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TAKE-IT TOO: Teen Adherence in KidnEy transplant Improving Tracking To Optimize Outcomes

Award Number: R01DK110737
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary: Medication non-adherence is a major problem in kidney transplant recipients, and is considered the most important factor limiting long-term graft survival; poor adherence results in significant morbidity, mortality and related costs. Young people 12-24 years of age are at particularly high risk for non- adherence and graft failure. Clinically feasible, effective interventions to improve adherence are urgently needed to improve survival and quality of life in this population. The goal of this prospective, 3-stage, sequential, multi-center study is to adapt the successful TAKE-IT intervention, previously tested in a controlled setting, for use in `real world' clinical care. We will apply the principles of user-centered design and use stakeholders' input to adapt the TAKE-IT intervention, and develop (in collaboration with Vaica Medical) a novel portable, multi-dose electronic medication-monitoring pillbox (e-pillbox). The specific aims of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for `real world' use; (2) To iteratively design and evaluate the usability and acceptability of an e-pillbox (with companion adherence- tracking website) with stakeholders in controlled and field settings; (3) To conduct a pilot cluster randomized trial (CRT) testing the adapted intervention, including the e-pillbox, to assess feasibility of a larger CRT, further refine the intervention, and estimate key statistical parameters needed to plan the future definitive CRT. In Stage 1 of this study, separate focus groups of patients and parents will be conducted at transplant centers in the United States and Canada to optimize effectiveness and acceptability of the multicomponent intervention and inform e-pillbox design. Focus groups with HCP will identify ways to facilitate implementation of an adherence-promoting intervention in clinical practice. In Stage 2, patients will participate in a series of one-on- one device-development sessions, providing input and feedback on the usability and design of the e-pillbox. HCP will also provide input and feedback on the design of the adherence-tracking website. In Stage 3 patients will be randomized, by center, to the new intervention, or usual care (control), and their adherence measured with the e-pillbox.


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: 2024 ( Subtotal = -$47,737 )
2024	2020	THE RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY	MONTREAL	QC			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	1/24/2024	NON-COMPETING CONTINUATION	-$47,737
														Subtotal = -$47,737

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY BUREAU 500	MONTREAL	QC			CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	5/27/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $521,136 )
2020	2020	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY BUREAU 500	MONTREAL	QC	H3H 2R9		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	6/23/2020	NON-COMPETING CONTINUATION	$521,136
														Subtotal = $521,136

Issue Date FY: 2019 ( Subtotal = $565,149 )
2019	2019	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY BUREAU 500	MONTREAL	QC	H3H 2R9		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	7/31/2019	NON-COMPETING CONTINUATION	$565,149
														Subtotal = $565,149

Issue Date FY: 2018 ( Subtotal = $571,568 )
2018	2018	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY BUREAU 500	MONTREAL	QC	H3H 2R9		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/18/2018	NON-COMPETING CONTINUATION	$571,568
														Subtotal = $571,568

Issue Date FY: 2017 ( Subtotal = $550,637 )
2017	2017	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE	2155 RUE GUY BUREAU 500	MONTREAL	QC	H3H 2R9		CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/12/2017	NON-COMPETING CONTINUATION	$550,637
														Subtotal = $550,637

Issue Date FY: 2016 ( Subtotal = $574,411 )
2016	2016	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CTR	RI MUHC MGH SITE ROOM S2-214	MONTREAL				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	8/8/2016	NEW	$23,328
2016	2016	RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CTR	RI MUHC MGH SITE ROOM S2-214	MONTREAL				CAN	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/4/2016	NEW	$551,083
														Subtotal = $574,411

Grand Total All Awards = $2,735,164

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TAKE-IT TOO: Teen Adherence in KidnEy transplant Improving Tracking To Optimize Outcomes

Award Number: R01DK110737

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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