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WILD 5 Wellness: A 30-Day Intervention for Residents

Primary Purpose

Resident Wellness, Burnout, Professional, Medical Residents

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness
Sponsored by
Orange Park Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resident Wellness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants must be enrolled residents at Orange Park Medical Center (OPMC).

Exclusion Criteria:

  • Refusal to participate.

Sites / Locations

  • Orange Park Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

5-pronged wellness approach

Arm Description

30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition

Outcomes

Primary Outcome Measures

Change in overall combined wellness score
Change in overall combined wellness score

Secondary Outcome Measures

Change in Patient Health Questionnaire-9 (PHQ-9)
A self-reported depression scale used to assess severity of depression.
Change in Generalized Anxiety Disorder-7 (GAD-7)
A self-reported questionnaire used to assess anxiety symptoms.
Change in World Health Organization-5 (WHO-5)
A brief scale that measures mental well- being.
Change in The Sleep Condition Indicator (SCI)
A brief scale that evaluates insomnia disorder.
Change in The Social Connectedness Scale (SCS)
A brief scale that assesses the degree to which respondents feel connected to others.
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Change in The WILD 5 Wellness Scale (W5WS)
A brief scale designed specifically for this project to measure wellness.
The Post-Program Participant Questionnaire
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.

Full Information

First Posted
April 15, 2019
Last Updated
April 15, 2019
Sponsor
Orange Park Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03918083
Brief Title
WILD 5 Wellness: A 30-Day Intervention for Residents
Official Title
WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
April 10, 2022 (Anticipated)
Study Completion Date
April 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orange Park Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst resident physicians combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Detailed Description
Data from the initial pilot of Wild 5 Wellness data reported at the Annual US Psychiatric Congress Meeting demonstrated positive results with their 30-day intervention: This study uses compelling proof that even a non-medication, self-directed, low cost 30-day intervention, focusing on mental wellness offers clinically significant help with mood, anxiety, mindfulness, sleep, social connectivity, and emotional eating (Jain et al., 2015) The purpose of this study is to explore the efficacy and feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition. Data will be collected to evaluate participants' adherence and response to a 5-pronged 30-day wellness intervention. It is expected that this 30-day integrated, prescriptive, and trackable program will be found to be an efficacious wellness intervention among residents at OPMC. To the best of our knowledge, even though there is abundant research supporting each of the WILD 5 Wellness elements (exercise, mindfulness, sleep, social connectedness, and nutrition) individually, there is no research exploring the effectiveness of an integrated, prescriptive, and trackable wellness intervention combining these five elements. Therefore, this work will be unique in that it will collect both objective and subjective data to assess the feasibility and effectiveness of this type of wellness intervention. It will lend support to the growing body of research on the efficacy of wellness interventions for a variety of different health conditions, as well as a residency-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving resident wellness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resident Wellness, Burnout, Professional, Medical Residents, Mental Health Wellness 1, Mental Health Disorder, Resident Physician

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
WILD 5 Wellness is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5-pronged wellness approach
Arm Type
Other
Arm Description
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
Intervention Type
Behavioral
Intervention Name(s)
Wellness
Intervention Description
Assess the feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition.
Primary Outcome Measure Information:
Title
Change in overall combined wellness score
Description
Change in overall combined wellness score
Time Frame
0 and 31 days
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 (PHQ-9)
Description
A self-reported depression scale used to assess severity of depression.
Time Frame
0 and 31 days
Title
Change in Generalized Anxiety Disorder-7 (GAD-7)
Description
A self-reported questionnaire used to assess anxiety symptoms.
Time Frame
0 and 31 days
Title
Change in World Health Organization-5 (WHO-5)
Description
A brief scale that measures mental well- being.
Time Frame
0 and 31 days
Title
Change in The Sleep Condition Indicator (SCI)
Description
A brief scale that evaluates insomnia disorder.
Time Frame
0 and 31 days
Title
Change in The Social Connectedness Scale (SCS)
Description
A brief scale that assesses the degree to which respondents feel connected to others.
Time Frame
0 and 31 days
Title
Change in Eating and Appraisal Due to Emotions and Stress (EADES)
Description
A scale assessing how individuals cope with and appraise stress in relation to food and eating.
Time Frame
0 and 31 days
Title
Change in The WILD 5 Wellness Scale (W5WS)
Description
A brief scale designed specifically for this project to measure wellness.
Time Frame
0 and 31 days
Title
The Post-Program Participant Questionnaire
Description
A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
Time Frame
31 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants must be enrolled residents at Orange Park Medical Center (OPMC). Exclusion Criteria: Refusal to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AlexandraMary Kelada, DO, MPH
Phone
904-518-1164
Email
alexandramary.kelada@hcahealthcare.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Wombacher, PhD
Phone
9046392005
Email
kevin.wombacher@hcahealthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AlexandraMary Kelada, DO, MPH
Organizational Affiliation
Orange Park Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orange Park Medical Center
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Wombacher, PhD
Phone
904-639-2005
Email
kevin.wombacher@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
AlexandraMary Kelada, DO, MPH

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared.

Learn more about this trial

WILD 5 Wellness: A 30-Day Intervention for Residents

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