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- Ensaio Clínico NCT04459728
KickStart30: A 30-Day Nursing Wellness Initiative
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Comportamental: Elemento de Bem-Estar 3 - Higiene do Sono
- Comportamental: Elemento de bem-estar 6 - Exercícios de bem-estar
- Comportamental: Elemento de Bem-Estar 7 - Mensagens Motivacionais
- Comportamental: Wellness Element 1: Exercise
- Comportamental: Wellness Element 2: Mindfulness
- Comportamental: Wellness Element 4 - Social Connectedness
- Comportamental: Wellness Element 5 - Nutrition
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
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Austin, Texas, Estados Unidos, 78701
- University of Texas at Austin
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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
Patrocinador
Investigadores
- Investigador principal: Saundra M Jain, PsyD, LPC, University of Texas at Austin
Publicações e links úteis
Publicações Gerais
- Jarrad R, Hammad S, Shawashi T, Mahmoud N. Compassion fatigue and substance use among nurses. Ann Gen Psychiatry. 2018 Mar 13;17:13. doi: 10.1186/s12991-018-0183-5. eCollection 2018.
- Mumba MN. Employment implications of nurses going through peer assistance programs for substance use disorders. Arch Psychiatr Nurs. 2018 Aug;32(4):561-567. doi: 10.1016/j.apnu.2018.03.001. Epub 2018 Mar 7.
- Rolin D, Fox I, Jain R, Cole SP, Tran C, Jain S. Wellness Interventions in Psychiatrically Ill Patients: Impact of WILD 5 Wellness, a Five-Domain Mental Health Wellness Intervention on Depression, Anxiety, and Wellness. J Am Psychiatr Nurses Assoc. 2020 Sep/Oct;26(5):493-502. doi: 10.1177/1078390319886883. Epub 2019 Nov 18.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020-05-0084
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Ensaios clínicos em Elemento de Bem-Estar 3 - Higiene do Sono
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