Group Education Curriculum for Older Teens With Type 1 Diabetes (SMART T1D)
15 de abril de 2019 actualizado por: Katharine Garvey, Boston Children's Hospital
Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes
SMART T1D is a research study that offers interactive diabetes education for teens with type 1 diabetes in peer groups led by diabetes nurse educators.
Participants in the study will be randomly assigned to either receive three of the group sessions in addition to their routine clinic care or to receive their usual diabetes clinic care.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this 12-month pilot randomized controlled trial is to evaluate the impact of a 3-session group educational curriculum, compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes in the Boston Children's Hospital (BCH) Diabetes Program.
Adolescents (15-18 years) with T1D will be randomized to receive a 3-session group curriculum ("SMART T1D" - Self-Management, Adherence and Readiness for Transition in T1D) in addition to usual care (intervention group) or to receive usual care with individual diabetes visits (control group) and electronic newsletters to match for attention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Boston Children's Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Enrolled in the pediatric diabetes clinic at Boston Children's Hospital
- Age 15-18 years at enrollment
- Diabetes duration >1 year
- Ability to speak/read English
- Visits to any BCH Diabetes Program site ≥1 times over the past 6 months
- Hemoglobin A1c at clinic visit prior to enrollment 7.5%-11%
Exclusion Criteria:
- Major medical or psychiatric comorbidities
- Established patients of one of the diabetes nurse educators delivering the intervention
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
|
Patients randomized to the intervention group will attend 3 SMART T1D group curriculum sessions over the study period, in addition to usual diabetes clinic care.
Each interactive group session will last 2 hours and will be facilitated by a diabetes nurse educator.
|
|
Sin intervención: Control Group
These participants will receive no intervention.
They will have clinic care as usual and will receive three diabetes newsletters to match for attention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline self-care adherence at 12 months
Periodo de tiempo: 12 months
|
Measured by the Self-Care Inventory-Revised (SCI-R)
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12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline transition readiness at 12 months
Periodo de tiempo: 12 months
|
Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)
|
12 months
|
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Change from baseline hemoglobin A1c at 12 months
Periodo de tiempo: 12 months
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Measured by DCA Vantage
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12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Katharine Garvey, MD, MPH, Boston Children's Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Schwartz LA, Tuchman LK, Hobbie WL, Ginsberg JP. A social-ecological model of readiness for transition to adult-oriented care for adolescents and young adults with chronic health conditions. Child Care Health Dev. 2011 Nov;37(6):883-95. doi: 10.1111/j.1365-2214.2011.01282.x.
- Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631.
- Iannotti RJ, Schneider S, Nansel TR, Haynie DL, Plotnick LP, Clark LM, Sobel DO, Simons-Morton B. Self-efficacy, outcome expectations, and diabetes self-management in adolescents with type 1 diabetes. J Dev Behav Pediatr. 2006 Apr;27(2):98-105. doi: 10.1097/00004703-200604000-00003.
- Sawicki GS, Lukens-Bull K, Yin X, Demars N, Huang IC, Livingood W, Reiss J, Wood D. Measuring the transition readiness of youth with special healthcare needs: validation of the TRAQ--Transition Readiness Assessment Questionnaire. J Pediatr Psychol. 2011 Mar;36(2):160-71. doi: 10.1093/jpepsy/jsp128. Epub 2009 Dec 29.
- Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available. Erratum In: Diabetes Care. 2012 Jan;35(1):191.
- Bryden KS, Peveler RC, Stein A, Neil A, Mayou RA, Dunger DB. Clinical and psychological course of diabetes from adolescence to young adulthood: a longitudinal cohort study. Diabetes Care. 2001 Sep;24(9):1536-40. doi: 10.2337/diacare.24.9.1536.
- Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.
- Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.
- Bryden KS, Dunger DB, Mayou RA, Peveler RC, Neil HA. Poor prognosis of young adults with type 1 diabetes: a longitudinal study. Diabetes Care. 2003 Apr;26(4):1052-7. doi: 10.2337/diacare.26.4.1052.
- Floyd BD, Block JM, Buckingham BB, Ly T, Foster N, Wright R, Mueller CL, Hood KK, Shah AC. Stabilization of glycemic control and improved quality of life using a shared medical appointment model in adolescents with type 1 diabetes in suboptimal control. Pediatr Diabetes. 2017 May;18(3):204-212. doi: 10.1111/pedi.12373. Epub 2016 Feb 26.
- Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.
- Laing SP, Swerdlow AJ, Slater SD, Botha JL, Burden AC, Waugh NR, Smith AW, Hill RD, Bingley PJ, Patterson CC, Qiao Z, Keen H. The British Diabetic Association Cohort Study, I: all-cause mortality in patients with insulin-treated diabetes mellitus. Diabet Med. 1999 Jun;16(6):459-65. doi: 10.1046/j.1464-5491.1999.00075.x.
- Jacobson AM, Hauser ST, Willett J, Wolfsdorf JI, Herman L. Consequences of irregular versus continuous medical follow-up in children and adolescents with insulin-dependent diabetes mellitus. J Pediatr. 1997 Nov;131(5):727-33. doi: 10.1016/s0022-3476(97)70101-x.
- Wills CJ, Scott A, Swift PG, Davies MJ, Mackie AD, Mansell P. Retrospective review of care and outcomes in young adults with type 1 diabetes. BMJ. 2003 Aug 2;327(7409):260-1. doi: 10.1136/bmj.327.7409.260. No abstract available.
- Laing SP, Jones ME, Swerdlow AJ, Burden AC, Gatling W. Psychosocial and socioeconomic risk factors for premature death in young people with type 1 diabetes. Diabetes Care. 2005 Jul;28(7):1618-23. doi: 10.2337/diacare.28.7.1618.
- Lotstein DS, Seid M, Klingensmith G, Case D, Lawrence JM, Pihoker C, Dabelea D, Mayer-Davis EJ, Gilliam LK, Corathers S, Imperatore G, Dolan L, Anderson A, Bell RA, Waitzfelder B; SEARCH for Diabetes in Youth Study Group. Transition from pediatric to adult care for youth diagnosed with type 1 diabetes in adolescence. Pediatrics. 2013 Apr;131(4):e1062-70. doi: 10.1542/peds.2012-1450. Epub 2013 Mar 25.
- Helgeson VS, Reynolds KA, Snyder PR, Palladino DK, Becker DJ, Siminerio L, Escobar O. Characterizing the transition from paediatric to adult care among emerging adults with Type 1 diabetes. Diabet Med. 2013 May;30(5):610-5. doi: 10.1111/dme.12067. Epub 2013 Feb 28.
- Weissberg-Benchell J, Wolpert H, Anderson BJ. Transitioning from pediatric to adult care: a new approach to the post-adolescent young person with type 1 diabetes. Diabetes Care. 2007 Oct;30(10):2441-6. doi: 10.2337/dc07-1249. Epub 2007 Jul 31. No abstract available.
- Holmes-Walker DJ, Llewellyn AC, Farrell K. A transition care programme which improves diabetes control and reduces hospital admission rates in young adults with Type 1 diabetes aged 15-25 years. Diabet Med. 2007 Jul;24(7):764-9. doi: 10.1111/j.1464-5491.2007.02152.x. Epub 2007 May 29.
- Van Walleghem N, Macdonald CA, Dean HJ. Evaluation of a systems navigator model for transition from pediatric to adult care for young adults with type 1 diabetes. Diabetes Care. 2008 Aug;31(8):1529-30. doi: 10.2337/dc07-2247. Epub 2008 May 5.
- Lane JT, Ferguson A, Hall J, McElligott M, Miller M, Lane PH, Pfeffer E. Glycemic control over 3 years in a young adult clinic for patients with type 1 diabetes. Diabetes Res Clin Pract. 2007 Dec;78(3):385-91. doi: 10.1016/j.diabres.2007.04.014. Epub 2007 Jun 28.
- Logan J, Peralta E, Brown K, Moffett M, Advani A, Leech N. Smoothing the transition from paediatric to adult services in type 1 diabetes. J Diabetes Nurs. 2008;12:328-38.
- Orr DP, Fineberg NS, Gray DL. Glycemic control and transfer of health care among adolescents with insulin dependent diabetes mellitus. J Adolesc Health. 1996 Jan;18(1):44-7. doi: 10.1016/1054-139X(95)00044-S.
- American Academy of Pediatrics; American Academy of Family Physicians; American College of Physicians; Transitions Clinical Report Authoring Group; Cooley WC, Sagerman PJ. Supporting the health care transition from adolescence to adulthood in the medical home. Pediatrics. 2011 Jul;128(1):182-200. doi: 10.1542/peds.2011-0969. Epub 2011 Jun 27.
- Schwartz LA, Brumley LD, Tuchman LK, Barakat LP, Hobbie WL, Ginsberg JP, Daniel LC, Kazak AE, Bevans K, Deatrick JA. Stakeholder validation of a model of readiness for transition to adult care. JAMA Pediatr. 2013 Oct;167(10):939-46. doi: 10.1001/jamapediatrics.2013.2223.
- Lewin AB, LaGreca AM, Geffken GR, Williams LB, Duke DC, Storch EA, Silverstein JH. Validity and reliability of an adolescent and parent rating scale of type 1 diabetes adherence behaviors: the Self-Care Inventory (SCI). J Pediatr Psychol. 2009 Oct;34(9):999-1007. doi: 10.1093/jpepsy/jsp032. Epub 2009 May 7.
- Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997 May;20(5):760-6. doi: 10.2337/diacare.20.5.760.
- Khagram L, Martin CR, Davies MJ, Speight J. Psychometric validation of the Self-Care Inventory-Revised (SCI-R) in UK adults with type 2 diabetes using data from the AT.LANTUS Follow-on study. Health Qual Life Outcomes. 2013 Feb 26;11:24. doi: 10.1186/1477-7525-11-24.
- Markowitz JT, Laffel LM. Transitions in care: support group for young adults with Type 1 diabetes. Diabet Med. 2012 Apr;29(4):522-5. doi: 10.1111/j.1464-5491.2011.03537.x.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de mayo de 2017
Finalización primaria (Actual)
21 de febrero de 2019
Finalización del estudio (Actual)
21 de febrero de 2019
Fechas de registro del estudio
Enviado por primera vez
5 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2017
Publicado por primera vez (Actual)
10 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
15 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-P00023671
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared with other researchers
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Diabetes mellitus tipo 1
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University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
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University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes autoinmune | Diabetes Mellitus, Insulino-Dependiente | Diabetes de inicio juvenil | Diabetes Autoinmune | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | Diabetes Mellitus... y otras condicionesEstados Unidos
-
Capillary Biomedical, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Insulino-Dependiente, 1Australia
-
Spiden AGDCB Research AGReclutamientoDiabetes mellitus tipo 1 | Diabetes mellitus tipo 1 con hipoglucemia | Diabetes mellitus tipo 1 con hiperglucemiaSuiza
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...DesconocidoDiabetes mellitus tipo 1 con hiperglucemia | Diabetes mellitus tipo 1 con hipoglucemiaPolonia
-
Capillary Biomedical, Inc.TerminadoDiabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMAustria
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminadoDiabetes mellitus tipo 1 | DM1 | DT1 | Diabetes mellitus tipo 1 de nueva apariciónEstados Unidos, Australia
-
Shanghai Changzheng HospitalReclutamientoDiabetes mellitus frágil tipo 1Porcelana
-
SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
-
Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania
Ensayos clínicos sobre Intervention
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia