Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- Emory University
- Enrollment
- 164
- Locations
- 4
- Primary Endpoint
- Medication Possession Ratio (MPR)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Lakshmanan Krishnamurti
Professor
Emory University
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
Outcomes
Primary Outcomes
Medication Possession Ratio (MPR)
Time Frame: 12 months
Proportion of days the patient is in possession of the medication in the study period
Secondary Outcomes
- Change in mean cell volume (MCV)(Baseline, 24 months)
- Change in fetal hemoglobin (HbF) levels(Baseline, 24 months)
- Impact of adherence on clinical outcomes and healthcare utilization(Baseline, 24 months)
- Impact of adherence on patients' lives(Baseline, 24 months)
- Change in adherence with using Mobile-DOT(Baseline, 24 months)
- Change in Hemoglobin (Hb) levels(Baseline, 24 months)
- Acceptability of intervention and of Hydroxyurea(Baseline, 24 months)