A Pilot Study of mDOT for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03504137|
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence Kidney Transplant||Other: mHealth Intervention||Not Applicable|
In kidney transplant recipients, non-adherence to immunosuppressant medications post-transplant has been associated with a range of negative implications, including increased healthcare utilization, rejection of the graft, kidney loss, and death. Specifically, adolescents and young adults are the most at risk populations for experiencing death-censored graft loss and medication non-adherence. Previous studies have reported rates of non-adherence in this population ranging from 50-70%, and even minor deviations in immunosuppressant medication adherence have been shown to have negative effects. The use of mobile health (mHealth) technology could prove useful in aiding transplant recipients to stay adherent to their medical regimen.
We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to perform a pilot trial examining the rates of medication adherence in adolescent kidney transplant recipients who use a novel mHealth system, and to understand the acceptability/satisfaction with using this technology.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single center prospective control trial. Participants in this study will use the mHealth application to manage and track their immunosuppression medical regimen post-transplant.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adolescent Kidney Transplant Recipients|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2022|
Experimental: mHealth Intervention
Participants will receive the mHealth application either while they are an inpatient post-transplant, or at one of their post-transplant clinic visits. Study personnel will assist participants with downloading the mHealth application and explain its functioning. Participants will then use the application to aid in immunosuppressive medication adherence post-transplant.
Other: mHealth Intervention
The video DOT app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
- 12-week immunosuppression medication adherence [ Time Frame: 12 weeks ]After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.
- Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey [ Time Frame: 12 weeks ]After 12 weeks in the study, participants will be asked to participate in a semi-structured phone interview in which they will answer questions regarding their medication adherence habits and their thoughts on how our mHealth technology was or was not helpful. They will also complete a 17-question post-satisfaction survey assessing their satisfaction levels with the mhealth technology. Responses in the 17-item survey are on a 7-item Likert scale, ranging from Strongly Agree to Strongly Disagree.
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): NCT03504137
|Contact: Macey L Henderson, JD PhDfirstname.lastname@example.org|
|Contact: Cozumel S Pruette, MD MHS MSemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Macey L Henderson, JD PhD||Johns Hopkins University|