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KickStart30: A 30-Day Nursing Wellness Initiative

2022年7月14日 更新者:University of Texas at Austin
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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

48

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Texas
      • Austin、Texas、アメリカ、78701
        • University of Texas at Austin

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:健康介入
KickStart30 は、運動、マインドフルネス、睡眠、社会的つながり、栄養を含む 5 つの健康要素を組み合わせた、統合された処方的かつ追跡可能な健康介入です。
睡眠衛生に焦点を当てた毎日のウェルネス要素。毎日オンラインで文書化された遵守状況
精神的健康の改善に焦点を当てた毎日の健康ワークブック演習。毎日オンラインで文書化された遵守状況
毎日の健康の 5 つの要素 (運動、マインドフルネス瞑想、睡眠、社会的つながり、栄養) のいずれかに関する情報を提供する、モチベーションを高めるメール
Daily wellness element focusing on Exercise; adherence documented online daily
Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
Daily wellness element focusing on social connectedness; adherence documented online daily
Daily wellness element focusing on nutrition; adherence documented online daily

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in HERO Wellness Scale
時間枠:0, and 30 days
Brief scale that measures 4 wellness traits plus perceived mental wellness
0, and 30 days

二次結果の測定

結果測定
メジャーの説明
時間枠
全般性不安障害-7 (GAD-7) の変化
時間枠:0日、30日
GAD-7 は、全般性不安障害のスクリーニングと重症度の測定のための 7 項目の自己申告式アンケートです。 スコアの範囲は 0 ~ 21 (スコアが低いほど不安が少ない)。
0日、30日
Change in Patient Health Questionnaire-9 (PHQ-9)
時間枠:0, and 30 days
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 World Health Organization Well-Being Index (WHO-5)
時間枠:0, and 30 days
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),
時間枠:0, and 30 days
a 17-item inventory of adverse consequences associated with drug and alcohol use
0, and 30 days
Change in Patient Safety Screener (PSS-3)
時間枠:0, and 30 days
a 3-item screening tool for suicidality
0, and 30 days
Change in the Mindful Attention Awareness Scale (MAAS),
時間枠:0, and 30 days
a measure to assess mindfulness
0, and 30 days
Change in the Sleep Condition Indicator (SCI),
時間枠:0, and 30 days
a brief scale that assesses for insomnia disorder
0, and 30 days
Change in the Social Connectedness Scale (SCS),
時間枠:0, and 30 days
a brief scale that assesses social connectedness
0, and 30 days
Change in the Eating and Appraisal Due to Emotions and Stress (EADES)
時間枠:0, and 30 day
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)
時間枠:0, and 30 days
a measurement tool for assessing clinical pain.
0, and 30 days
Change in the Sheehan Disability Scale (SDS),
時間枠:0, and 30 days
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)
時間枠:0, and 30 days
a brief scale that measures cognitive and executive dysfunction
0, and 30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Saundra M Jain, PsyD, LPC、University of Texas at Austin

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年9月1日

一次修了 (実際)

2022年7月5日

研究の完了 (実際)

2022年7月14日

試験登録日

最初に提出

2020年7月2日

QC基準を満たした最初の提出物

2020年7月2日

最初の投稿 (実際)

2020年7月7日

学習記録の更新

投稿された最後の更新 (実際)

2022年7月18日

QC基準を満たした最後の更新が送信されました

2022年7月14日

最終確認日

2022年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2020-05-0084

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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