Medication AdherenceNCT04288271
Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3
A study testing Adherence Intervention and Healthy living education intervention in people with Medication Adherence and Kidney Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.
Trial summary
Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Medication Adherence, Kidney Transplantation
- What is being tested?
- Adherence Intervention and Healthy living education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 4 Feb 2022to 30 Jun 2023
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Patient Inclusion Criteria
- kidney-only transplant recipients, who are ≥3 months post-transplant
- Aged 12 to 24 years
- Patients followed at one of the study sites
Patient Exclusion Criteria
- Patients with significant neurocognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents and the healthcare team)
- Patients unable to communicate in English or French (Montreal sites only)
- Multi-organ transplant recipients
- Patient has a sibling participating in Stage 3
- Patients with no internet access
Parents Inclusion Criteria • Parent of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center) will be eligible
Parents Exclusion Criteria
- Parents of patients 18-24 years old will be excluded as the older aged group is expected to be primarily responsible for their own care, independent of their parents. One parent per family will be eligible to avoid redundant representation.
Health Care Professionals Inclusion Criteria
- Representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center.
- HCP from adherence intervention sites
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Temple University
Philadelphia, Pennsylvania, 19140-5102
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2536
Seattle Children's Hospital
Seattle, Washington, 98105-3901
St-Louis Children's Hospital
St Louis, Missouri, 63110-1002
Canada4 sites
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
CHU Ste-Justine
Montreal, Quebec, H3T 1C4
University of Toronto Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: TAKE-IT TOO: Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes
Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.
Read the detailed description
This entry describes Stage 3 of the study. In Stage 3, the adapted intervention and new e-pillbox and adherence-tracking website will be piloted in preparation for a definitive cluster-randomized trial (CRT). This study builds on the lessons from TAKE-IT and is a critical step towards a scalable intervention for real-world use.
Stage 3 aims to pilot the adapted intervention, including the new e-pillbox, in a CRT to:
- Determine the feasibility of a full-scale CRT (process considerations, attrition)
- Understand all stakeholders' experience with the intervention, including the degree to which the e-pillbox and adherence-tracking website are integrated into daily life by patients and into practice by HCP
- Estimate intra-cluster correlation coefficients (ICC) and other statistical parameters related to adherence outcomes relevant for sample size planning for a CRT. Adherence outcomes to be considered include daily proportion of patients with 100% taking adherence (defined as having taken all prescribed doses in a day) and daily proportion of patients with correct dosing (defined as having taken all prescribed doses within 2 hours before or after the scheduled time).
The adapted adherence-promoting intervention will be compared with another intervention in a pilot parallel-groups CRT. The interventions will be applied over 10 weeks. Participating centers, rather than patients, were randomized using a restricted randomization strategy with the Montreal Children's Hospital (MCH) assigned to the adherence intervention. This is necessary to ensure that the PI and lead site get sufficient experience with the intervention to guide other sites and to prepare for the full-scale CRT. All other sites were randomized, stratified on center size, to the new adherence intervention or the healthy living education intervention (control arm); this ensured adequate numbers of participants in each arm.
The aim is to enroll 67 patients across all sites over a 6-month interval. Based on numbers of available patients at each site, the targets noted above represent 13-50% of eligible patients at a given site. Allowing for 10% drop-out, 60 will complete the study (TAKE-IT had 4% drop-out by 6 mo.). Parents of eligible patients <18y old who have agreed to participate in the study will also be eligible to participate (57 parents anticipated). We will also enroll 2-3 HCPs, most involved with direct patient care, at each adherence intervention site to allow capture of information on their experience with the e-pillbox system and intervention over the course of the study (9 HCPs anticipated). No HCP will be enrolled at healthy living intervention sites. Participants will be blinded to group allocation but, given the nature of the intervention, coaches must be aware of group allocation.
Patients participants: Enrollment will be followed by a 4-week run-in period during which adherence will be monitored electronically, but no intervention will be applied. This will give participants time to become familiar with the e-pillbox and provide pre-intervention adherence data. All participants will receive a text message from study staff 1 week after initiation of the run-in to check-in on how they are doing with the e-pillbox. If a participant is experiencing difficulties, staff will offer assistance by phone. The first intervention will occur at 4 weeks (+/- 1 wk.). At this visit, participants will meet via video conferencing (or in person, if possible) with the coach. Participants at adherence intervention sites will begin the adherence-promoting intervention, including activation of dose reminders from the e-pillbox (as desired) and access to the adherence-tracking website. Participants at healthy living education intervention sites will begin the healthy living intervention, but will have no dose reminders from the e-pillbox and will not have access to the adherence-tracking website. The healthcare team will provide the usual level of care to all participants. Participants will have virtual (or phone) contact with coaches at increasing intervals between initiation of the intervention at week 4 and exit at week 14. The first check-in will occur at week 6 (+/- 1 wk), 2 weeks after initiation of the adherence-promoting intervention, the second will occur at week 10 (+/- 1 wk). This will allow intervals of increasing frequency between contacts as participants become more comfortable with procedures.
Parent participants: Parents of patient participants under 18 will be invited to participate in the study and accompany their child to study visits. Participating parents will be present at the beginning of the baseline visit to help their child provide demographic information. The parent will return at the end of the baseline visit, to learn how to use the e-pillbox (along with their child), to watch the educational videos and to respond to the PMBS and C-ATR. Parent participants will respond to the PMBS and C-ATR once more at week 14. Participating parents at adherence intervention sites will be present in the formation of the patient's action plan and choose their own action plan to support their child's adherence or independence. Parental participation throughout the study is encouraged but not mandatory.
HCP Participants: HCP-participants at adherence intervention sites will be trained to use the adherence-tracking website within 2 weeks before to 1 week after the first patient at their site completes the 4-week visit. HCP participants will be given access to the adherence data of all patient participants at their coaching site and invited to consult the website as often as they wish. HCP participants will also be shown a short (5 min) video providing education on assessing and supporting adherence.
HCP participants at adherence intervention sites will be advised that they will be informed by study staff about adherence events among participants in the interval between 4 and 14 weeks. When coaches review each participant's adherence on the portal during study visits, they will discuss non-adherence events with patients to determine if these were related to technical issues or real adherence issues. Within 1 week of study visits, the coach will provide the HCP with a copy of the patient's adherence calendar with a note as to whether the events seem to reflect real non-adherence. HCP will be advised that they will be under no obligation to act on this information, but may if they wish; if the participating HCP receiving information about a patient is not that patient's primary transplant care provider, they will be asked to transmit the information to the appropriate HCP on the patient's care team. Study staff will be provided with a suggested algorithm to follow if they receive such an alert.Within 2 weeks after the last patient at the site completes the 14-week visit at adherence intervention sites, HCP participants will complete questionnaires on their experience using the adherence-tracking web portal.
- Conditions
- Medication Adherence, Kidney Transplantation
- Being tested
- Adherence Intervention, Healthy living education intervention
- Keywords
- pediatric, adolescent, renal, allograft, immunosuppressive, immunosuppression, adherence, medication, young adult, mobile health, compliance, randomized trial, electronic pillbox
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence InterventionBehavioural
Also called Action-focused problem-solving, Electronic multi-dose pillbox monitoring system, Medy Box, Portable e-pillbox
Intervention:
- Adherence Support Team (patient, parent or a significant other, Coach)
- Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
- Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility
- 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient
Device:
- Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website
- Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week.
Healthy living education interventionOther
Intervention:
- Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
- Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits
- 'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient
Device:
- Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w)
| Study group | Role | What they receive |
|---|---|---|
| Adherence Intervention | Experimental | The objective of the intervention is to improve medication adherence. Patient-participants will use a multi-dose electronic pillbox and adherence tracking website which can provide dose reminders. Patient will form an Adherence Support Team (AST) including the participant, a parent (or other) and the "Coach" (study coordinator). The Coach will guide the AST to use Action-focused Problem-solving to address personal barriers to adherence. They will then generate concrete "if-then" plans for how they will behave in a given situation. Intervention participants with excellent adherence will be encouraged to work on building autonomy in medication-taking instead of adherence. Action plans will be able to be modified, if desired, at the 6-week and 10-week check-ins.
HCP-participants at intervention sites will be given the option to login to the adherence tracking website to view the adherence data of their patients. They will also be alerted by study staff to critical non-adherence events. Receives: Behavioral: Adherence Intervention |
| Healthy Living Education Intervention | Other | Patient-participants will receive a healthy living education intervention with the use of an e-pillbox. Contacts with the coach will occur at the same intervals as at adherence intervention sites. Participants will choose one of 3 healthy living topics on which they will receive education in an interactive format. The coach will engage the participant in a semi-scripted conversation on the selected topic. At check-ins, the coach will either continue the conversation on the topic selected at the outset or provide education on another topic. The coach will NOT engage in discussions about adherence and will NOT provide feedback on adherence data. Receives: Other: Healthy living education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taking Adherence
percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize adherence for each arm, the total percentage of days of observation for which there was 100% taking adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which taking adherence was 100% summed across all participants.
Measured: 14 weeks
Timing Adherence
percentage of doses taken within 2 hours before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize timing adherence for each arm, the total percentage of days of observation for which there is 100% timing adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which timing adherence is 100% summed across all participants.
Measured: 14 weeks
Secondary outcomes (2)
Self-reported Taking Adherence
Self-reported taking adherence will be assessed using the Basel Assessment of Adherence to Immunosuppressive Medications (BAASIS). Participants who report any missed doses in the prior 4 weeks will be classified as non-adherent; those missing no doses will be classified as adherent. Participants will also report the proportion of prescribed doses taken in the past 4 weeks (0-100%); a higher proportion indicates better taking adherence.
Measured: 14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)
Self-reported Timing Adherence
Self-reported timing adherence will be assessed using the Basel Assessment of Adherence to Immunosuppressive Medications (BAASIS). Participants who report any late or missed doses in the prior 4 weeks will be classified as non-adherent; those with no late or missing doses will be classified as adherent. Participants will also report the proportion of prescribed doses taken on schedule in the past 4 weeks (0-100%); a higher proportion indicates better taking adherence.
Measured: 14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start4 Feb 2022
- Primary completion19 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethany Foster, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bethany J Foster, MD, MSCE, Principal investigator, Montreal Children's Hospital of the MUHCAnnette DeVito Dabbs, PhD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288271
- Sponsor's protocol ID
- MP-CUSM-15-598
- Other IDs
- 5R01DK110737
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated will be available for use to other investigators in the research community. Data may be used for hypothesis testing, and to generate preliminary data in support of future research projects. A Data Sharing Committee, composed site investigators will review requests submitted for use of the data. If the request is approved, the appropriate data analysis will be performed and the results sent to the requesting investigator. Alternatively, depending on the request, it may be more appropriate to provide the requesting investigator with certain segments of the data. If this is the case, a file of the requested data (de-identified) will be provided to the investigator
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAKE-IT TOO: Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes
- ClinicalTrials.gov ID
- NCT04288271
- Acronym / sponsor ID
- MP-CUSM-15-598
- Conditions
- Medication Adherence, Kidney Transplantation
- Keywords
- pediatric, adolescent, renal, allograft, immunosuppressive, immunosuppression, adherence, medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Feb 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.
Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.
Detailed description
This entry describes Stage 3 of the study. In Stage 3, the adapted intervention and new e-pillbox and adherence-tracking website will be piloted in preparation for a definitive cluster-randomized trial (CRT). This study builds on the lessons from TAKE-IT and is a critical step towards a scalable intervention for real-world use.
Stage 3 aims to pilot the adapted intervention, including the new e-pillbox, in a CRT to:
- Determine the feasibility of a full-scale CRT (process considerations, attrition)
- Understand all stakeholders' experience with the intervention, including the degree to which the e-pillbox and adherence-tracking website are integrated into daily life by patients and into practice by HCP
- Estimate intra-cluster correlation coefficients (ICC) and other statistical parameters related to adherence outcomes relevant for sample size planning for a CRT. Adherence outcomes to be considered include daily proportion of patients with 100% taking adherence (defined as having taken all prescribed doses in a day) and daily proportion of patients with correct dosing (defined as having taken all prescribed doses within 2 hours before or after the scheduled time).
The adapted adherence-promoting intervention will be compared with another intervention in a pilot parallel-groups CRT. The interventions will be applied over 10 weeks. Participating centers, rather than patients, were randomized using a restricted randomization strategy with the Montreal Children's Hospital (MCH) assigned to the adherence intervention. This is necessary to ensure that the PI and lead site get sufficient experience with the intervention to guide other sites and to prepare for the full-scale CRT. All other sites were randomized, stratified on center size, to the new adherence intervention or the healthy living education intervention (control arm); this ensured adequate numbers of participants in each arm.
The aim is to enroll 67 patients across all sites over a 6-month interval. Based on numbers of available patients at each site, the targets noted above represent 13-50% of eligible patients at a given site. Allowing for 10% drop-out, 60 will complete the study (TAKE-IT had 4% drop-out by 6 mo.). Parents of eligible patients <18y old who have agreed to participate in the study will also be eligible to participate (57 parents anticipated). We will also enroll 2-3 HCPs, most involved with direct patient care, at each adherence intervention site to allow capture of information on their experience with the e-pillbox system and intervention over the course of the study (9 HCPs anticipated). No HCP will be enrolled at healthy living intervention sites. Participants will be blinded to group allocation but, given the nature of the intervention, coaches must be aware of group allocation.
Patients participants: Enrollment will be followed by a 4-week run-in period during which adherence will be monitored electronically, but no intervention will be applied. This will give participants time to become familiar with the e-pillbox and provide pre-intervention adherence data. All participants will receive a text message from study staff 1 week after initiation of the run-in to check-in on how they are doing with the e-pillbox. If a participant is experiencing difficulties, staff will offer assistance by phone. The first intervention will occur at 4 weeks (+/- 1 wk.). At this visit, participants will meet via video conferencing (or in person, if possible) with the coach. Participants at adherence intervention sites will begin the adherence-promoting intervention, including activation of dose reminders from the e-pillbox (as desired) and access to the adherence-tracking website. Participants at healthy living education intervention sites will begin the healthy living intervention, but will have no dose reminders from the e-pillbox and will not have access to the adherence-tracking website. The healthcare team will provide the usual level of care to all participants. Participants will have virtual (or phone) contact with coaches at increasing intervals between initiation of the intervention at week 4 and exit at week 14. The first check-in will occur at week 6 (+/- 1 wk), 2 weeks after initiation of the adherence-promoting intervention, the second will occur at week 10 (+/- 1 wk). This will allow intervals of increasing frequency between contacts as participants become more comfortable with procedures.
Parent participants: Parents of patient participants under 18 will be invited to participate in the study and accompany their child to study visits. Participating parents will be present at the beginning of the baseline visit to help their child provide demographic information. The parent will return at the end of the baseline visit, to learn how to use the e-pillbox (along with their child), to watch the educational videos and to respond to the PMBS and C-ATR. Parent participants will respond to the PMBS and C-ATR once more at week 14. Participating parents at adherence intervention sites will be present in the formation of the patient's action plan and choose their own action plan to support their child's adherence or independence. Parental participation throughout the study is encouraged but not mandatory.
HCP Participants: HCP-participants at adherence intervention sites will be trained to use the adherence-tracking website within 2 weeks before to 1 week after the first patient at their site completes the 4-week visit. HCP participants will be given access to the adherence data of all patient participants at their coaching site and invited to consult the website as often as they wish. HCP participants will also be shown a short (5 min) video providing education on assessing and supporting adherence.
HCP participants at adherence intervention sites will be advised that they will be informed by study staff about adherence events among participants in the interval between 4 and 14 weeks. When coaches review each participant's adherence on the portal during study visits, they will discuss non-adherence events with patients to determine if these were related to technical issues or real adherence issues. Within 1 week of study visits, the coach will provide the HCP with a copy of the patient's adherence calendar with a note as to whether the events seem to reflect real non-adherence. HCP will be advised that they will be under no obligation to act on this information, but may if they wish; if the participating HCP receiving information about a patient is not that patient's primary transplant care provider, they will be asked to transmit the information to the appropriate HCP on the patient's care team. Study staff will be provided with a suggested algorithm to follow if they receive such an alert.Within 2 weeks after the last patient at the site completes the 14-week visit at adherence intervention sites, HCP participants will complete questionnaires on their experience using the adherence-tracking web portal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence Intervention | Experimental | Behavioral: Adherence InterventionThe objective of the intervention is to improve medication adherence. Patient-participants will use a multi-dose electronic pillbox and adherence tracking website which can provide dose reminders. Patient will form an Adherence Support Team (AST) including the participant, a parent (or other) and the "Coach" (study coordinator). The Coach will guide the AST to use Action-focused Problem-solving to address personal barriers to adherence. They will then generate concrete "if-then" plans for how they will behave in a given situation. Intervention participants with excellent adherence will be encouraged to work on building autonomy in medication-taking instead of adherence. Action plans will be able to be modified, if desired, at the 6-week and 10-week check-ins. HCP-participants at intervention sites will be given the option to login to the adherence tracking website to view the adherence data of their patients. They will also be alerted by study staff to critical non-adherence events. |
| Healthy Living Education Intervention | Other | Other: Healthy living education interventionPatient-participants will receive a healthy living education intervention with the use of an e-pillbox. Contacts with the coach will occur at the same intervals as at adherence intervention sites. Participants will choose one of 3 healthy living topics on which they will receive education in an interactive format. The coach will engage the participant in a semi-scripted conversation on the selected topic. At check-ins, the coach will either continue the conversation on the topic selected at the outset or provide education on another topic. The coach will NOT engage in discussions about adherence and will NOT provide feedback on adherence data. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Adherence InterventionAlso: Action-focused problem-solving, Electronic multi-dose pillbox monitoring system, Medy Box, Portable e-pillboxIntervention: * Adherence Support Team (patient, parent or a significant other, Coach) * Standardized educational videos on immunosuppressive medications, rejection, and improving adherence * Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility * 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient Device: * Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website * Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week. | Behavioural | Adherence Intervention |
| Healthy living education interventionIntervention: * Standardized educational videos on immunosuppressive medications, rejection, and improving adherence * Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits * 'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient Device: • Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w) | Other | Healthy Living Education Intervention |
Primary outcome
Taking Adherence
Time frame: 14 weeks
percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize adherence for each arm, the total percentage of days of observation for which there was 100% taking adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which taking adherence was 100% summed across all participants.
Timing Adherence
Time frame: 14 weeks
percentage of doses taken within 2 hours before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize timing adherence for each arm, the total percentage of days of observation for which there is 100% timing adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which timing adherence is 100% summed across all participants.
2 secondary outcomes
Self-reported Taking Adherence
Time frame: 14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)
Self-reported Timing Adherence
Time frame: 14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits)
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 15 Mar 2024.
- Individual participant dataSharing planned: Yes. Data generated will be available for use to other investigators in the research community. Data may be used for hypothesis testing, and to generate preliminary data in support of future research projects. A Data Sharing Committee, composed site investigators will review requests submitted for use of the data. If the request is approved, the appropriate data analysis will be performed and the results sent to the requesting investigator. Alternatively, depending on the request, it may be more appropriate to provide the requesting investigator with certain segments of the data. If this is the case, a file of the requested data (de-identified) will be provided to the investigator
Related trials for Medication Adherence
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Not yet recruiting
A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial
Medication Adherence, Glycemic Control for Diabetes Mellitus
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
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.
Bethany J Foster, MD, MSCE principal investigator
Montreal Children's Hospital of the MUHC
Annette DeVito Dabbs, PhD principal investigator
University of Pittsburgh Medical Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence Intervention and Healthy living education intervention in people with Medication Adherence and Kidney Transplantation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. 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?
Taking Adherence (time frame: 14 weeks). 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 15 Mar 2024.