Trial Outcomes & Findings for A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients (NCT NCT04587024)

Last Updated: 2025-02-10

Results Overview

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). The investigators 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. The investigators will look at the difference in MLVIs between the two solid organ transplant groups. MLVI is the standard deviation of a series of at least three trough blood levels of tacrolimus or sirolimus. Higher MLVI value indicates greater variability in medication levels. MLVI \>=2 is suggestive of nonadherence and MLVI \<2 suggestive of adherence.

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

3 months

Results posted on

2025-02-10

Participant Flow

There were 75 enrolled patients, however 5 dropped out before randomization and therefore only 70 were randomized to the arms.

Participant milestones

Participant milestones
Measure	mHealth Intervention mHealth intervention mHealth intervention: Subjects will receive mHealth direct observation of therapy for 12 weeks	Standard of Care post-transplant standard of care standard of care: Subjects will receive standard of care observation for 12 weeks
Overall Study STARTED	36	34
Overall Study COMPLETED	36	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mHealth Intervention n=36 Participants mHealth intervention mHealth intervention: Subjects will receive mHealth direct observation of therapy for 12 weeks	Standard of Care n=34 Participants post-transplant standard of care standard of care: Subjects will receive standard of care observation for 12 weeks	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	52.5 years n=5 Participants	44 years n=7 Participants	48.5 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	13 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Nonadherence to immunosuppressant medication Non-adherent	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Nonadherence to immunosuppressant medication Adherent	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	mHealth Intervention n=36 Participants mHealth intervention mHealth intervention: Subjects will receive mHealth direct observation of therapy for 12 weeks	Standard of Care n=34 Participants post-transplant standard of care standard of care: Subjects will receive standard of care observation for 12 weeks
Medication Adherence Via Medication Level Variability Index (MLVI) MLVI >=2	23 Participants	24 Participants
Medication Adherence Via Medication Level Variability Index (MLVI) MLVI <2	10 Participants	8 Participants
Medication Adherence Via Medication Level Variability Index (MLVI) Missing	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

Clinical endpoint measuring the blood levels of tacrolimus (in ng/ml) that indicate rejection of transplant or not

Outcome measures

Outcome measures
Measure	mHealth Intervention n=36 Participants mHealth intervention mHealth intervention: Subjects will receive mHealth direct observation of therapy for 12 weeks	Standard of Care n=34 Participants post-transplant standard of care standard of care: Subjects will receive standard of care observation for 12 weeks
Blood Tacrolimus Levels	2.6 ng/ml Standard Deviation 0.87	2.37 ng/ml Standard Deviation 1.07

SECONDARY outcome

Timeframe: 3 months

Patient reported adherence depending on their scores from the immunosuppressant therapy instrument (ITAS questionnaire) will be measured. The ITAS is a four-item questionnaire that asks respondents to indicate how often they were non-adherent to immunosuppressant therapy (IST) given a particular circumstance. They are asked how often they: (i) forgot to take their IST medications; (ii) were careless about taking their IST medications; (iii) stopped taking their IST medications because they felt worse; and (iv) missed taking their IST medications for any reason. This is a binary measure where A stands for 0% of the time (none), B stands for 1%-20% of the time, C stands for 21-50% of the time, D stands for greater than 50% of the time. ITAS scores range from 0 to 12; 0 is the lowest score and 12 is the highest score, indicating perfect adherence.

Outcome measures

Outcome measures
Measure	mHealth Intervention n=36 Participants mHealth intervention mHealth intervention: Subjects will receive mHealth direct observation of therapy for 12 weeks	Standard of Care n=34 Participants post-transplant standard of care standard of care: Subjects will receive standard of care observation for 12 weeks
Patient Reported Adherence	12 score on a scale Standard Deviation 2	11 score on a scale Standard Deviation 2

Adverse Events

mHealth Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cozumel S. Pruette

Johns Hopkins University

Phone: 410-955-2467

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place