A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT04587024|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence Liver Transplantation Kidney Transplantation||Other: mHealth intervention Other: standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||A Pilot Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients|
|Actual Study Start Date :||November 20, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2022|
Other: mHealth intervention
Subjects will receive mHealth direct observation of therapy for 12 weeks
Placebo Comparator: standard of care
post-transplant standard of care
Other: standard of care
Subjects will receive standard of care observation for 12 weeks
- Medication Adherence via Medication Level Variability Index (MLVI) [ Time Frame: 12 months ]To compare medication adherence of solid organ transplant recipients, specifically liver and kidney transplants, using the mobile DOT (mDOT) application (i.e., intervention) to those who did not use the mDOT application (i.e., control). We will compare medication adherence between intervention and control arms using the Medication Level Variability Index (MLVI), a validated measure of adherence derived from the standard deviation of measured drug levels. We will look at the difference in MLVIs between the two solid organ transplant groups.
- Blood tacrolimus levels [ Time Frame: 12 months ]Clinical endpoint measuring the blood levels of tacrolimus (in ng/ml) that indicate rejection of transplant or not
- Patient Reported Adherence [ Time Frame: 12 months ]Patient reported adherence depending on their scores from the immunosuppressant therapy instrument (ITAS questionnaire) will be measured. This is a binary measure where A stands for 0% none, B stands for 1%-20%, C stands for 21-50%, D stands for greater than 50%.
- Patient Reported QoL as assessed by the PedsQL [ Time Frame: 12 months ]Patient-reported QoL outcomes as measured by PedsQL to measure quality of life and medication adherence. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
- mHealth Usability Measurement [ Time Frame: 3 months ]Patient-reported usability measured using the Post-Study System Usability Questionnaire (PSSUQ), a 16-item questionnaire with score range of 1 to 16 with higher score indicating better usability. This will be done in the mHealth intervention arm only
- Patterns of Medication Adherence [ Time Frame: 12 months ]To examine the patterns of medication adherence in transplant recipients in both groups to better understand baseline medication adherence. We will be doing this by looking at the adherence streaks (number of doses taken over number of doses expected).
- Provider workflow as assessed by patient usage of the mDOT app [ Time Frame: 12 months ]Provider clinical workflow will be measured by evaluating patient usage on the app.
- Patient Reported QoL as assessed by the SF-36 [ Time Frame: 12 months ]Patient Reported QoL Short Form (SF)-36 to measure quality of life and medication adherence. The scoring is scaled at 0 as the lowest and 100 as the highest. The lower the score, the more disability.
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): NCT04587024
|Contact: Naureen Islamemail@example.com|
|Contact: Abigail Shegelmanfirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Not yet recruiting|
|Miami, Florida, United States, 33136|
|Contact: Lissett Moni LTueros@med.miami.edu|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Naureen Islam email@example.com|
|Contact: Abigail Shegelman firstname.lastname@example.org|
|United States, Virginia|
|University of Virginia||Not yet recruiting|
|Charlottesville, Virginia, United States, 22903|
|Contact: Robin Kelly RLK5A@hscmail.mcc.virginia.edu|
|Principal Investigator:||Douglas Mogul, MD, PhD||Johns Hopkins University|