Evidence map›Paper›PMID 30664485›Full record

ArticleJMIR research protocols2019

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

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

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Macey L HendersonDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0002-4239-1252
Alvin G ThomasDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0003-4911-8192
Ann K EnoDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0003-1338-9345
Madeleine M WaldramDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0001-5706-4353
Jaclyn BannonDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0001-7362-9545
Allan B MassieDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0002-5288-5125
Michael A LevanUnited Network for Organ Sharing, Richmond, VA, United States.ORCID http://orcid.org/0000-0002-9269-0963
Dorry L SegevDepartment of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, United States.ORCID http://orcid.org/0000-0002-1924-4801
Adam W BingamanThe Texas Transplant Institute, Methodist Specialty and Transplant Hospital, San Antonio, TX, United States.ORCID http://orcid.org/0000-0001-5521-8187
Johns Hopkins University · USCHRISTUS Transplant Institute · US

Funding

Cardiovascular Epidemiology Training GrantT32HL007055 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Wayne D. Rosamond · 1986 to 2026
$10.0M
Long-Term Health Outcomes After Live Kidney Donation in African AmericansR01DK096008 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI SEGEV, DORRY L. · 2013 to 2017
$3.8M
Patient Oriented Research in Kidney Disease and Transplant SurgeryK24DK101828 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI SEGEV, DORRY L. · 2014 to 2018
$922k
Technological Innovations for Live Kidney Donor Follow-up Care ManagementK01DK114388 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI LEVAN, MACEY LEIGH · 2017 to 2021
$720k
NHLBI NIH HHS T32 HL007055NIDDK NIH HHS K01 DK114388NIDDK NIH HHS K24 DK101828NIDDK NIH HHS R01 DK096008
6 · The paper itself

Abstract

backgroundEvery 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.

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

methodsWe 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.

resultsWe 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.

conclusionsThis 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11000.

Indexed as

appfollow-uphealth carekidney transplantationmHealthmobile phoneprotocolrandomized controlled trial

Identifiers

PMID30664485
PMCPMC6350092
OpenAlexW2898074438

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.