PA Moves Trial- PCP Participants

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05319821
Collaborator
(none)
48
2
64

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Receive ECHO training
  • Behavioral: Offered ECHO training in year 5
N/A

Detailed Description

People living in rural areas are diagnosed and die from cancer at higher rates than people living in cities. Physical activity has been shown to decrease the risk and occurrence of a variety of cancers, including bladder, breast, colon, endometrial, gastric, kidney, and prostate cancers. Being inactive can cause over 10% of breast and colon cancer cases.

Compared to people living in cities, people living in rural areas tend to be less physically active. They're also more likely to be overweight/obese or have diabetes. Adults who are overweight, obese, or diabetic often have changes in the way their bodies deal with insulin, glucose metabolism, and inflammation. Physical activity is thought to reduce the risk of cancer by improving these issues over time.

PCPs and their staff can identify a patient's need for more physical activity, but may not have the time or resources to give advice or assistance. We have set up a telephone-based physical activity coaching program, called the MoveLine, to give inactive patients advice and assistance in becoming more physically active.

The purpose of this study is to determine if an ECHO intervention will impact the likelihood that PCPs will refer patients to the MoveLine for physical activity coaching.

Approximately 32-48 providers will take part in this research study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
PA Moves Trial- PCP Participants
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2028
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Intervention

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
Active Intervention

Active Comparator: Delayed Intervention

PCP participants will be offered the intervention in year 5.

Behavioral: Offered ECHO training in year 5
Delayed Intervention

Outcome Measures

Primary Outcome Measures

  1. Likelihood of patient referral [Through study completion, an average of 5 years]

    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

Secondary Outcome Measures

  1. PAQ-M [Baseline intervention group vs. Baseline delayed intervention group]

    The 11-question Morgenstern Physical Activity Questionnaire (PAQ-M) is a self-report of physical activity resulting from recreational activities, exercises, home or work activities, and chores.

  2. Estimated average metabolic equivalents expended daily [1 week at baseline]

    Daily metabolic equivalents collected using an accelerometer from Actigraph

  3. Estimated metabolic equivalents expended weekly [1 week at baseline]

    Weekly metabolic equivalents collected using an accelerometer from Actigraph, expressed in hours/week

  4. Time in Sleep [1 week at baseline]

    Weekly time in sleep collected using an accelerometer from Actigraph

  5. Sedentary Time [1 week at baseline]

    Weekly sedentary time collected using an accelerometer from Actigraph

  6. Low physical activity [1 week at baseline]

    Weekly low physical activity collected using an accelerometer from Actigraph

  7. Moderate physical activity [1 week at baseline]

    Weekly moderate physical activity collected using an accelerometer from Actigraph

  8. Vigorous physical activity [1 week at baseline]

    Weekly vigorous physical activity collected using an accelerometer from Actigraph

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Primary care providers or adjunct faculty from Primary Health Network (PHN) and Penn State Health Family and Community Medicine (FCM) rural clinics

  • Must be able to provide and understand informed consent

Exclusion Criteria:
  • Primary care providers or adjunct faculty NOT from PHN or FCM rural clinics

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Kathryn Schmitz, PhD, Penn State College of Medicine, Hershey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kathryn Schmitz, Professor, Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT05319821
Other Study ID Numbers:
  • STUDY00019602
First Posted:
Apr 8, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 27, 2022