跳至主要内容
临床试验/NCT04459728
NCT04459728已完成不适用

KickStart30: A 30-Day Nursing Wellness Initiative

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Change in HERO Wellness Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Licensed nurse in Texas Enrolled in TPAPN services/programs English-speaking Access to a reliable Internet-enabled computer Basic computer skills

排除标准

  • •Acutely suicidal and/or actively psychotic Non-English speaking Participants that are pregnant or plan to get pregnant during the next 30- days

研究组 & 干预措施

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 1: Exercise (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 2: Mindfulness (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 3 - Sleep Hygiene (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 4 - Social Connectedness (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 5 - Nutrition (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 6 - Wellness Exercises (Behavioral)

Wellness Intervention

Experimental

KickStart30 is an integrated, prescriptive, and trackable wellness intervention combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.

干预措施: Wellness Element 7 - Motivational Messages (Behavioral)

结局指标

主要结局

Change in HERO Wellness Scale

时间窗: 0, and 30 days

Brief scale that measures 4 wellness traits plus perceived mental wellness

次要结局

  • Change in Patient Health Questionnaire-9 (PHQ-9)(0, and 30 days)
  • Change in Generalized Anxiety Disorder-7 (GAD-7)(0, and 30 days)
  • Change in the Social Connectedness Scale (SCS),(0, and 30 days)
  • Change in the Cognitive and Physical Functioning Questionnaire (CPFQ)(0, and 30 days)
  • Change in the Short Inventory of Problems Revised (SIP-R),(0, and 30 days)
  • Change in Patient Safety Screener (PSS-3)(0, and 30 days)
  • Change in the Sleep Condition Indicator (SCI),(0, and 30 days)
  • Change in Brief Pain Inventory (BPI)(0, and 30 days)
  • Change in World Health Organization Well-Being Index (WHO-5)(0, and 30 days)
  • Change in the Mindful Attention Awareness Scale (MAAS),(0, and 30 days)
  • Change in the Eating and Appraisal Due to Emotions and Stress (EADES)(0, and 30 day)
  • Change in the Sheehan Disability Scale (SDS),(0, and 30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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