KickStart30: A 30-Day Nursing Wellness Initiative

Study Overview
=================
Brief Summary
-----------------
This study explores the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of registered nurses in the state of Texas enrolled in the TExas Peer Assistance Program for Nurses (TPAPN). This 30-day wellness intervention (called KickStart30) combines five wellness elements: exercise,mindfulness, sleep, social connectedness, and nutrition. Additionally, the program requires that participants implement 5 wellness interventions daily for the 30-day study, document daily online adherence, complete daily HERO (happiness, enthusiasm, resilience, and optimism) exercises to improve mental wellness, and complete online program forms before and after the 30-day intervention. Participants are assessed pre- and post-intervention to determine whether the intervention promotes wellness behavior changes.

Detailed Description
-----------------
TPAPN is a voluntary program funded by the Texas Board of Nursing that provides early identification, support, monitoring, and accountability to Texas nurses who have an identified substance use and/or mental health condition or related incident. The goal of TPAPN is to help the nurse return to safe nursing practice. Currently, TPAPN does not offer a wellness intervention as part of their services. The purpose of this study is to explore the efficacy and feasibility of a self-management wellness intervention that is integrated, prescriptive, and trackable in a population of Texas nurses referred to a peer assistance monitoring program for an identified substance use and/or mental health condition or related incident. It is expected that this 30-day integrated, prescriptive, and trackable wellness intervention (combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition) will be found to be an efficacious program for those with nurses enrolled in TPAPN. Nurses are more susceptible to maladaptive coping behaviors, including turning to substance use or abuse, due to workplace stressors (Jarrad et al., 2018). Participating in a nursing monitoring program may increase stress in an already highly stressful profession; monitoring requirements alone can cause feelings of embarrassment and guilt (Mumba, 2018). It is the hope that adding the KickStart30 program, previously studied in a population with mental health issues (Rolin et al., 2019; NCT03993548) to the current offerings of TPAPN will result in the nurse replacing negative coping mechanisms with the positive coping mechanism, increasing long-term recovery and decreasing the likelihood of making an error in the workplace. To the best of our knowledge, even though there is abundant research supporting each of the KickStart30 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 specific to a cohort of nurses. 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 community-based population. Finally, it is hoped that positive results will yield increased access to and utilization of this type of intervention, thereby improving public health. The recruitment period will be open for 12 months to obtain a maximum of 50 participants. The study population will be nurses, ages 18 and older, interested in improving their overall wellness as part of the TPAPN program. Potential participants will be recruited via TPAPN Case Managers, Peer Support Partners, and Program Director who will provide recruitment flyers to potential participants. The study flyer will be posted to the TPAPN website as well as a informational video for potential participants to view. Interested individuals will be provided a toll-free phone number belonging to study personnel, which will be monitored daily Monday through Friday. Study personnel will reply to interested parties with a verbal screening/orientation call to determine eligibility. If the participant meets study criteria, the participant will be emailed a link to the online consent form, registration form, and program forms. Participants will have the option to download a PDF of their signed consent form for their records at the time of signing/completion. Study personnel will collect the participant's email address, physical mailing address, and assign the participant a unique identification code based on the order in which the participant was screened Study personnel will mail each participant a KickStart30 Workbook within one day of emailing participants their unique identification codes. Participants will be instructed to document adherence of their daily wellness practices and their daily HERO exercises online via Qualtrics, an online survey software. Participants can document their daily adherence using their computer and/or their smartphone as Qualtrics offers a mobile version of the Participant Tracking Form. A copy of the Participant Tracking Form will also be available in the KickStart30 Workbook so participants that prefer keeping a daily paper log can do so, and they can then transfer their program adherence information to the online Participant Tracking Form at their convenience throughout the program. The workbook will contain the participant's personal identification code; no personal identification will appear in the workbook in order to protect participant confidentiality. Participants will also receive daily motivational emails from MailChimp, which will provide general information about one of the five wellness elements and/or one of the HERO wellness traits, as well as encouragement to track their participation on a daily basis, and encouragement to contact study personnel via email with any questions and/or concerns. Data capture will occur at two points: once prior to beginning the study and again at the end of the 30-day study. Data will be collected online through program forms; all data will be hosted on Qualtrics, an online survey software. Program Forms assess items including depression, anxiety, wellbeing, mindfulness, sleep quality, social connectedness, emotional eating, pain, disability, physical function, cognition, substance and alcohol use, suicidality, happiness, enthusiasm, resilience, and optimism. Descriptive statistics will be used to discuss pre- and post-intervention scores. Differences between pretest and 30-day measures will be assessed with repeated measures ANOVA, with a p value of less than 0.05 indicating statistical significance.

Official Title
-----------------
KickStart30: A 30-Day Nursing Wellness Initiative

Conditions
-----------------
Substance Use

Intervention / Treatment
-----------------
* Behavioral: Wellness Element 1: Exercise
* Behavioral: Wellness Element 2: Mindfulness
* Behavioral: Wellness Element 3 - Sleep Hygiene
* Behavioral: Wellness Element 4 - Social Connectedness
* Behavioral: Wellness Element 5 - Nutrition
* Behavioral: Wellness Element 6 - Wellness Exercises
* Behavioral: Wellness Element 7 - Motivational Messages


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Licensed nurse in Texas Enrolled in TPAPN services/programs English-speaking Access to a reliable Internet-enabled computer Basic computer skills Exclusion Criteria: Acutely suicidal and/or actively psychotic Non-English speaking Participants that are pregnant or plan to get pregnant during the next 30- days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wellness Intervention<br>KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition. | Behavioral: Wellness Element 1: Exercise<br>* Daily wellness element focusing on Exercise; adherence documented online daily<br>Behavioral: Wellness Element 2: Mindfulness<br>* Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily<br>Behavioral: Wellness Element 3 - Sleep Hygiene<br>* Daily wellness element focusing on sleep hygiene; adherence documented online daily<br>Behavioral: Wellness Element 4 - Social Connectedness<br>* Daily wellness element focusing on social connectedness; adherence documented online daily<br>Behavioral: Wellness Element 5 - Nutrition<br>* Daily wellness element focusing on nutrition; adherence documented online daily<br>Behavioral: Wellness Element 6 - Wellness Exercises<br>* Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily<br>Behavioral: Wellness Element 7 - Motivational Messages<br>* Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HERO Wellness Scale | Brief scale that measures 4 wellness traits plus perceived mental wellness | 0, and 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 (PHQ-9) | The PHQ-9 is a nine-item depression self-report questionnaire for screening and measurement of severity of major depression. Scores range from 0-27 (lower scores = less depression) | 0, and 30 days | 
| Change in Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 is a seven-item self-report questionnaire for screening and measurement of severity of generalized anxiety disorder. Scores range from 0-21 (Lower scores = Less anxiety). | 0, and 30 days | 
| Change in World Health Organization Well-Being Index (WHO-5) | The WHO-5 Well-Being Index is a five-item self-report questionnaire covering 5 areas: positive mood, vitality, and general interests. Scores range from 0-25 (Higher scores = Higher levels of well-being) | 0, and 30 days | 
| Change in the Short Inventory of Problems Revised (SIP-R), | a 17-item inventory of adverse consequences associated with drug and alcohol use | 0, and 30 days | 
| Change in Patient Safety Screener (PSS-3) | a 3-item screening tool for suicidality | 0, and 30 days | 
| Change in the Mindful Attention Awareness Scale (MAAS), | a measure to assess mindfulness | 0, and 30 days | 
| Change in the Sleep Condition Indicator (SCI), | a brief scale that assesses for insomnia disorder | 0, and 30 days | 
| Change in the Social Connectedness Scale (SCS), | a brief scale that assesses social connectedness | 0, and 30 days | 
| Change in the Eating and Appraisal Due to Emotions and Stress (EADES) | an assessment of utilizing stress and coping skills in relation to food and eating utilizing stress and coping skills in relation to food and eating. | 0, and 30 day | 
| Change in Brief Pain Inventory (BPI) | a measurement tool for assessing clinical pain. | 0, and 30 days | 
| Change in the Sheehan Disability Scale (SDS), | a measurement tool for assessing functional impairment in three interrelated domains (work/school, social and family life.) | 0, and 30 days | 
| Change in the Cognitive and Physical Functioning Questionnaire (CPFQ) | a brief scale that measures cognitive and executive dysfunction | 0, and 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance Use, Registered Nurses, Wellness Programs