Medication Adherence in Youth With Sickle Cell Disease (SCD)

NCT02143076 | Completed

• 1 other identifier: WISEP
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage SCD. Electronic adherence monitoring is widely considered the gold standard in objective adherence measurement. These monitors provide continuous, real-time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays" (i.e. where individuals do not take medications for a specified interval of time), and "white coat" adherence (i.e., a pattern of drug adherence as a function of time where individuals display good adherence immediately before and after clinic attendance with worsening adherence in the period between). Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. Currently, only one electronic measure capable of monitoring medications in both pill and liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its validity and reliability, preliminary data support the use of Wise technology to measure adherence to medication. The current study will determine the Wise device's ability to feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD population.

Conditions

Sickle Cell Disease

Keywords

Medication Adherence; Hydroxyurea

Outcome Measures

Primary Outcomes (4)

• Percent Rate of Consent to Study Participation

  Of the total number of eligible participants, the percent of participants who agree to participate.

  Baseline

• Percent Rate of Device Use

  The percent of the total participants who keep medicine in the device during the entire trial period.

  Two months after baseline

• Percent Rate of Device Failure

  Percent of devices that failed defined as a device does not register opening as verified by study staff at the time device is returned to the study team.

  Two months after baseline

• Acceptability of Using the Wise Device

  Responses by participants and/or caregivers to the Acceptability Questionnaire based on the Likert scale from strongly disagree to strongly agree.

  Two months after baseline

Secondary Outcomes (1)

• Medication Adherence as Measured by Wise Device Compared to Other Measures of Medication Adherence

  Two months after baseline

Study Arms (1)

Sickle Cell Disease

Participants will complete three questionnaires during the course of the study: Demographic Questionnaire, Medical Adherence Measure Questionnaire, and Acceptability Questionnaire. All questionnaires will be completed in a private clinic room.

Behavioral: Demographic Questionnaire; Behavioral: Medical Adherence Measure Questionnaire; Behavioral: Acceptability Questionnaire

Interventions

Demographic Questionnaire BEHAVIORAL

At study enrollment, participants will complete a questionnaire to collect demographic information about the participant's family background, education and living situation.

Sickle Cell Disease

Medical Adherence Measure Questionnaire BEHAVIORAL

At the two-month follow-up visit, participants will be asked to complete a questionnaire describing all medications prescribed for them, when they take their medications, how much medication they take each time, how many times during the week they missed taking or were late taking each medication, reasons why they missed or were late, and how they manage their medications. In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

Sickle Cell Disease

Acceptability Questionnaire BEHAVIORAL

At the two-month follow-up visit, participants will be asked to complete a questionnaire about their perceptions of using the Wise electronic medication container. In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

Sickle Cell Disease

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will have a diagnosis of sickle cell disease,be receiving treatment with hydroxyurea, and meet eligibility criteria.

You may qualify if:

• Confirmed diagnosis of SCD (any genotype).
• Less than 18 years of age at time of study entry.
• Currently followed in the St. Jude Children's Research Hospital (SJCRH) SCD clinic.
• Stable HU dose prescribed (in pill or liquid formulation) for ≥ 6 months without documented hematological toxicity (excluding dose adjustments for weight gain).
• Lives with their primary caregiver.
• Anticipated to return to clinic at proposed 4-week or 8-week intervals.

You may not qualify if:

• Primary caregiver and/or youth unable to understand English and/or youth not cognitively intact (known IQ \< 70) such that the study questionnaire cannot be understood and completed.
• Any condition or chronic illness that in the opinion of the PI or Co-I makes participation on the study ill-advised.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Anemia, Sickle Cell; Medication Adherence

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lisa Ingerski, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

• Jerlym Porter, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)