Kidney TransplantationNCT02610946
Do Technology Apps Improve Compliance in Adolescent Renal Transplant Recipients?
A study testing Electronic application and Paper-based in people with Kidney Transplantation, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Electronic application and Paper-based
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Non-English speaking,
- significant cognitive delays,
- seen in clinic less often than every 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University Hospital and Clinics
Palo Alto, California, 94305
Ha Tran, MD, 650-723-7903, hatran@stanford.edu
Priya Chandra, MD, 650-723-7903, priyac1@stanford.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Kidney Transplantation
- Being tested
- Electronic application, Paper-based
- Keywords
- pediatric, adolescent, compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic applicationBehavioural
Electronic application (app) based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.
Paper-basedBehavioural
Paper-based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.
| Study group | Role | What they receive |
|---|---|---|
| Paper-based | Placebo comparator | Use of paper-based calenders, reminders, medication list, and blood pressure, fluid intake tracking methods in adolescent renal transplant care Receives: Behavioral: Paper-based |
| Electronic application | Experimental | Use of electronic apps (iphone or i-Pad mini) to determine whether it can improve compliance with transplant care and readiness to transition to adult care. Receives: Behavioral: Electronic application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Ability to adhere to medical recommendations of transplant care assessed by presence or absence of antibody-mediated rejection based on donor-specific antibody levels.
Measured: 1 year
Secondary outcomes (1)
Readiness to transition
Knowledge of transplant care and readiness to transition to adult care assessed by questionnaire of disease knowledge base taken at baseline and at end of study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ha Tran, Stanford University
- Investigators
- Ha Tran, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610946
- Sponsor's protocol ID
- StanfordU TeenTransplant
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Technology Apps Improve Compliance in Adolescent Renal Transplant Recipients?
- ClinicalTrials.gov ID
- NCT02610946
- Acronym / sponsor ID
- StanfordU TeenTransplant
- Conditions
- Kidney Transplantation
- Keywords
- pediatric, adolescent, compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper-based | Placebo comparator | Behavioral: Paper-basedUse of paper-based calenders, reminders, medication list, and blood pressure, fluid intake tracking methods in adolescent renal transplant care |
| Electronic application | Experimental | Behavioral: Electronic applicationUse of electronic apps (iphone or i-Pad mini) to determine whether it can improve compliance with transplant care and readiness to transition to adult care. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-English speaking,
- significant cognitive delays,
- seen in clinic less often than every 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic applicationElectronic application (app) based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care. | Behavioural | Electronic application |
| Paper-basedPaper-based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care. | Behavioural | Paper-based |
Primary outcome
Compliance
Time frame: 1 year
Ability to adhere to medical recommendations of transplant care assessed by presence or absence of antibody-mediated rejection based on donor-specific antibody levels.
1 secondary outcome
Readiness to transition
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ha Tran, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic application and Paper-based in people with Kidney Transplantation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ha Tran, MD (650-723-7903, hatran@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.