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First Responder Resiliency Program During COVID-19

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04536376
Collaborator
PNMedical (Industry)
10
Enrollment
1
Location
1
Arm
23.5
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluating a wellness program developed to provide effective sustainable solutions for medical professionals providing care to COVID-19 pandemic patients.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resilience Program
 N/A

Detailed Description

Providing mindfulness training at specific time points during study participation with an emphasis on integrating physical and mental health management. The phase-based program delivers individualized, data-driven and quantifiable solutions that directly address pain points impacting healthcare professionals and organizations.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
First Responder Resiliency Program for Health Care Professionals During a Pandemic
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
Sep 2, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Resilience Program

a 4 week program focused on improving resilience

Behavioral: Resilience Program
Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.

Outcome Measures

Primary Outcome Measures

  1. changes in biometric trends [4 weeks]

    changes in oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. 18 years of age or older at the time of consent

  2. Frontline healthcare professional

  3. Have access to an Apple or Android device

  4. Not pregnant by subject self-report at time of consent

  5. Have the ability to provide informed consent

  6. Have no contraindicating comorbid health condition as determined by the clinical investigators

Exclusion Criteria:

  1. Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis

  2. Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life or sleep

  3. Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, stress or sleep

  4. An unstable medical or mental health condition as determined by the physician investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • PNMedical

Investigators

  • Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic
  • Principal Investigator: Brent Bauer, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ivana Croghan, Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04536376
Other Study ID Numbers:
  • 20-005017
First Posted:
Sep 2, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 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 Feb 8, 2022