- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05254600
RISE RCT for Nurse Leaders (RISE)
June 27, 2023 updated by: AdventHealth
A Randomized Controlled Trial of RISE for Nurse Leaders
The purpose of this study is to determine whether RISE for Nurse Leaders has a significant impact on nurse leaders' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32804
- AdventHealth Orlando
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adult ≥ 18 years old
- Licensed as an RN
- Unit-based nurse leader (i.e., assistant nurse manager, nurse manager) employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Celebration, Daytona Beach, DeLand, East Orlando, Fish Memorial, Kissimmee, New Smyrna Beach, Orlando, Palm Coast, Waterman, or Winter Park campus
- Able to speak, read, and understand English fluently
- Able to provide informed consent
- Willing and able to comply with all study procedures and requirements for the duration of the study.
Exclusion Criteria:
- Employed as a direct care nurse or in another level of nursing leadership (i.e., director of nursing, executive leader)
- A study participant of IRBNet #1504917 titled A Pilot Study of RISE for Nurse Managers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Intervention group will attend the RISE for Nurse Leaders program, which consists of nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC)
|
Psychoeducational sessions designed to impact resilience, insight, self-compassion, and empowerment
|
Active Comparator: Wait-list control group
Control group will attend the RISE for Nurse Leaders program after the 3-month wait-list period
|
Psychoeducational sessions designed to impact resilience, insight, self-compassion, and empowerment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posttraumatic Growth Inventory
Time Frame: Group comparison from baseline to 3-month follow-up
|
21 item questionnaire with a scale of 0-5, with 0 meaning I did not experience this change as a result of my crisis; and 5 meaning I experienced this change to a very great degree as a result of my crisis
|
Group comparison from baseline to 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Index of Affective Job Satisfaction
Time Frame: Group comparison from baseline to 3-month follow-up
|
4 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
|
Group comparison from baseline to 3-month follow-up
|
Brief Resilience Scale
Time Frame: Group comparison from baseline to 3-month follow-up
|
6 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
|
Group comparison from baseline to 3-month follow-up
|
General Self-Efficacy Scale
Time Frame: Group comparison from baseline to 3-month follow-up
|
10 item questionnaire with a scale of 1-4, with 1 meaning not at all true; and 4 meaning exactly true
|
Group comparison from baseline to 3-month follow-up
|
Perceived Stress Scale
Time Frame: Group comparison from baseline to 3-month follow-up
|
10 item questionnaire with a scale of 0-4, with 0 meaning never; and 4 meaning very often
|
Group comparison from baseline to 3-month follow-up
|
Professional Quality of Life (ProQOL) Scale
Time Frame: Group comparison from baseline to 3-month follow-up
|
30 item questionnaire with a scale of 1-5 with 1 meaning never; and 5 meaning very often
|
Group comparison from baseline to 3-month follow-up
|
Psychological Empowerment Instrument
Time Frame: Group comparison from baseline to 3-month follow-up
|
12 item questionnaire with a scale of A-G, with A meaning very strongly disagree; and G meaning very strongly agree
|
Group comparison from baseline to 3-month follow-up
|
Self-Reflection and Insight Scale
Time Frame: Group comparison from baseline to 3-month follow-up
|
20 item questionnaire with a scale of 1-6; with 1 meaning strongly disagree; and 6 meaning strongly agree
|
Group comparison from baseline to 3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda T Sawyer, PhD, AdventHealth
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Kath LM, Stichler JF, Ehrhart MG. Moderators of the negative outcomes of nurse manager stress. J Nurs Adm. 2012 Apr;42(4):215-21. doi: 10.1097/NNA.0b013e31824ccd25.
- Kath LM, Stichler JF, Ehrhart MG, Sievers A. Predictors of nurse manager stress: a dominance analysis of potential work environment stressors. Int J Nurs Stud. 2013 Nov;50(11):1474-80. doi: 10.1016/j.ijnurstu.2013.02.011. Epub 2013 Mar 21.
- Labrague LJ, McEnroe-Petitte DM, Leocadio MC, Van Bogaert P, Cummings GG. Stress and ways of coping among nurse managers: An integrative review. J Clin Nurs. 2018 Apr;27(7-8):1346-1359. doi: 10.1111/jocn.14165. Epub 2018 Jan 24.
- Lee H, Cummings GG. Factors influencing job satisfaction of front line nurse managers: a systematic review. J Nurs Manag. 2008 Oct;16(7):768-83. doi: 10.1111/j.1365-2834.2008.00879.x.
- Shirey MR, McDaniel AM, Ebright PR, Fisher ML, Doebbeling BN. Understanding nurse manager stress and work complexity: factors that make a difference. J Nurs Adm. 2010 Feb;40(2):82-91. doi: 10.1097/NNA.0b013e3181cb9f88.
- Steege LM, Pinekenstein BJ, Arsenault Knudsen E, Rainbow JG. Exploring nurse leader fatigue: a mixed methods study. J Nurs Manag. 2017 May;25(4):276-286. doi: 10.1111/jonm.12464. Epub 2017 Feb 27.
- Warshawsky NE, Havens DS. Nurse manager job satisfaction and intent to leave. Nurs Econ. 2014 Jan-Feb;32(1):32-9.
- Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. (pp. 35-37). Windsor, UK: NFER-NELSON
- • Grant AM, Franklin J, Langford P. The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality. 2002; 30(8): 821-836.
- • Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4(4): 287-291.
- • Spreitzer GM. Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal. 1995; 38(5):1442-1465.
- • Stamm, B. H. (2009). Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL). http://www.proqol.org.
- • Thompson ER & Phua FTT. A Brief Index of Affective Job Satisfaction. Group & Organization Management. 2012; 37(3): 275-307.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2022
Primary Completion (Actual)
March 15, 2023
Study Completion (Actual)
May 15, 2023
Study Registration Dates
First Submitted
February 15, 2022
First Submitted That Met QC Criteria
February 15, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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