免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / WILD 5 Wellness: A 30-Day Intervention for Residents

WILD 5 Wellness: A 30-Day Intervention for Residents

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.

Condition or disease Intervention/treatment Phase
Resident Wellness Burnout, Professional Medical Residents Mental Health Wellness 1 Mental Health Disorder Resident Physician Behavioral: Wellness Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : April 10, 2022
Arms and Interventions
Arm Intervention/treatment
5-pronged wellness approach
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
Behavioral: Wellness
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.

Outcome Measures
Primary Outcome Measures :
  1. Change in overall combined wellness score [ Time Frame: 0 and 31 days ]
    Change in overall combined wellness score


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 0 and 31 days ]
    A self-reported depression scale used to assess severity of depression.

  2. Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 0 and 31 days ]
    A self-reported questionnaire used to assess anxiety symptoms.

  3. Change in World Health Organization-5 (WHO-5) [ Time Frame: 0 and 31 days ]
    A brief scale that measures mental well- being.

  4. Change in The Sleep Condition Indicator (SCI) [ Time Frame: 0 and 31 days ]
    A brief scale that evaluates insomnia disorder.

  5. Change in The Social Connectedness Scale (SCS) [ Time Frame: 0 and 31 days ]
    A brief scale that assesses the degree to which respondents feel connected to others.

  6. Change in Eating and Appraisal Due to Emotions and Stress (EADES) [ Time Frame: 0 and 31 days ]
    A scale assessing how individuals cope with and appraise stress in relation to food and eating.

  7. Change in The WILD 5 Wellness Scale (W5WS) [ Time Frame: 0 and 31 days ]
    A brief scale designed specifically for this project to measure wellness.

  8. The Post-Program Participant Questionnaire [ Time Frame: 31 days ]
    A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to participate.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: AlexandraMary Kelada, DO, MPH 904-518-1164 alexandramary.kelada@hcahealthcare.com
Contact: Kevin Wombacher, PhD 9046392005 kevin.wombacher@hcahealthcare.com

Locations
Layout table for location information
United States, Florida
Orange Park Medical Center Recruiting
Orange Park, Florida, United States, 32073
Contact: Kevin Wombacher, PhD    904-639-2005    kevin.wombacher@hcahealthcare.com   
Principal Investigator: AlexandraMary Kelada, DO, MPH         
Sponsors and Collaborators
Orange Park Medical Center
Investigators
Layout table for investigator information
Principal Investigator: AlexandraMary Kelada, DO, MPH Orange Park Medical Center
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date April 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Change in overall combined wellness score [ Time Frame: 0 and 31 days ]
Change in overall combined wellness score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 0 and 31 days ]
    A self-reported depression scale used to assess severity of depression.
  • Change in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 0 and 31 days ]
    A self-reported questionnaire used to assess anxiety symptoms.
  • Change in World Health Organization-5 (WHO-5) [ Time Frame: 0 and 31 days ]
    A brief scale that measures mental well- being.
  • Change in The Sleep Condition Indicator (SCI) [ Time Frame: 0 and 31 days ]
    A brief scale that evaluates insomnia disorder.
  • Change in The Social Connectedness Scale (SCS) [ Time Frame: 0 and 31 days ]
    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) [ Time Frame: 0 and 31 days ]
    A scale assessing how individuals cope with and appraise stress in relation to food and eating.
  • Change in The WILD 5 Wellness Scale (W5WS) [ Time Frame: 0 and 31 days ]
    A brief scale designed specifically for this project to measure wellness.
  • The Post-Program Participant Questionnaire [ Time Frame: 31 days ]
    A brief post study survey that captures participants' opinions about WILD 5 Wellness: 90-Day Intervention, and subjective ranking of their overall wellness.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WILD 5 Wellness: A 30-Day Intervention for Residents
Official Title  ICMJE WILD (WILD = Wellness Interventions for Life's Demands) 5 Wellness: A 30-Day Intervention for Residents
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Resident Wellness
  • Burnout, Professional
  • Medical Residents
  • Mental Health Wellness 1
  • Mental Health Disorder
  • Resident Physician
Intervention  ICMJE Behavioral: Wellness
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.
Study Arms  ICMJE 5-pronged wellness approach
30-day assessment of daily exercise, mindfulness, sleep, social connectedness, and nutrition
Intervention: Behavioral: Wellness
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 10, 2022
Estimated Primary Completion Date April 10, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: AlexandraMary Kelada, DO, MPH 904-518-1164 alexandramary.kelada@hcahealthcare.com
Contact: Kevin Wombacher, PhD 9046392005 kevin.wombacher@hcahealthcare.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918083
Other Study ID Numbers  ICMJE 2019-014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.
Responsible Party AlexandraMary Kelada, DO, MPH, Orange Park Medical Center
Study Sponsor  ICMJE Orange Park Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AlexandraMary Kelada, DO, MPH Orange Park Medical Center
PRS Account Orange Park Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP