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MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires, Interviews, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete. (CAREGIVER) V."
  • "To explore barriers and facilitators to adoption, feasibility, and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews. (CAREGIVER) VIII."
  • "To explore barriers and facilitators to adoption, feasibility, implementation, organizational/contextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews. (INSTITUTIONAL) OUTLINE: Participants are randomized to 1 of 2 groups."
  • "GROUP A: Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months."
  • "Patients also undergo blood sample collection throughout the study."
  • "GROUP B: Participants receive usual care consisting of medical consultations and supportive care for 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Parent of a child diagnosed with acute lymphoblastic leukemia (ALL) * Child patient age 365 days to \< 19 years at time of study entry. * Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube. * Verbal fluency in English, or Spanish * Parent has a smartphone or computer access with an Internet connection. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Parent is unwilling or unable to follow protocol requirements.

Study sites (1)

NY