- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04459728
KickStart30: A 30-Day Nursing Wellness Initiative
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Conductual: Elemento de Bienestar 3 - Higiene del Sueño
- Conductual: Elemento de Bienestar 6 - Ejercicios de Bienestar
- Conductual: Elemento de Bienestar 7 - Mensajes Motivacionales
- Conductual: Wellness Element 1: Exercise
- Conductual: Wellness Element 2: Mindfulness
- Conductual: Wellness Element 4 - Social Connectedness
- Conductual: Wellness Element 5 - Nutrition
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Austin, Texas, Estados Unidos, 78701
- University of Texas at Austin
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervención de Bienestar
KickStart30 es una intervención de bienestar integrada, prescriptiva y rastreable que combina cinco elementos de bienestar que incluyen ejercicio, atención plena, sueño, conexión social y nutrición.
|
Elemento de bienestar diario centrado en la higiene del sueño; adherencia documentada en línea diariamente
Ejercicios diarios de bienestar que se enfocan en mejorar el bienestar mental; adherencia documentada en línea diariamente
Correos electrónicos motivacionales diarios que ofrecen información sobre uno de los 5 elementos de bienestar cada día (ejercicio, meditación consciente, sueño, conexión social y nutrición)
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in HERO Wellness Scale
Periodo de tiempo: 0, and 30 days
|
Brief scale that measures 4 wellness traits plus perceived mental wellness
|
0, and 30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cambio en el Trastorno de Ansiedad Generalizada-7 (GAD-7)
Periodo de tiempo: 0 y 30 días
|
El GAD-7 es un cuestionario de autoinforme de siete elementos para la detección y medición de la gravedad del trastorno de ansiedad generalizada.
Las puntuaciones van de 0 a 21 (puntuaciones más bajas = menos ansiedad).
|
0 y 30 días
|
Change in Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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),
Periodo de tiempo: 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)
Periodo de tiempo: 0, and 30 days
|
a 3-item screening tool for suicidality
|
0, and 30 days
|
Change in the Mindful Attention Awareness Scale (MAAS),
Periodo de tiempo: 0, and 30 days
|
a measure to assess mindfulness
|
0, and 30 days
|
Change in the Sleep Condition Indicator (SCI),
Periodo de tiempo: 0, and 30 days
|
a brief scale that assesses for insomnia disorder
|
0, and 30 days
|
Change in the Social Connectedness Scale (SCS),
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 0, and 30 days
|
a measurement tool for assessing clinical pain.
|
0, and 30 days
|
Change in the Sheehan Disability Scale (SDS),
Periodo de tiempo: 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)
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2020-05-0084
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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