Smart Phone Medication Adherence Saves Kidneys--SMASK
Completed · Not applicable
Conditions studied: Kidney Transplantation, Medication Adherence, Hypertension
In brief
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers. Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Key facts
- Study ID
- NCT02827695
- Run by
- Medical University of South Carolina
- People needed
- 80
- Starts
- 2016-05-01
- Expected to finish
- 2020-08-31
- Last updated by the study team
- 2020-10-22
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥21 years old;
- First time recipient of a functioning solitary kidney transplant;
- Prescribed ≥3 medications for immunosuppression and HTN;
- Transplant MD's assent that patient is able to participate;
- Ability to speak, hear and understand English;
- Able to take their own BP;
- Self-administers medications;
- SBP >129 mmHg at clinic visit(s) in 4 weeks prior, and at initial study evaluation at enrollment;
- ***Only subjects with adherence score <.85 after 1-month screening and SBP >129 mmHg at baseline will be randomized.
You may not qualify if…
- Failure to meet any inclusion criterion;
- Ongoing substance abuse (e.g., >21 alcoholic drinks/week);
- Psychiatric illness requiring treatment beyond antidepressants;
- Will attempt to become pregnant within the year;
- Pregnant or nursing women, prisoners, and institutionalized persons.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.