Medication ComplianceNCT04382248
The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
A study testing Smartphone App and Tailored education in people with Medication Compliance, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation… Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Medication Compliance
- What is being tested?
- Smartphone App and Tailored education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 30 Nov 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1) age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
- 2) have and use a smartphone
- 3) patients without pre-formed antibodies
Who cannot join
- 1) Patients <12 or >40
- 2) patient with pre-existing antibodies
- 3) patients with rejection at the time of enrollment
- 4) patients without a smartphone
- 5) patients with developmental delay or psychological impairment and unable to use an app
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.
- Conditions
- Medication Compliance
- Being tested
- Smartphone App, Tailored education
- Keywords
- kidney transplant, teens, mobile app
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone AppOther
An app for monitoring medications, blood pressure, exercise, healthy eating
Tailored educationBehavioural
in-person coaching
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | An app for tracking medications, receiving personal coaching and educational material Receives: Other: Smartphone App; Behavioral: Tailored education |
| Control Group | Active comparator | An app for tracking medications Receives: Other: Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient activation scores as measured by Patient Activation Measure
0-100 scale that segments patients into one of four activation levels
Measured: baseline, 3 months, 6 months
Change in self-management as measured by Partners In Health survey
Measured: baseline, 3 months, 6 months
Secondary outcomes (6)
Medication adherence as measured by self-tracking
Measured: up to 6 months
Medication adherence as measured by blood levels
Measured: up to 6 months
Presence of cell-free DNA
Measured: up to 6 months
Presence of donor-specific antibodies
Measured: up to 6 months
Allograft function as measured by urine protein/creatinine ratio
Measured: up to 6 months
Allograft function as measured by serum creatinine
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start15 Oct 2020
- Primary completion31 Aug 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ComplianceStudies of the same condition, open and under way.
- More trials run by Duke 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- CareDx
- Responsible party
- Sponsor
- Investigators
- Eileen Chambers, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382248
- Sponsor's protocol ID
- Pro00104469
- Status last verified
- Feb 2022
- First submitted
- 5 May 2020
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation Self Management: The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04382248
- Acronym / sponsor ID
- Pro00104469
- Conditions
- Medication Compliance
- Keywords
- kidney transplant, teens, mobile app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- CareDx
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 11 May 2020 (actual)
- 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 examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Smartphone App, Behavioral: Tailored educationAn app for tracking medications, receiving personal coaching and educational material |
| Control Group | Active comparator | Other: Smartphone AppAn app for tracking medications |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 1) age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
- 2) have and use a smartphone
- 3) patients without pre-formed antibodies
Key exclusion criteria (5 listed)
- 1) Patients <12 or >40
- 2) patient with pre-existing antibodies
- 3) patients with rejection at the time of enrollment
- 4) patients without a smartphone
- 5) patients with developmental delay or psychological impairment and unable to use an app
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 |
|---|---|---|
| Smartphone AppAn app for monitoring medications, blood pressure, exercise, healthy eating | Other | Control Group, Interventional Group |
| Tailored educationin-person coaching | Behavioural | Interventional Group |
Primary outcome
Change in patient activation scores as measured by Patient Activation Measure
Time frame: baseline, 3 months, 6 months
0-100 scale that segments patients into one of four activation levels
Change in self-management as measured by Partners In Health survey
Time frame: baseline, 3 months, 6 months
6 secondary outcomes
Medication adherence as measured by self-tracking
Time frame: up to 6 months
Medication adherence as measured by blood levels
Time frame: up to 6 months
Presence of cell-free DNA
Time frame: up to 6 months
Presence of donor-specific antibodies
Time frame: up to 6 months
Allograft function as measured by urine protein/creatinine ratio
Time frame: up to 6 months
Allograft function as measured by serum creatinine
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Eileen Chambers, MD principal investigator
Duke 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 Smartphone App and Tailored education in people with Medication Compliance, run by Duke 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Feb 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient activation scores as measured by Patient Activation Measure (time frame: baseline, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.