Clinical trial NCT02371720: Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease
Official title: Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-26
Enrollment: 164
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this research study is to learn about ways to help children and adults with sickle cell disease who are taking the medication, hydroxyurea.

Detailed description: Sickle cell disease (SCD) is an inherited chronic multi-organ system disorder that affects approximately 100,000 individuals in the United States, mostly belonging to minority, under-served populations. SCD is associated with substantial morbidity, premature mortality, individual suffering, health care costs and loss of productivity. Hydroxyurea (HU) the only disease modifying therapy for SCD is efficacious in reducing complications such as pain crisis and acute chest syndrome and improving survival. It is however, vastly underutilized and poorly adhered to because of barriers at the health care system, provider, treatment, socioeconomic, and patient levels. The investigator's overarching hypothesis is that barriers to acceptance and adherence to HU are multi-factorial and that a structured set of interventions can lead to improved adherence to medication and patient centered outcomes.

Eligibility criteria: Inclusion Criteria:

* be \>2 years of age up to 65 years of age, inclusive
* have a diagnosis of SCD, with either βS/βS, βS/βC, βS/βD, βS/β0, βS/βO-Arab, or βS/β+ genotype
* prescribed Hydroxyurea for at least the 6 months prior to study entry
* have daily access to a smart phone, tablet, personal computer or other device capable of producing and transmitting videos over the internet
* be willing and able to record and transmit videos

Exclusion Criteria:

* patient or caregiver refuses to take Hydroxyurea as treatment for SCD
* diagnosis of significant psychiatric disorder of the subject that could seriously impede the ability to participate in the study
* an assessment by the investigator that the subject will not comply with the study procedures outlined in the study protocol
* patients receiving automatic home delivery of medications since medication possession ratio is reflective of the patient initiation the refill when they have exhausted the home supply of HU

Primary outcomes:
measure: Medication Possession Ratio (MPR)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Hemoglobin (Hb) levels
timeFrame: Baseline, 24 months
measure: Change in mean cell volume (MCV)
timeFrame: Baseline, 24 months
measure: Change in fetal hemoglobin (HbF) levels
timeFrame: Baseline, 24 months
measure: Impact of adherence on clinical outcomes and healthcare utilization
timeFrame: Baseline, 24 months
measure: Impact of adherence on patients' lives
timeFrame: Baseline, 24 months
measure: Change in adherence with using Mobile-DOT
timeFrame: Baseline, 24 months
measure: Acceptability of intervention and of Hydroxyurea
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Emory University/Children's Healthcare of Atlanta
name: Lakshmanan Krishnamurti, MD
role: STUDY_CHAIR
References: