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Trial record 13 of 407 for:    Recruiting, Not yet recruiting, Available Studies | "Tissue Donors"

Pilot Study of an mHealth Intervention for Living Donor Follow-up (mHealth)

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ClinicalTrials.gov Identifier: NCT03400085
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Texas Transplant Institute
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of follow-up compliance among living kidney donors. The investigators aim to test this by randomly assigning living kidney donors to the intervention (use of mHealth application to complete required living kidney donor follow-up at 6 months, 1 year, and 2 years) or control arm (standard of care) upon discharge from their initial donation hospitalization, and tracking follow-up compliance over time. The study population will be approximately 400 living kidney donors who undergo donor nephrectomy at Methodist Specialty and Transplant Hospital (200/year for 2 years).

Condition or disease Intervention/treatment Phase
Living Donors Nephrectomy Kidney Other: mHealth application Not Applicable

Detailed Description:

Living kidney donation has been promoted as the 'best treatment option' for eligible patients with end-stage renal disease on the transplant waitlist by the American Society of Transplantation. In 2017, 5,264 living kidney donor (LKD) transplants were performed in the United States, representing over one-third of all kidney transplants performed nationally. While living donor nephrectomy is viewed as an overall safe procedure, the surgery does carry associated potential risks, including out-of-pocket costs, difficulty obtaining insurance, and long-term health complications. In 2013, the United Network for Organ Sharing (UNOS) passed new regulations requiring transplant hospitals to collect living kidney donor (LKD) follow-up data for a minimum of 2 years post-donation. Despite this national mandate, less than 50% of transplant hospitals were able to meet reporting thresholds for LKDs who donated in 2013. Documented challenges to collecting this data include cost, donor inconvenience, and data collection burden.

Therefore, novel methods are required to address incomplete donor follow-up. The investigators believe that mobile health (mHealth) systems, such as smartphone applications, would provide an effective, low-cost method of improving living donor follow-up rates. The investigators have built an mHealth system designed for reporting and collecting LKD follow-up data. The mHealth application was created based on previous studies conducted by the study team on the attitudes and perceptions of LKDs at a single transplant center on the use of mHealth for LKD follow-up, as well as after eliciting input from transplant thought leaders in the United States through semi-structured interviews. The aim of this study is to pilot test the mHealth system and compare the investigators' ability to achieve required follow-up at 6 months, 1 year, and 2 years against controls to help estimate potential effect sizes of the intervention.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single-center, prospective, randomized control trial with two arms. Participants in the intervention arm will use an mHealth application to complete their mandated living kidney donor follow-up at 6 months, 1 year, and 2 years, and participants in the control arm will receive the current standard of follow-up care and complete their required follow-up without the use of an mHealth application.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Mobile Health Intervention for Living Donor Follow-up
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
No Intervention: Standard of Care
The control participants will be instructed to attend required follow-up as is standard of care, and will not receive the mHealth application.
Experimental: mHealth application
Participants in the intervention arm will receive the mHealth application at their first post-donation clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to complete their required 6-month, 1-year, and 2-year follow-up.
Other: mHealth application
The intervention is an mHealth smartphone application designed for living kidney donors to complete their required 2-year follow-up. It allows the donor to input the answers to the clinical survey responses, as well as upload a picture of their lab values.
Other Name: Application




Primary Outcome Measures :
  1. 6-month compliance to follow-up [ Time Frame: 6 months ]
    Compliance with submitting questionnaires and laboratory values within 60 days of the six-month donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.

  2. 1-year compliance to follow-up [ Time Frame: 1 year ]
    Compliance with submitting questionnaires and laboratory values within 60 days of the 1-year donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.

  3. 2-year compliance to follow-up [ Time Frame: 2 years ]
    Compliance with submitting questionnaires and laboratory values within 60 days of the 2-year donation anniversary. Participants in the intervention arm will receive notifications when their follow-up is available to complete via the mHealth app, and subsequent notifications thereafter until either the donor completes both clinical and laboratory components of the required follow-up, or they are no longer compliant and within the 60-day window. Participants in the control arm will complete their follow-up as is current standard of care at Texas Transplant Institute.


Secondary Outcome Measures :
  1. 6-month center follow-up compliance [ Time Frame: 6 months ]
    Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the six-month donation anniversary.

  2. 1-year center follow-up compliance [ Time Frame: 1 year ]
    Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the 1-year donation anniversary.

  3. 2-year center follow-up compliance [ Time Frame: 2 years ]
    Overall center rate of compliance with follow-up with 80% of all donors within 60 days of the 2-year donation anniversary.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (≥18 years)
  • Have undergone live donor nephrectomy at Methodist Specialty and Transplant Hospital in San Antonio, Texas

Exclusion Criteria:

  • Participants will only be excluded if they do not consent to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400085


Contacts
Contact: Macey Henderson, JD, PhD 443-287-6649 macey@jhmi.edu
Contact: Dorry Segev, MD, PhD 443-287-4510 dorry@jhmi.edu

Locations
United States, Texas
Methodist Specialty and Transplant Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Adam Bingaman, MD    210-575-8425    adam.bingaman@mhshealth.com   
Sponsors and Collaborators
Johns Hopkins University
Texas Transplant Institute
Investigators
Principal Investigator: Macey Henderson, JD, PhD Johns Hopkins University

Publications:
Organ Procurement and Transplantation Network. National Data 2017.
OPTN Policy 18 Living Donor Data Submission Requirements. 2016: 220.

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03400085     History of Changes
Other Study ID Numbers: IRB00162212
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
mHealth
living donor kidney transplant
follow-up
health utilization