Liver TransplantNCT01696331
Text Messaging for Adherence in Adolescent Liver Transplant Recipients
A study testing Text Message Reminder in people with Liver Transplant and Adherence, run by Stanford University at 1 site in United States.
Trial summary
Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Liver Transplant, Adherence
- What is being tested?
- Text Message Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2013
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient >12 years
- Received liver transplant
- Followed by Stanford Liver Transplant Team
Who cannot join
- No personal cell phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: Impact of Text Messaging on Adherence in Adolescent Liver Transplant Patients
Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients.
Read the detailed description
Adolescent patients who received a liver transplant will be recruited to participate in receiving text message reminders for lab tests. They will be send de-identified messages according to their required lab schedule. The investigators will monitor their adherence to lab tests as well as medication and clinic visits. They will also have a questionnaire about their medical regimen before and at the end of the study.
- Conditions
- Liver Transplant, Adherence
- Being tested
- Text Message Reminder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message ReminderBehavioural
Sent TM reminder at beginning and end of each month that corresponded to required lab frequency. Patients were able to send autoresponses.
| Study group | Role | What they receive |
|---|---|---|
| Text Message Reminder | Experimental | Not described Receives: Behavioral: Text Message Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to lab tests
Measured: One year
Secondary outcomes (1)
Texting responses
Correspondence between actual completion of tests versus reported
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 posted1 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Berquist McKenzie, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696331
- Sponsor's protocol ID
- 25318
- Status last verified
- Apr 2018
- First submitted
- 27 Sep 2012
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Text Messaging on Adherence in Adolescent Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT01696331
- Acronym / sponsor ID
- 25318
- Conditions
- Liver Transplant, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 1 Oct 2012 (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.
Text message reminders will improve adherence to lab tests in adolescent liver transplant recipients.
Detailed description
Adolescent patients who received a liver transplant will be recruited to participate in receiving text message reminders for lab tests. They will be send de-identified messages according to their required lab schedule. The investigators will monitor their adherence to lab tests as well as medication and clinic visits. They will also have a questionnaire about their medical regimen before and at the end of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Text Message Reminder | Experimental | Behavioral: Text Message Reminder |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient >12 years
- Received liver transplant
- Followed by Stanford Liver Transplant Team
Key exclusion criteria (1 listed)
- No personal cell phone
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 |
|---|---|---|
| Text Message ReminderSent TM reminder at beginning and end of each month that corresponded to required lab frequency. Patients were able to send autoresponses. | Behavioural | Text Message Reminder |
Primary outcome
Adherence to lab tests
Time frame: One year
1 secondary outcome
Texting responses
Time frame: 1 year
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 19 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Reminder in people with Liver Transplant and Adherence, 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 3 inclusion and 1 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 19 Apr 2018. 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?
Adherence to lab tests (time frame: One year). 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 19 Apr 2018.