NCT05319821

Brief Summary

The purpose of this voluntary research study is to determine the impact of an ECHO intervention on the likelihood that rural primary care providers (PCP) will refer their physically inactive patients to be more active.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress68%
Sep 2022Feb 2028

First Submitted

Initial submission to the registry

March 10, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 21, 2022

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

March 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5.3 years

First QC Date

March 10, 2022

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Likelihood of patient referral

    Percentage of participating primary care providers referring their patients to a community-level, telephone-based physical activity counseling service assessed through the EMR of their participating patients

    Through study completion, an average of 5 years

Secondary Outcomes (8)

  • PAQ-M

    Baseline intervention group vs. Baseline delayed intervention group

  • Estimated average metabolic equivalents expended daily

    1 week at baseline

  • Estimated metabolic equivalents expended weekly

    1 week at baseline

  • Time in Sleep

    1 week at baseline

  • Sedentary Time

    1 week at baseline

  • +3 more secondary outcomes

Study Arms (2)

Active Intervention

ACTIVE COMPARATOR

PCP participants in the practice cohort or the intervention group will receive the ECHO46 intervention via real-time, interactive videoconferencing through Zoom sessions held once weekly for 4 weeks (4 sessions total) at regularly scheduled times convenient to providers. Session topics will focus on training PCP participants to assess, advise, and refer patients to be more physically active, as well as provide evidence-based strategies they can use to supplement and sustain their communication efforts.

Behavioral: Receive ECHO training

Delayed Intervention

ACTIVE COMPARATOR

PCP participants will be offered the intervention in year 5.

Behavioral: Offered ECHO training in year 5

Interventions

Active Intervention

Active Intervention

Delayed Intervention

Delayed Intervention

Eligibility Criteria

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

You may qualify if:

  • Primary care providers or adjunct faculty from Primary Health Network (PHN) or UPMC clinics serving rural populations
  • Must be able to provide and understand informed consent

You may not qualify if:

  • \. Primary care providers or adjunct faculty NOT from PHN or UPMC clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

BehaviorMotor Activity

Study Officials

  • Kathryn Schmitz, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 10, 2022

First Posted

April 8, 2022

Study Start

September 21, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

March 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations