Medication AdherenceTAKE-IT TOONCT02910661
Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
An observational study of Medication Adherence, run by Beth Foster at 9 sites in 2 countries.
Trial summary
The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Focus Group
- How many people
- 95 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 28 Mar 2017to 6 Aug 2017
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Representative groups of stakeholders (patients, parents and HCP) will be recruited from renal transplant centers representing two healthcare systems and a variety of program sizes: 3 in the United States (UPMC [which includes both adult and pediatric programs], Seattle Children's Hospital and St. Louis Children's Hospital), and 5 in Canada (MUHC, Ste-Justine Hospital (HSJ), Centre Hospitalier de l'Université de Montréal (CHUM), Vancouver's British Columbia Children's Hospital, and Toronto's Hospital for Sick Children).
Who may be able to join
- Patients: Prevalent kidney-only transplant recipients 12-24 y, ≥3 months post-transplant.
- Parents: Parents of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center). Parents will be eligible to participate even if their child does not participate.
- HCP: transplant healthcare professionals (including representatives from variety of disciplines typically involved in promoting medication adherence)
Who cannot join
- Patients: Individuals with significant neurocognitive disabilities limiting their ability to understand and participate in their own care. Multiorgan transplant recipients. Patient or parent unable to communicate in English or French (Montreal only)
- Parents: Parents of patients 18-24 years old will be excluded
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Canada5 sites
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T7
CHU Ste-Justine
Montreal, Quebec, H3T 1C4
Montreal Children's Hospital of the MUHC
Montreal, Quebec, H4A 3J1
University of Toronto Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
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
Children's Hospital St-Louis
St Louis, Missouri, 63110-1002
About this study
Official title: TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.
Read the detailed description
TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus groups (FG) to gather data about the needs and preferences of stakeholders to inform adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The protocols for Stages 2 and 3 will be submitted separately.
- Conditions
- Medication Adherence
- Being tested
- Focus Group
- Keywords
- Kidney Transplantation
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Concurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last ~90 min. and be audio-recorded. An observer will take field notes.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Focus groups (n=6-8/group) will be conducted at 4 sites selected to maximize racial diversity and to ensure availability of adequate numbers in each age group (Montreal (incl. the McGill University Health Centre (MUHC), Centre Hospitalier Universitaire-Ste. Justine \& CHUM ), Pittsburgh, Seattle, and St. Louis). Separate focus groups will be conducted with patients clustered by patient age to maximize homogeneity in developmental stage. Purposive sampling will be employed to ensure that each focus group includes patients with combinations of characteristics that are likely to account for variation in perspectives, including the major racial and ethnic groups, both sexes, time since transplant, and level of adherence. Receives: Other: Focus Group | |
| Parents | Focus groups (n=6-8/group) will be conducted at Pittsburgh \& Seattle. Focus groups will be conducted with parents clustered by patient age (12-14 y. \& 15- 17 y.) Receives: Other: Focus Group | |
| Healthcare professionals | One focus group of healthcare professionals (HCP) representing the variety of multidisciplinary transplant team members at each center will be convened. We will aim for 4-8 HCP per group; however, the number will be dictated by the composition and size of the transplant team at each site. We expect variability in the organization of care across the 7 sites, which represent 2 countries and small to large program sizes; including all sites will capture this variability. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stakeholders' needs and preferences
needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start28 Mar 2017
- Primary completion6 Aug 2017
- Study completion6 Aug 2017
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Foster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, St. Louis Children's Hospital, Seattle Children's Hospital, St. Justine's Hospital, The Hospital for Sick Children, British Columbia Children's Hospital, Temple University, Université de Montréal
- Responsible party
- Sponsor-investigator, Beth Foster, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Bethany J Foster, MD, MSCE, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreAnnette DeVito Dabbs, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910661
- Sponsor's protocol ID
- 2017-1764
- Acronym
- TAKE-IT TOO
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2017. 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 (Stage 1)
- ClinicalTrials.gov ID
- NCT02910661
- Acronym / sponsor ID
- TAKE-IT TOO / 2017-1764
- Conditions
- Medication Adherence
- Keywords
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Beth FosterUniversity, hospital or other
- Collaborators
- University of Pittsburgh, St. Louis Children's Hospital, Seattle Children's Hospital, St. Justine's Hospital, The Hospital for Sick Children, British Columbia Children's Hospital, Temple University, Université de Montréal
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 6 Aug 2017 (actual)
- Study completion
- 6 Aug 2017 (actual)
- First posted
- 22 Sep 2016 (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.
The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.
Detailed description
TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus groups (FG) to gather data about the needs and preferences of stakeholders to inform adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The protocols for Stages 2 and 3 will be submitted separately.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Focus GroupFocus groups (n=6-8/group) will be conducted at 4 sites selected to maximize racial diversity and to ensure availability of adequate numbers in each age group (Montreal (incl. the McGill University Health Centre (MUHC), Centre Hospitalier Universitaire-Ste. Justine \& CHUM ), Pittsburgh, Seattle, and St. Louis). Separate focus groups will be conducted with patients clustered by patient age to maximize homogeneity in developmental stage. Purposive sampling will be employed to ensure that each focus group includes patients with combinations of characteristics that are likely to account for variation in perspectives, including the major racial and ethnic groups, both sexes, time since transplant, and level of adherence. |
| Parents | – | Other: Focus GroupFocus groups (n=6-8/group) will be conducted at Pittsburgh \& Seattle. Focus groups will be conducted with parents clustered by patient age (12-14 y. \& 15- 17 y.) |
| Healthcare professionals | – | Other: Focus GroupOne focus group of healthcare professionals (HCP) representing the variety of multidisciplinary transplant team members at each center will be convened. We will aim for 4-8 HCP per group; however, the number will be dictated by the composition and size of the transplant team at each site. We expect variability in the organization of care across the 7 sites, which represent 2 countries and small to large program sizes; including all sites will capture this variability. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Representative groups of stakeholders (patients, parents and HCP) will be recruited from renal transplant centers representing two healthcare systems and a variety of program sizes: 3 in the United States (UPMC [which includes both adult and pediatric programs], Seattle Children's Hospital and St. Louis Children's Hospital), and 5 in Canada (MUHC, Ste-Justine Hospital (HSJ), Centre Hospitalier de l'Université de Montréal (CHUM), Vancouver's British Columbia Children's Hospital, and Toronto's Hospital for Sick Children).
Key inclusion criteria (3 listed)
- Patients: Prevalent kidney-only transplant recipients 12-24 y, ≥3 months post-transplant.
- Parents: Parents of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center). Parents will be eligible to participate even if their child does not participate.
- HCP: transplant healthcare professionals (including representatives from variety of disciplines typically involved in promoting medication adherence)
Key exclusion criteria (2 listed)
- Patients: Individuals with significant neurocognitive disabilities limiting their ability to understand and participate in their own care. Multiorgan transplant recipients. Patient or parent unable to communicate in English or French (Montreal only)
- Parents: Parents of patients 18-24 years old will be excluded
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 |
|---|---|---|
| Focus GroupConcurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last ~90 min. and be audio-recorded. An observer will take field notes. | Other | Healthcare professionals, Parents, Patients |
Primary outcome
Stakeholders' needs and preferences
Time frame: 90 minutes
needs and preferences of young kidney transplant recipients, their parents, and HCP regarding electronic monitoring and adherence interventions
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 28 Sep 2017.
- 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.
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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.
Bethany J Foster, MD, MSCE principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Annette DeVito Dabbs, PhD principal investigator
University of Pittsburgh
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence, run by Beth Foster at 9 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?
The sponsor lists 3 inclusion and 2 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, 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?
Stakeholders' needs and preferences (time frame: 90 minutes). 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 28 Sep 2017.