

  • Change in caregiver-rated global functioning

    Baseline to 12 months

  • Experience of care

    Baseline and after every ambulatory visit for up to 84 months

Other Outcomes (2)

  • Healthcare utilization

    12 months

  • Direct out of pocket expenditures

    12 months

Study Arms (2)

TriVox Active

EXPERIMENTAL

Provider using TriVox for clinical care

Other: TriVox for clinical care

TriVox Delayed-start

NO INTERVENTION

Providers not using TriVox for clinical care

Interventions

Use TriVox disease modules to manage patients

TriVox Active

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatric patients with clinical diagnosis of ADHD, asthma, autism, depression, and/or epilepsy
  • Patient receives care for these diagnoses from providers in participating ambulatory clinics (Primary Care, Adolescent Medicine, Developmental Medicine, Neurology, Psychiatry)
  • Patient's primary caregiver enrolled in TriVox

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAsthmaAutism Spectrum DisorderDepressionEpilepsyChronic Disease

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChild Development Disorders, PervasiveBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eugenia Chan, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Eric Fleegler, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 27, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations