NCT04499729

Brief Summary

The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

July 27, 2020

Last Update Submit

November 22, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depression

    Patient Health Questionnaire-9 (PHQ-9) assessment for depression

    Up to 20 Months

  • Number of assessments

    Number of Patient Health Questionnaire (PHQ-9) assessments acquired in the EHR

    Up to 20 Months

Secondary Outcomes (1)

  • First to last assessment

    Up to 20 Months

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

TAU will be the treatment that is provided through the Rush Collaborative Care program as part of their service

Behavioral: Treatment as Usual (TAU)

IntelliCare

EXPERIMENTAL

Patients will be offered IntelliCare as part of their care in the Rush Collaborative Care service. Patients who agree will download the IntelliCare app, which provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.

Device: IntelliCare

Interventions

IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.

IntelliCare

Treatment as usual in the Rush Collaborative Care service

Treatment as Usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in Rush Collaborative Care service
  • Owns a personal smartphone

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Carolyn MacIver

    Adaptive Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: We will utilize a pragmatic, system-wide rollout quality improvement evaluation design. Data from patients in the Rush Collaborative Care service will be used beginning Dec 1, 2019. The first care manager will begin offering IntelliCare as part of the collaborative care service in September, 2020, and one additional care manager will begin offering IntelliCare to patients every 3 months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

August 5, 2020

Study Start

December 1, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations