Medication AdherenceNCT04995770
Text Messages for Liver Transplant Recipients
A study testing Praise Text Messages in people with Medication Adherence and Liver Transplant Disorder, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
Although medical advancements have enabled children experiencing liver transplants to live longer, medical management post-transplant is ongoing and complex. Many findings underscore adolescents as being a particularly vulnerable population, with rates of nonadherence being four times higher than in adults. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Medication Adherence, Liver Transplant Disorder
- What is being tested?
- Praise Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 26 Dec 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 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- having a liver transplant
- receiving care at Children's Hospital Los Angeles
- having access to a working cellphone
- speaking English.
Who cannot join
- insufficient cognitive capacity to understand or engage in the procedures of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Text Messages for Adolescent and Young Adult Liver Transplant Recipients
Although medical advancements have enabled children experiencing liver transplants to live longer, medical management post-transplant is ongoing and complex. Many findings underscore adolescents as being a particularly vulnerable population, with rates of nonadherence being four times higher than in adults. This pilot study aims to explore the feasibility and impact of a brief text-messaging intervention in a randomized controlled trials (N = 50). We have three primary aims: 1) Study patient satisfaction with and utilization of this intervention in order to better understand feasibility and acceptability; 2) Investigate the effects of this intervention on medication adherence, healthcare utilization, and health status; and 3) Examine potential effects of the intervention on the physician-patient relationship, motivation for adherence, and other variables.
Read the detailed description
The proposed randomized control pilot study will be based at the Liver Transplant Clinic at CHLA. Approximately 25 participants will be randomly assigned to the intervention arm, whereas 25 participants will be assigned to treatment as usual (TAU), for a total sample size of N = 50. As there are approximately 90 patients who meet inclusion criteria currently in care, recruiting 50 for this study is feasible. The intervention will last for six months. During this time, participants in the intervention arm will receive a brief text-message on their cell-phones whenever laboratory blood tests indicate that immunosuppressant medications are within the expected range. This will primarily be measured via trough levels of calcineurin inhibitors, but will also take into account complete blood count, comprehensive metabolic panel, and magnesium level results, as reviewed by the transplant physician. The purpose of these text messages is to alert participants that physicians are indeed checking participant liver levels and recognizing when participants are putting in the work to keep themselves healthy. Multiple standardized text messages will be created so that participants do not receive identical ones each time. An example text message may include "Your liver levels have been checked and look good. The effort you are putting into taking your meds shows!" Participants in the TAU arm will not receive any text messages.If trough levels or any other study measure indicates possible nonadherence, nonadherence will still be addressed by their physicians, social work, or whatever is indicated per clinic standard of care. Furthermore, additional psychosocial or medical support will not be withheld from patients whose labs indicate nonadherence for either the intervention or TAU arms.
All participants will complete questionnaires at four points: Baseline, mid-way through the intervention period (three-months), immediately after the conclusion of the intervention (six-months), and three months post-intervention. Participants will complete self-report measures assessing medication adherence (Visual Analogue Scale), participants' sense of trust in their medical providers (Trust in Physician Scale) and motivation for medication adherence (Rollnick's Readiness Ruler). In addition, participants will complete self-reported measures of anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), and socioeconomic status (Family Affluence Scale II). Several variables will also be abstracted from the electronic medical record, from one year prior to study enrollment to one year post study enrollment. At the end of the intervention, participants will complete an exit survey assessing its feasibility and acceptability. They will be asked to discuss which components of the intervention were most helpful, so this information can be used for possible dismantling study approaches in the future. Twenty-five participants will also be randomly selected and asked to participate in a 30-60 minute telephone interview in order to assess feasibility and acceptability of the study, as well as gain their insight regarding potentially helpful future interventions. Medical or psychosocial support will not be withheld from patients who drop out of the study or do not complete study measures. All data will be collected via Redcap, a HIPAA-compliant on-line platform that will allow participants to complete measures securely on-line at home.
- Conditions
- Medication Adherence, Liver Transplant Disorder
- Being tested
- Praise Text Messages
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praise Text MessagesBehavioural
Texting messages with praise content, to positive reinforce medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Praise Text Messages | Experimental | The text message praise intervention lasted for 6 months. Each week, transplant coordinators, masked from who enrolled in the study or to which condition participants were randomized, prepared a list of all patients in the study age group whose laboratory blood tests indicated that immunosuppressant medications were within the expected range. A researcher reviewed the list to identify whether any of patients were currently assigned to the intervention, and if so, sent text message praise via REDCap's text message function. We rotated through 14 standardized text messages each week. Examples of messages included: "Your labs look very good. Super job taking your meds!" and "Your labs look great! Thanks for putting in the effort to take care of your health!." Receives: Behavioral: Praise Text Messages |
| Usual Care | No intervention | Participants in the usual care arm did not receive any praise text messages. All participants continued to receive usual care from the multidisciplinary liver transplant team, including phone calls and follow-up care when laboratory blood tests indicated that immunosuppressant medications were outside of the expected range. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Medication Adherence
Visual Analogue Scale (0-100% range, with higher scores indicating better values)
Measured: 9 months
Medication Variability Observed in Immunosuppressant Labs
medication level variability index (calculated as standard deviation of at least 3 lab values, with lower scores indicating better values)
Measured: 12 months
Secondary outcomes (1)
Motivation for Adherence
Rollnick's Readiness Ruler (0-10 range, with higher scores indicating better values)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Aug 2019
- Primary completion26 Dec 2020
- Study completion26 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Children's Hospital Los AngelesThe 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Sayegh, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995770
- Sponsor's protocol ID
- CHLA-19-00189
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh JC, Dalton M, Gazzard BG. Adherence to combination antiretroviral therapy assessed by anonymous patient self-report. AIDS. 1998 Dec 3;12(17):2361-3. No abstract available.
PubMed 9863888Rollnick S, Miller WR, Butler C. Motivational interviewing in health care: helping patients change behavior. Guilford Press; 2008.
Shemesh E, Fine RN. Is calculating the standard deviation of tacrolimus blood levels the new gold standard for evaluating non-adherence to medications in transplant recipients? Pediatr Transplant. 2010 Dec;14(8):940-3. doi: 10.1111/j.1399-3046.2010.01396.x. Epub 2010 Oct 1.
PubMed 20887400
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messages for Adolescent and Young Adult Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04995770
- Acronym / sponsor ID
- CHLA-19-00189
- Conditions
- Medication Adherence, Liver Transplant Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 26 Dec 2020 (actual)
- First posted
- 9 Aug 2021 (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.
Although medical advancements have enabled children experiencing liver transplants to live longer, medical management post-transplant is ongoing and complex. Many findings underscore adolescents as being a particularly vulnerable population, with rates of nonadherence being four times higher than in adults. This pilot study aims to explore the feasibility and impact of a brief text-messaging intervention in a randomized controlled trials (N = 50). We have three primary aims: 1) Study patient satisfaction with and utilization of this intervention in order to better understand feasibility and acceptability; 2) Investigate the effects of this intervention on medication adherence, healthcare utilization, and health status; and 3) Examine potential effects of the intervention on the physician-patient relationship, motivation for adherence, and other variables.
Detailed description
The proposed randomized control pilot study will be based at the Liver Transplant Clinic at CHLA. Approximately 25 participants will be randomly assigned to the intervention arm, whereas 25 participants will be assigned to treatment as usual (TAU), for a total sample size of N = 50. As there are approximately 90 patients who meet inclusion criteria currently in care, recruiting 50 for this study is feasible. The intervention will last for six months. During this time, participants in the intervention arm will receive a brief text-message on their cell-phones whenever laboratory blood tests indicate that immunosuppressant medications are within the expected range. This will primarily be measured via trough levels of calcineurin inhibitors, but will also take into account complete blood count, comprehensive metabolic panel, and magnesium level results, as reviewed by the transplant physician. The purpose of these text messages is to alert participants that physicians are indeed checking participant liver levels and recognizing when participants are putting in the work to keep themselves healthy. Multiple standardized text messages will be created so that participants do not receive identical ones each time. An example text message may include "Your liver levels have been checked and look good. The effort you are putting into taking your meds shows!" Participants in the TAU arm will not receive any text messages.If trough levels or any other study measure indicates possible nonadherence, nonadherence will still be addressed by their physicians, social work, or whatever is indicated per clinic standard of care. Furthermore, additional psychosocial or medical support will not be withheld from patients whose labs indicate nonadherence for either the intervention or TAU arms.
All participants will complete questionnaires at four points: Baseline, mid-way through the intervention period (three-months), immediately after the conclusion of the intervention (six-months), and three months post-intervention. Participants will complete self-report measures assessing medication adherence (Visual Analogue Scale), participants' sense of trust in their medical providers (Trust in Physician Scale) and motivation for medication adherence (Rollnick's Readiness Ruler). In addition, participants will complete self-reported measures of anxiety (General Anxiety Disorder-7), depression (Patient Health Questionnaire-9), and socioeconomic status (Family Affluence Scale II). Several variables will also be abstracted from the electronic medical record, from one year prior to study enrollment to one year post study enrollment. At the end of the intervention, participants will complete an exit survey assessing its feasibility and acceptability. They will be asked to discuss which components of the intervention were most helpful, so this information can be used for possible dismantling study approaches in the future. Twenty-five participants will also be randomly selected and asked to participate in a 30-60 minute telephone interview in order to assess feasibility and acceptability of the study, as well as gain their insight regarding potentially helpful future interventions. Medical or psychosocial support will not be withheld from patients who drop out of the study or do not complete study measures. All data will be collected via Redcap, a HIPAA-compliant on-line platform that will allow participants to complete measures securely on-line at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Praise Text Messages | Experimental | Behavioral: Praise Text MessagesThe text message praise intervention lasted for 6 months. Each week, transplant coordinators, masked from who enrolled in the study or to which condition participants were randomized, prepared a list of all patients in the study age group whose laboratory blood tests indicated that immunosuppressant medications were within the expected range. A researcher reviewed the list to identify whether any of patients were currently assigned to the intervention, and if so, sent text message praise via REDCap's text message function. We rotated through 14 standardized text messages each week. Examples of messages included: "Your labs look very good. Super job taking your meds!" and "Your labs look great! Thanks for putting in the effort to take care of your health!." |
| Usual Care | No intervention | –Participants in the usual care arm did not receive any praise text messages. All participants continued to receive usual care from the multidisciplinary liver transplant team, including phone calls and follow-up care when laboratory blood tests indicated that immunosuppressant medications were outside of the expected range. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- having a liver transplant
- receiving care at Children's Hospital Los Angeles
- having access to a working cellphone
- speaking English.
Key exclusion criteria (1 listed)
- insufficient cognitive capacity to understand or engage in the procedures of the study
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 |
|---|---|---|
| Praise Text MessagesTexting messages with praise content, to positive reinforce medication adherence | Behavioural | Praise Text Messages |
Primary outcome
Self-Reported Medication Adherence
Time frame: 9 months
Visual Analogue Scale (0-100% range, with higher scores indicating better values)
Medication Variability Observed in Immunosuppressant Labs
Time frame: 12 months
medication level variability index (calculated as standard deviation of at least 3 lab values, with lower scores indicating better values)
1 secondary outcome
Motivation for Adherence
Time frame: 9 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 23 Aug 2021.
- Background: PubMed 9863888Walsh JC, Dalton M, Gazzard BG. Adherence to combination antiretroviral therapy assessed by anonymous patient self-report. AIDS. 1998 Dec 3;12(17):2361-3. No abstract available.
- BackgroundRollnick S, Miller WR, Butler C. Motivational interviewing in health care: helping patients change behavior. Guilford Press; 2008.
- Background: PubMed 20887400Shemesh E, Fine RN. Is calculating the standard deviation of tacrolimus blood levels the new gold standard for evaluating non-adherence to medications in transplant recipients? Pediatr Transplant. 2010 Dec;14(8):940-3. doi: 10.1111/j.1399-3046.2010.01396.x. Epub 2010 Oct 1.
- 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.
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 Praise Text Messages in people with Medication Adherence and Liver Transplant Disorder, run by Children's Hospital Los Angeles 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 4 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 23 Aug 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 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?
Self-Reported Medication Adherence (time frame: 9 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?
On the ClinicalTrials.gov record for NCT04995770, which also lists 3 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 Aug 2021.