Hypertension, Medication Adherence, Renal Failure
Conditions
Keywords
renal failure, medication adherence, hypertension
Brief summary
Despite significant advances in the care of kidney transplant recipients, long term graft survival after renal transplantation remains suboptimal. Medication nonadherence and clinical inertia are key contributors to graft loss. The purpose of the proposed RCT feasibility study is to evaluate impact of a bundled wireless real time medication reminder system and blood pressure monitoring system in combination with a cognitive behavioral adherence skills enhancement program upon medication adherence, therapeutic drug concentration, and blood pressure, in nonadherent kidney transplant recipients with hypertension. We propose to recruit 60 kidney transplant recipients in phase 1 with 20 non-adherent continuing to phase 2 for a 5-month feasibility RCT.
Interventions
BEHAVIORALmHealth
mHealth prototype system consisting of electronic medication tray, blood pressure cuff and smart phone
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persons \> 21 years of age * first time recipient of a solitary kidney transplant * prescribed at least 3 medications for immunosuppression and hypertension * previous history of non-adherence * functioning kidney transplant * ability to speak, hear and understand English * able to use medication delivery device and self administer medications * able to operate blood pressure monitor * comfortable using cell phone * no other diagnosis that might shorten lifespan * transplant physician's assent that the patient can participate
Exclusion criteria
* failure to meet all inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| medication adherence | 5 months | adherence to immunosuppressive medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | 5 months | resting blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| acceptability | 5 months | patients' willingness to utilize the protocol mHealth system |
Countries
United States
Outcome results
None listed