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KickStart30: A 30-Day Nursing Wellness Initiative

14 de julho de 2022 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

48

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Texas
      • Austin, Texas, Estados Unidos, 78701
        • University of Texas at Austin

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervenção de bem-estar
O KickStart30 é uma intervenção de bem-estar integrada, prescritiva e rastreável que combina cinco elementos de bem-estar, incluindo exercícios, atenção plena, sono, conexão social e nutrição.
Elemento de bem-estar diário com foco na higiene do sono; adesão documentada online diariamente
Exercícios diários de pasta de trabalho de bem-estar com foco na melhoria do bem-estar mental; adesão documentada online diariamente
E-mails motivacionais diários oferecendo informações sobre um dos 5 elementos de bem-estar todos os dias (exercício, meditação mindfulness, sono, conexão social e nutrição)
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in HERO Wellness Scale
Prazo: 0, and 30 days
Brief scale that measures 4 wellness traits plus perceived mental wellness
0, and 30 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Alteração no Transtorno de Ansiedade Generalizada-7 (GAD-7)
Prazo: 0 e 30 dias
O GAD-7 é um questionário de autorrelato de sete itens para triagem e medição da gravidade do transtorno de ansiedade generalizada. As pontuações variam de 0 a 21 (pontuações mais baixas = menos ansiedade).
0 e 30 dias
Change in Patient Health Questionnaire-9 (PHQ-9)
Prazo: 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)
Prazo: 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),
Prazo: 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)
Prazo: 0, and 30 days
a 3-item screening tool for suicidality
0, and 30 days
Change in the Mindful Attention Awareness Scale (MAAS),
Prazo: 0, and 30 days
a measure to assess mindfulness
0, and 30 days
Change in the Sleep Condition Indicator (SCI),
Prazo: 0, and 30 days
a brief scale that assesses for insomnia disorder
0, and 30 days
Change in the Social Connectedness Scale (SCS),
Prazo: 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)
Prazo: 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)
Prazo: 0, and 30 days
a measurement tool for assessing clinical pain.
0, and 30 days
Change in the Sheehan Disability Scale (SDS),
Prazo: 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)
Prazo: 0, and 30 days
a brief scale that measures cognitive and executive dysfunction
0, and 30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Saundra M Jain, PsyD, LPC, University of Texas at Austin

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de setembro de 2020

Conclusão Primária (Real)

5 de julho de 2022

Conclusão do estudo (Real)

14 de julho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de julho de 2020

Primeira postagem (Real)

7 de julho de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de julho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2022

Última verificação

1 de julho de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2020-05-0084

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Elemento de Bem-Estar 3 - Higiene do Sono

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