search
Back to results

Group Education Curriculum for Older Teens With Type 1 Diabetes (SMART T1D)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes Mellitus focused on measuring Diabetes Mellitus, Type 1, Adolescence

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.

These participants will receive no intervention. They will have clinic care as usual and will receive three diabetes newsletters to match for attention.

Outcomes

Primary Outcome Measures

Change from baseline self-care adherence at 12 months
Measured by the Self-Care Inventory-Revised (SCI-R)

Secondary Outcome Measures

Change from baseline transition readiness at 12 months
Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)
Change from baseline hemoglobin A1c at 12 months
Measured by DCA Vantage

Full Information

First Posted
May 5, 2017
Last Updated
April 15, 2019
Sponsor
Boston Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03147274
Brief Title
Group Education Curriculum for Older Teens With Type 1 Diabetes
Acronym
SMART T1D
Official Title
Evaluation of a Group Curriculum to Improve Self-Management Adherence and Transition Readiness in Older Teens With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes Mellitus, Type 1, Adolescence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a 12-month randomized controlled trial evaluating the impact of a health care delivery intervention ("SMART T1D" - a 3-session group educational curriculum), compared to standard care, on self-care adherence and transition readiness in adolescents with type 1 diabetes. Intervention (group sessions) and control (standard care) subjects will complete the study on a parallel timeline.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in this group will receive 3 group education sessions led by a diabetes nurse educator in addition to standard care.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
These participants will receive no intervention. They will have clinic care as usual and will receive three diabetes newsletters to match for attention.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline self-care adherence at 12 months
Description
Measured by the Self-Care Inventory-Revised (SCI-R)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline transition readiness at 12 months
Description
Measured by the Readiness for Independent Self-Care Questionnaire (RISQ)
Time Frame
12 months
Title
Change from baseline hemoglobin A1c at 12 months
Description
Measured by DCA Vantage
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Garvey, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers
Citations:
PubMed Identifier
12663572
Citation
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.
Results Reference
background
PubMed Identifier
10391392
Citation
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.
Results Reference
background
PubMed Identifier
9403654
Citation
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.
Results Reference
background
PubMed Identifier
12896937
Citation
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.
Results Reference
background
PubMed Identifier
11522695
Citation
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.
Results Reference
background
PubMed Identifier
15983310
Citation
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.
Results Reference
background
PubMed Identifier
23530167
Citation
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.
Results Reference
background
PubMed Identifier
23157171
Citation
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.
Results Reference
background
PubMed Identifier
22025785
Citation
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.
Results Reference
background
PubMed Identifier
17666466
Citation
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.
Results Reference
background
PubMed Identifier
17535294
Citation
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.
Results Reference
background
PubMed Identifier
18458141
Citation
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.
Results Reference
background
PubMed Identifier
17602780
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
8750427
Citation
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.
Results Reference
background
PubMed Identifier
21708806
Citation
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.
Results Reference
background
PubMed Identifier
23959392
Citation
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.
Results Reference
background
PubMed Identifier
22007989
Citation
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.
Results Reference
background
PubMed Identifier
27196443
Citation
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.
Results Reference
background
PubMed Identifier
25717281
Citation
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.
Results Reference
background
PubMed Identifier
26919322
Citation
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.
Results Reference
background
PubMed Identifier
19423660
Citation
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.
Results Reference
background
PubMed Identifier
15920050
Citation
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.
Results Reference
background
PubMed Identifier
20040605
Citation
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.
Results Reference
background
PubMed Identifier
9135939
Citation
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.
Results Reference
background
PubMed Identifier
12610013
Citation
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.
Results Reference
background
PubMed Identifier
16682872
Citation
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.
Results Reference
background
PubMed Identifier
23443007
Citation
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.
Results Reference
background
PubMed Identifier
22150392
Citation
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.
Results Reference
background

Learn more about this trial

Group Education Curriculum for Older Teens With Type 1 Diabetes

We'll reach out to this number within 24 hrs