Ignite Creation Date:
2024-05-06 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03451240
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2018-02-05
Brief Title:
A Mixed Methods Evaluation of HPI Resilience Intervention Study
Sponsor:
Johnson Johnson Health and Wellness Solutions Inc
Organization:
Johnson Johnson Health and Wellness Solutions Inc
Study Overview
Official Title:
A Mixed Methods Evaluation of HPI Resilience Intervention Study
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the Resilience Study is to determine the impact of the Corporate Athlete Resilience product through recalibrating mindset and changing resilience supportive behavior
Analysis will be performed via Survey and Study Interviews two methods to determine how the CAR Training recalibrated and impacted the Research Participants mindset and resilience state
1 Tool Stress Mindset Measure-General SMM-G
Additional analysis will evaluate participants engagement in behavior changes in the first 30 days
2 Tool Energy Management Behaviors
Secondary objectives include further analysis to determine if the intervention group demonstrated significant improvements in the following measures
1 Brief Resilience Scale BRS
2 Public Health Surveillance Wellbeing PHS-WB
3 Sleep Habits Rand MOS
4 Health Wellbeing and Productivity SF36 HPQ
5 Work Productivity and Activity Impairment WPAI
6 Brief Cope
7 Perceived Stress PSS
In addition demographic assessments will be collected
Analysis will be performed via Survey and Study Interviews two methods to determine how the CAR Training recalibrated and impacted the Research Participants mindset and resilience state
1 Tool Stress Mindset Measure-General SMM-G
Additional analysis will evaluate participants engagement in behavior changes in the first 30 days
2 Tool Energy Management Behaviors
Secondary objectives include further analysis to determine if the intervention group demonstrated significant improvements in the following measures
1 Brief Resilience Scale BRS
2 Public Health Surveillance Wellbeing PHS-WB
3 Sleep Habits Rand MOS
4 Health Wellbeing and Productivity SF36 HPQ
5 Work Productivity and Activity Impairment WPAI
6 Brief Cope
7 Perceived Stress PSS
In addition demographic assessments will be collected
Detailed Description:
Methodology This is an interventional mixed methods qualitative amp quantitative study with pre-post design for research participants in one session All participants will be measured at two time points surveys will be collected between 3-weeks to the day of intervention for baseline 1-month post intervention
In addition Qualitative interviews will be conducted on a rolling basis between 3-60 days post intervention The qualitative portion is a semi-structured interview will be conducted with the purpose of understanding how participants recalibrated their mindset and impacting their resilience behaviors
Study Advertisement combined with the Resilience Program Advertisement will be posted by the Lake Nona Institute Potential Research Participants will be self-selected and will contact the Lake Nona Study Coordinator for additional information The self-selected individuals will receive HPI materials via mail in addition to Study and Resilience Program eligibility information
Potential Research Participants will undergo Screening and Consenting procedures at the Lake Nona Institute The Research Participant will be required to sign and date a paper based Informed Consent Document and provide additional contact information such as individual email address phone number etc
Enrolled Research Participants will be scheduled to attend the CAR Training Session
On the day of the CAR Training the Research Participants will receive a set of questionnaires as part of the Corporate Athlete Resilience Program HPI Questionnaire in addition to a set of Study Specific Questionnaires Study Questionnaire A description study activities Study Guide and a description of session activities Agenda consists of the introduction to stress and resilience session will be distributed to all Research Participants
30 days following the CAR Training the Research Participants will receive a follow-up HPI questionnaires and a Study questionnaires which will be utilized in the Resilience Research Study Analysis
3-60 days upon completion of the CAR Training the Research Participants will be asked to complete a Research Study Qualitative Telephone Video or Face-to-Face Interview Study Interview
In addition Qualitative interviews will be conducted on a rolling basis between 3-60 days post intervention The qualitative portion is a semi-structured interview will be conducted with the purpose of understanding how participants recalibrated their mindset and impacting their resilience behaviors
Study Advertisement combined with the Resilience Program Advertisement will be posted by the Lake Nona Institute Potential Research Participants will be self-selected and will contact the Lake Nona Study Coordinator for additional information The self-selected individuals will receive HPI materials via mail in addition to Study and Resilience Program eligibility information
Potential Research Participants will undergo Screening and Consenting procedures at the Lake Nona Institute The Research Participant will be required to sign and date a paper based Informed Consent Document and provide additional contact information such as individual email address phone number etc
Enrolled Research Participants will be scheduled to attend the CAR Training Session
On the day of the CAR Training the Research Participants will receive a set of questionnaires as part of the Corporate Athlete Resilience Program HPI Questionnaire in addition to a set of Study Specific Questionnaires Study Questionnaire A description study activities Study Guide and a description of session activities Agenda consists of the introduction to stress and resilience session will be distributed to all Research Participants
30 days following the CAR Training the Research Participants will receive a follow-up HPI questionnaires and a Study questionnaires which will be utilized in the Resilience Research Study Analysis
3-60 days upon completion of the CAR Training the Research Participants will be asked to complete a Research Study Qualitative Telephone Video or Face-to-Face Interview Study Interview
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None