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      The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial


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          Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders.


          The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates.


          We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system.


          We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period.


          This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations.

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          When patient activation levels change, health outcomes and costs change, too.

          Patient engagement has become a major focus of health reform. However, there is limited evidence showing that increases in patient engagement are associated with improved health outcomes or lower costs. We examined the extent to which a single assessment of engagement, the Patient Activation Measure, was associated with health outcomes and costs over time, and whether changes in assessed activation were related to expected changes in outcomes and costs. We used data on adult primary care patients from a single large health care system where the Patient Activation Measure is routinely used. We found that results indicating higher activation in 2010 were associated with nine out of thirteen better health outcomes-including better clinical indicators, more healthy behaviors, and greater use of women's preventive screening tests-as well as with lower costs two years later. Changes in activation level were associated with changes in over half of the health outcomes examined, as well as costs, in the expected directions. These findings suggest that efforts to increase patient activation may help achieve key goals of health reform and that further research is warranted to examine whether the observed associations are causal.
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            Health and the mobile phone.

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              OPTN/SRTR 2012 Annual Data Report: kidney.

              For most end-stage renal disease patients, successful kidney transplant provides substantially longer survival and better quality of life than dialysis, and preemptive transplant is associated with better outcomes than transplants occurring after dialysis initiation. However, kidney transplant numbers in the us have not changed for a decade. Since 2004, the total number of candidates on the waiting list has increased annually. Median time to transplant for wait-listed adult patients increased from 2.7 years in 1998 to 4.2 years in 2008. The discard rate of deceased donor kidneys has also increased, and the annual number of living donor transplants has decreased. The number of pediatric transplants peaked at 899 in 2005, and has remained steady at approximately 750 over the past 3 years; 40.9% of pediatric candidates undergo transplant within 1 year of wait-listing. Graft survival continues to improve for both adult and pediatric recipients. Kidney transplant is one of the most cost-effective surgical interventions; however, average reimbursement for recipients with primary Medicare coverage from transplant through 1 year posttransplant was comparable to the 1-year cost of care for a dialysis patient. Rates of rehospitalization are high in the first year posttransplant; annual costs after the first year are lower.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                January 2019
                15 January 2019
                : 8
                : 1
                : e11000
                [1 ] Department of Surgery Johns Hopkins University School of Medicine Baltimore, MD United States
                [2 ] Department of Acute and Chronic Care Johns Hopkins School of Nursing Baltimore, MD United States
                [3 ] Department of Epidemiology Johns Hopkins Bloomberg School of Public Health Baltimore, MD United States
                [4 ] United Network for Organ Sharing Richmond, VA United States
                [5 ] The Texas Transplant Institute Methodist Specialty and Transplant Hospital San Antonio, TX United States
                Author notes
                Corresponding Author: Macey L Henderson macey@ 123456jhmi.edu
                Author information
                ©Macey L Henderson, Alvin G Thomas, Ann K Eno, Madeleine M Waldram, Jaclyn Bannon, Allan B Massie, Michael A Levan, Dorry L Segev, Adam W Bingaman. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.01.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                : 8 May 2018
                : 8 July 2018
                : 3 October 2018
                : 4 October 2018

                app,follow-up,health care,kidney transplantation,mhealth,mobile phone,randomized controlled trial,protocol


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