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Improving Transition Care for Adolescents and Young Adults with Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

Award Number: K23DK131368
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 07/07/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Improving Transition Care for Adolescents and Young Adults with Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2 - PROJECT SUMMARY / ABSTRACT For youth with type 1 diabetes (T1D), the transition into young adulthood is a high-risk period for deteriorations in glycemic control. T1D self-management, a key driver of glycemic control, is complicated by the transitional nature of this developmental period, which is associated with changes in multiple domains (i.e., biological, social, and environmental). Evidenced-based transition preparation interventions are needed prior to initiating adult healthcare to improve T1D self-management and glycemic control and increase transition readiness; however, evidence from rigorous trials is limited. To address this gap, we developed and conducted a single-arm pilot of SHIFT, a multisystem transition preparation intervention. Preliminary data from this pilot informed the current application, which proposes to conduct a randomized controlled trial (RCT) of a clinic-based transition preparation intervention (SHIFT2) for adolescents and young adults (AYAs) with T1D. Fifty AYAs (16-22 years) and a parent will be randomized to either: 1) a 6-month multisystem transition preparation program (SHIFT2), or 2) enhanced treatment as usual (TAU+). TAU+ includes usual T1D care, provider training, and standard patient education, matched to the intervention contact schedule. SHIFT2 will employ a hybrid delivery mode for intervention visits using clinic staff (Certified Diabetes Care and Education Specialists [CDCES]) and hospital- based technology platforms (e.g., virtual visits, patient portal). AYAs will receive evidence-based content across 3 domains: psychoeducation/skill building, behavioral self-management, and provider communication. Parents will receive psychoeducation and training in developmentally appropriate parenting strategies to support their AYA in increasing independent self-management and preparing for transition. Providers will receive a video module that highlights their role preparing AYAs for transition and provides evidence-based, practical tips to enhance communication with AYAs. In order to understand key stakeholders’ experiences regarding transitioning to adult care, qualitative interviews with a subset of AYAs who transitioned to adult care and their parents (n=20 AYA-parent dyads) and with providers (n=10 endocrinology providers and CDCES), will be conducted to inform further protocol refinement for future studies. This application has compelling scientific and clinical significance. It improves upon prior research via use of a rigorous RCT design, evidence-based intervention components within a multisystem framework, and objective assessment of the primary outcome (HbA1c). Findings will advance science and inform clinical recommendations regarding optimal strategies to promote independent T1D self-management in AYAs prior to transitioning to adult care. .


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $138,323 )
2026	2026	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	5/22/2026	NON-COMPETING CONTINUATION	$138,323
														Subtotal = $138,323

Issue Date FY: 2025 ( Subtotal = $140,643 )
2025	2025	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	5/20/2025	NON-COMPETING CONTINUATION	$140,643
														Subtotal = $140,643

Issue Date FY: 2024 ( Subtotal = $140,643 )
2024	2024	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/30/2024	NON-COMPETING CONTINUATION	$140,643
														Subtotal = $140,643

Issue Date FY: 2023 ( Subtotal = $140,643 )
2023	2023	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/17/2023	NON-COMPETING CONTINUATION	$140,643
														Subtotal = $140,643

Issue Date FY: 2022 ( Subtotal = $142,143 )
2022	2022	VIRGINIA COMMONWEALTH UNIVERSITY	912 W FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/7/2022	NEW	$142,143
														Subtotal = $142,143

Grand Total All Awards = $702,395

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Improving Transition Care for Adolescents and Young Adults with Type 1 Diabetes: A Randomized Controlled Trial of SHIFT2

Award Number: K23DK131368

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 07/07/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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