Group Education Curriculum for Older Teens With Type 1 Diabetes (SMART T1D)
15. april 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Boston Children's Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
15 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Group
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
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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.
|
|
Ingen inngripen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline self-care adherence at 12 months
Tidsramme: 12 months
|
Measured by the Self-Care Inventory-Revised (SCI-R)
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline transition readiness at 12 months
Tidsramme: 12 months
|
Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)
|
12 months
|
|
Change from baseline hemoglobin A1c at 12 months
Tidsramme: 12 months
|
Measured by DCA Vantage
|
12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Katharine Garvey, MD, MPH, Boston Children's Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. mai 2017
Primær fullføring (Faktiske)
21. februar 2019
Studiet fullført (Faktiske)
21. februar 2019
Datoer for studieregistrering
Først innsendt
5. mai 2017
Først innsendt som oppfylte QC-kriteriene
8. mai 2017
Først lagt ut (Faktiske)
10. mai 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. april 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-P00023671
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared with other researchers
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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