Medication AdherenceNCT03515330
A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients
A study testing mHealth Intervention in people with Medication Adherence and Liver Transplant, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Medication Adherence, Liver Transplant
- What is being tested?
- mHealth Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 12 Nov 2020
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 22 years of age
- Receive a liver transplant at Johns Hopkins Hospital
Who cannot join
- Non-English speaking liver transplant recipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients
The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult liver transplant recipients at the Johns Hopkins Hospital.
Read the detailed description
In adult transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection, post-transplant complications, and increased healthcare costs. In adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to general medical indications (e.g. avoiding alcohol intake), is imperative to short- and long-term outcomes. The rate of non-adherence to immunosuppressant medications in this population varies vastly, with reports ranging from 15-40%. Because of lacking objective and accurate non-adherence measurements, the true implications and prevalence of non-adherence is not yet well understood. Therefore, the investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand non-adherence in adult liver transplant recipients. Additionally, an mHealth application with the ability to track symptoms, side effects, and alcohol cravings could provide clinicians with valuable information on post-transplant care.
We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth application against controls who do not.
- Conditions
- Medication Adherence, Liver Transplant
- Being tested
- mHealth Intervention
- Keywords
- mHealth, liver transplantation, medication adherence, video directly observed therapy
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth InterventionOther
The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants in the control arm will be instructed to take their immunosuppressant medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth application. |
| mHealth Intervention | Experimental | Participants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to aid in immunosuppressant medication adherence post-transplant. Receives: Other: mHealth Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week immunosuppression medication adherence
After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.
Measured: 12 weeks
Secondary outcomes (2)
Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey
After 12 weeks in the study, participants will be asked to participate in a semi-structured phone interview in which they will answer questions regarding their medication adherence habits and their thoughts on how our mHealth technology was or was not helpful. They will also complete a 17-question post-satisfaction survey assessing their satisfaction levels with the mhealth technology. Responses in the 17-item survey are on a 7-item Likert scale, ranging from Strongly Agree to Strongly Disagree.
Measured: 12 weeks
Alcohol Craving Assessment
As abstaining from alcohol is important following liver transplantation, we will administer a daily question through the mDOT app asking about alcohol craving and use. Patients who screen positive for alcohol craving and or use through the daily in-app question will be referred to a transplant social worker who will administer the Alcohol Craving Questionnaire Short Form.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start29 Jun 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Why it stopped: Merged IRB study created
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Model description
- This is a single center, prospective, randomized control trial with two arms. Participants in the intervention arm will use the mHealth app to manage and track their immunosuppression medical regimen post-transplant, and participants in the control arm will receive the current standard of follow-up care post-transplant.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Macey Henderson, JD, PhD, Principal investigator, Johns Hopkins UniversityAndrew Cameron, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515330
- Sponsor's protocol ID
- IRB00173000
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mor E, Gonwa TA, Husberg BS, Goldstein RM, Klintmalm GB. Late-onset acute rejection in orthotopic liver transplantation--associated risk factors and outcome. Transplantation. 1992 Nov;54(5):821-4. doi: 10.1097/00007890-199211000-00010.
PubMed 1279849O'Carroll RE, McGregor LM, Swanson V, Masterton G, Hayes PC. Adherence to medication after liver transplantation in Scotland: a pilot study. Liver Transpl. 2006 Dec;12(12):1862-8. doi: 10.1002/lt.20828.
PubMed 16773637Stilley CS, DiMartini AF, de Vera ME, Flynn WB, King J, Sereika S, Tarter RE, Dew MA, Rathnamala G. Individual and environmental correlates and predictors of early adherence and outcomes after liver transplantation. Prog Transplant. 2010 Mar;20(1):58-66; quiz 67. doi: 10.1177/152692481002000110.
PubMed 20397348Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x.
PubMed 19843035Burra P, Germani G, Gnoato F, Lazzaro S, Russo FP, Cillo U, Senzolo M. Adherence in liver transplant recipients. Liver Transpl. 2011 Jul;17(7):760-70. doi: 10.1002/lt.22294.
PubMed 21384527Laederach-Hofmann K, Bunzel B. Noncompliance in organ transplant recipients: a literature review. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):412-24. doi: 10.1016/s0163-8343(00)00098-0.
PubMed 11072057Hathaway DK, Combs C, De Geest S, Stergachis A, Moore LW. Patient compliance in transplantation: a report on the perceptions of transplant clinicians. Transplant Proc. 1999 Jun;31(4A):10S-13S. doi: 10.1016/s0041-1345(99)00113-x. No abstract available.
PubMed 10372033Dobbels F, Vanhaecke J, Desmyttere A, Dupont L, Nevens F, De Geest S. Prevalence and correlates of self-reported pretransplant nonadherence with medication in heart, liver, and lung transplant candidates. Transplantation. 2005 Jun 15;79(11):1588-95. doi: 10.1097/01.tp.0000158430.06507.87.
PubMed 15940050Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, Chaisson LH, Chaisson RE, Daley CL, Grzemska M, Higashi JM, Ho CS, Hopewell PC, Keshavjee SA, Lienhardt C, Menzies R, Merrifield C, Narita M, O'Brien R, Peloquin CA, Raftery A, Saukkonen J, Schaaf HS, Sotgiu G, Starke JR, Migliori GB, Vernon A. Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):853-67. doi: 10.1093/cid/ciw566.
PubMed 27621353Chisholm MA, Lance CE, Williamson GM, Mulloy LL. Development and validation of the immunosuppressant therapy adherence instrument (ITAS). Patient Educ Couns. 2005 Oct;59(1):13-20. doi: 10.1016/j.pec.2004.09.003.
PubMed 16198214Singleton, E.G., Tiffany, S.T. & Henningfield, J.E. (2000). Alcohol Craving Questionnaire (ACQ-NOW): Background, Scoring, and Administration (Manual). Baltimore, MD: Intramural Research Program, National Institute on Drug Abuse.
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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Mobile Directly Observed Therapy (mDOT) for Immunosuppressant Adherence in Adult Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT03515330
- Acronym / sponsor ID
- IRB00173000
- Conditions
- Medication Adherence, Liver Transplant
- Keywords
- mHealth, liver transplantation, medication adherence, video directly observed therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Merged IRB study created
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 3 May 2018 (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 investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult liver transplant recipients at the Johns Hopkins Hospital.
Detailed description
In adult transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection, post-transplant complications, and increased healthcare costs. In adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to general medical indications (e.g. avoiding alcohol intake), is imperative to short- and long-term outcomes. The rate of non-adherence to immunosuppressant medications in this population varies vastly, with reports ranging from 15-40%. Because of lacking objective and accurate non-adherence measurements, the true implications and prevalence of non-adherence is not yet well understood. Therefore, the investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand non-adherence in adult liver transplant recipients. Additionally, an mHealth application with the ability to track symptoms, side effects, and alcohol cravings could provide clinicians with valuable information on post-transplant care.
We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth application against controls who do not.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single center, prospective, randomized control trial with two arms. Participants in the intervention arm will use the mHealth app to manage and track their immunosuppression medical regimen post-transplant, and participants in the control arm will receive the current standard of follow-up care post-transplant.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants in the control arm will be instructed to take their immunosuppressant medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth application. |
| mHealth Intervention | Experimental | Other: mHealth InterventionParticipants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to aid in immunosuppressant medication adherence post-transplant. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than or equal to 22 years of age
- Receive a liver transplant at Johns Hopkins Hospital
Key exclusion criteria (1 listed)
- Non-English speaking liver transplant recipients
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 |
|---|---|---|
| mHealth InterventionThe mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. | Other | mHealth Intervention |
Primary outcome
12-week immunosuppression medication adherence
Time frame: 12 weeks
After 12 weeks in the study, patients will complete the 4-item immunosuppressant therapy adherence instrument (ITAS) to determine self-reported medication adherence (scores range from 0-12 with 0 indicating very poor adherence and 12 indicating perfect adherence). Additionally, immunosuppression level trends will be tracked via electronic medical record review to determine medication adherence.
2 secondary outcomes
Feasibility of using the mHealth Application as Assessed by a Semi-Structured Interview and a 17-Item Survey
Time frame: 12 weeks
Alcohol Craving Assessment
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Background: PubMed 1279849Mor E, Gonwa TA, Husberg BS, Goldstein RM, Klintmalm GB. Late-onset acute rejection in orthotopic liver transplantation--associated risk factors and outcome. Transplantation. 1992 Nov;54(5):821-4. doi: 10.1097/00007890-199211000-00010.
- Background: PubMed 16773637O'Carroll RE, McGregor LM, Swanson V, Masterton G, Hayes PC. Adherence to medication after liver transplantation in Scotland: a pilot study. Liver Transpl. 2006 Dec;12(12):1862-8. doi: 10.1002/lt.20828.
- Background: PubMed 20397348Stilley CS, DiMartini AF, de Vera ME, Flynn WB, King J, Sereika S, Tarter RE, Dew MA, Rathnamala G. Individual and environmental correlates and predictors of early adherence and outcomes after liver transplantation. Prog Transplant. 2010 Mar;20(1):58-66; quiz 67. doi: 10.1177/152692481002000110.
- Background: PubMed 19843035Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x.
- Background: PubMed 21384527Burra P, Germani G, Gnoato F, Lazzaro S, Russo FP, Cillo U, Senzolo M. Adherence in liver transplant recipients. Liver Transpl. 2011 Jul;17(7):760-70. doi: 10.1002/lt.22294.
- Background: PubMed 11072057Laederach-Hofmann K, Bunzel B. Noncompliance in organ transplant recipients: a literature review. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):412-24. doi: 10.1016/s0163-8343(00)00098-0.
- Background: PubMed 10372033Hathaway DK, Combs C, De Geest S, Stergachis A, Moore LW. Patient compliance in transplantation: a report on the perceptions of transplant clinicians. Transplant Proc. 1999 Jun;31(4A):10S-13S. doi: 10.1016/s0041-1345(99)00113-x. No abstract available.
- Background: PubMed 15940050Dobbels F, Vanhaecke J, Desmyttere A, Dupont L, Nevens F, De Geest S. Prevalence and correlates of self-reported pretransplant nonadherence with medication in heart, liver, and lung transplant candidates. Transplantation. 2005 Jun 15;79(11):1588-95. doi: 10.1097/01.tp.0000158430.06507.87.
- Background: PubMed 27621353Nahid P, Dorman SE, Alipanah N, Barry PM, Brozek JL, Cattamanchi A, Chaisson LH, Chaisson RE, Daley CL, Grzemska M, Higashi JM, Ho CS, Hopewell PC, Keshavjee SA, Lienhardt C, Menzies R, Merrifield C, Narita M, O'Brien R, Peloquin CA, Raftery A, Saukkonen J, Schaaf HS, Sotgiu G, Starke JR, Migliori GB, Vernon A. Executive Summary: Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):853-67. doi: 10.1093/cid/ciw566.
- Background: PubMed 16198214Chisholm MA, Lance CE, Williamson GM, Mulloy LL. Development and validation of the immunosuppressant therapy adherence instrument (ITAS). Patient Educ Couns. 2005 Oct;59(1):13-20. doi: 10.1016/j.pec.2004.09.003.
- BackgroundSingleton, E.G., Tiffany, S.T. & Henningfield, J.E. (2000). Alcohol Craving Questionnaire (ACQ-NOW): Background, Scoring, and Administration (Manual). Baltimore, MD: Intramural Research Program, National Institute on Drug Abuse.
- 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.
- 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.
Macey Henderson, JD, PhD principal investigator
Johns Hopkins University
Andrew Cameron, MD, PhD principal investigator
Johns Hopkins 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 mHealth Intervention in people with Medication Adherence and Liver Transplant, run by Johns Hopkins 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 2 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: withdrawn, as of the sponsor's last update on 23 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
12-week immunosuppression medication adherence (time frame: 12 weeks). 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 NCT03515330, which also lists 12 linked publications.
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 23 Sep 2021.