Do Technology Apps Improve Compliance in Adolescent Renal Transplant Recipients?
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 12 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | April 2016 |
| Contact: | Ha Tran, MD |
| Email: | hatran@stanford.edu |
| Phone: | 650-723-7903 |
The purpose of this study is to empower adolescent renal transplant recipients to fully
understand their medical condition as well as to help them acquire the skills to maintain a
healthy allograft well into adulthood. It is hoped that introducing technological
applications (apps) will assist adolescents in managing medications, clinic appointments,
lab appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise
frequency. The investigators aim to improve adolescent post-renal transplant outcomes
(increase medication adherence, lower clinic and laboratory no-show rate, lower blood
pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of
allograft rejection, decrease hospitalizations) as well as reduce cost.
understand their medical condition as well as to help them acquire the skills to maintain a
healthy allograft well into adulthood. It is hoped that introducing technological
applications (apps) will assist adolescents in managing medications, clinic appointments,
lab appointments, and in tracking fluid intake, blood pressure, caloric intake, and exercise
frequency. The investigators aim to improve adolescent post-renal transplant outcomes
(increase medication adherence, lower clinic and laboratory no-show rate, lower blood
pressure and BMI, maintain creatinine clearance, decrease proteinuria, decrease incidence of
allograft rejection, decrease hospitalizations) as well as reduce cost.
The research team as well and principal investigator will identify and verify patient
eligibility. Patients who are unable to speak or converse via sign language will be
excluded. All participants will need to provide informed written consent.
For recruitment and informed consent, the expected benefits, risks, and uncertainties will
be discussed with participants and their families. Participants will be offered enrollment
in either the randomized trial or a concurrent observational cohort, which may be more
feasible for families who live further away and have alternative insurance plans (Kaiser).
The results of the concurrent observational cohort can be reported at a later time.
Enrollment will begin in April 2015 and end in April 2016. This is to ensure that patients
who may miss an appointment can still be recruited in the following months.
Baseline variables will be collected prior to randomization including questionnaire and
baseline characteristics such as age, creatinine, weight, height, BMI, urine
protein-to-creatinine ratio, donor specific antibody levels, and blood pressure will be
recorded. Blood draws will be done per standard of care only and blood samples will not be
stored for research purposes. Computer-generated random treatment assignments will be made
based on permuted blocks (randomly generated blocks of 3).
The experimental arm will have all participants attend monthly renal transplant adolescent
clinic where the participant will undergo a 25-question baseline questionnaire focusing on
the participant's current knowledge of own medical condition, medications, medication
dosage, insurance coverage, daily fluid goal, blood pressure goal, voiding schedule, etc.
During each clinic visit, the participant will take the questionnaire and review results
with the transplant/research coordinator. The transplant/research coordinator will also
assist the participant in updating medication list, medication schedule, lab schedule,
clinic appointment schedule, pharmacy refill schedule etc. using an electronic device with
downloadable mobile apps. The included apps will be MyFitnessPal, a calorie counter and
exercise tracker, Blood Pressure Lite (Codulis) for blood pressure recording, and Med Coach
(GreatCall, Inc), providing medication and appointment reminders. If the participant already
has a personal i-Phone, the study coordinator will assist the participant add schedules to
the calendar and help set alarms and reminders. The research coordinator will also help
download free mobile apps that will log BP, fluid intake, caloric intake, and exercise
duration. If the participant does not have an i-Phone, an i-Pad Mini will be provided and
the transplant coordinator will assist with all that as stated above. The participant will
be seen by a nephrologist, social worker, and psychologist.
The non-technological group participants will also attend monthly renal transplant
adolescent clinic where he/she will undergo the same 25-question baseline questionnaire.
During each clinic visit, the participant will take the questionnaire and review results
with the research coordinator. The transplant coordinator will also assist the participant
in updating medication list, medication schedule, lab schedule, clinic appointment schedule,
pharmacy refill schedule etc. using paper calendar and pre-printed paper logs per the
routine care protocol. The participant will also be seen by a nephrologist, social worker,
and psychologist.
The primary measure is performance on monthly medical knowledge questionnaire, used as a
surrogate marker for readiness to transition to adult care. Secondary measures include
medication adherence measured by immunosuppression target drug levels, clinic and laboratory
no-show rates, markers of graft function measured by blood pressure readings, BMI,
creatinine clearance, urine protein-to-creatinine ratio, and episodes of rejections measured
by donor specific antibodies, and pathologic findings of allograft biopsy. The study will
end after the one year follow up period is completed. As the paper-based strategy is to
function as a control, the investigators do not anticipate an early termination to the
study, particularly since both groups provide more intervention than the current standard of
care.
eligibility. Patients who are unable to speak or converse via sign language will be
excluded. All participants will need to provide informed written consent.
For recruitment and informed consent, the expected benefits, risks, and uncertainties will
be discussed with participants and their families. Participants will be offered enrollment
in either the randomized trial or a concurrent observational cohort, which may be more
feasible for families who live further away and have alternative insurance plans (Kaiser).
The results of the concurrent observational cohort can be reported at a later time.
Enrollment will begin in April 2015 and end in April 2016. This is to ensure that patients
who may miss an appointment can still be recruited in the following months.
Baseline variables will be collected prior to randomization including questionnaire and
baseline characteristics such as age, creatinine, weight, height, BMI, urine
protein-to-creatinine ratio, donor specific antibody levels, and blood pressure will be
recorded. Blood draws will be done per standard of care only and blood samples will not be
stored for research purposes. Computer-generated random treatment assignments will be made
based on permuted blocks (randomly generated blocks of 3).
The experimental arm will have all participants attend monthly renal transplant adolescent
clinic where the participant will undergo a 25-question baseline questionnaire focusing on
the participant's current knowledge of own medical condition, medications, medication
dosage, insurance coverage, daily fluid goal, blood pressure goal, voiding schedule, etc.
During each clinic visit, the participant will take the questionnaire and review results
with the transplant/research coordinator. The transplant/research coordinator will also
assist the participant in updating medication list, medication schedule, lab schedule,
clinic appointment schedule, pharmacy refill schedule etc. using an electronic device with
downloadable mobile apps. The included apps will be MyFitnessPal, a calorie counter and
exercise tracker, Blood Pressure Lite (Codulis) for blood pressure recording, and Med Coach
(GreatCall, Inc), providing medication and appointment reminders. If the participant already
has a personal i-Phone, the study coordinator will assist the participant add schedules to
the calendar and help set alarms and reminders. The research coordinator will also help
download free mobile apps that will log BP, fluid intake, caloric intake, and exercise
duration. If the participant does not have an i-Phone, an i-Pad Mini will be provided and
the transplant coordinator will assist with all that as stated above. The participant will
be seen by a nephrologist, social worker, and psychologist.
The non-technological group participants will also attend monthly renal transplant
adolescent clinic where he/she will undergo the same 25-question baseline questionnaire.
During each clinic visit, the participant will take the questionnaire and review results
with the research coordinator. The transplant coordinator will also assist the participant
in updating medication list, medication schedule, lab schedule, clinic appointment schedule,
pharmacy refill schedule etc. using paper calendar and pre-printed paper logs per the
routine care protocol. The participant will also be seen by a nephrologist, social worker,
and psychologist.
The primary measure is performance on monthly medical knowledge questionnaire, used as a
surrogate marker for readiness to transition to adult care. Secondary measures include
medication adherence measured by immunosuppression target drug levels, clinic and laboratory
no-show rates, markers of graft function measured by blood pressure readings, BMI,
creatinine clearance, urine protein-to-creatinine ratio, and episodes of rejections measured
by donor specific antibodies, and pathologic findings of allograft biopsy. The study will
end after the one year follow up period is completed. As the paper-based strategy is to
function as a control, the investigators do not anticipate an early termination to the
study, particularly since both groups provide more intervention than the current standard of
care.
Inclusion Criteria:
- Adolescent patients between 12 and 18 years of age with kidney transplants seen at
Lucile Packard Children's Hospital for their transplant care at least every 3 months.
Exclusion Criteria:
- Non-English speaking,
- significant cognitive delays,
- seen in clinic less often than every 3 months.
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