Overview

This trial is active, not recruiting.

Condition sickle cell disease
Treatment mobile dot
Sponsor Emory University
Collaborator Patient-Centered Outcomes Research Institute
Start date June 2014
End date December 2018
Trial size 160 participants
Trial identifier NCT02371720, IRB00074105

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Subjects with SCD that are older than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
mobile dot Comprehensive medication adherence management
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
(Active Comparator)
Subjects with SCD that are older than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
mobile dot Comprehensive medication adherence management
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
(Experimental)
Subjects with SCD that are younger than 21 years old will receive comprehensive medication adherence management (Mobile DOT) after 1 month assessment period. The subjects will receive the Mobile DOT intervention for 24 months.
mobile dot Comprehensive medication adherence management
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
(Active Comparator)
Subjects with SCD that are younger than 21 years old will receive standard of care for the first 12 months. They will then crossover to the comprehensive medication adherence management plan (Mobile DOT) after 1 month assessment period for the remaining 12 months.
mobile dot Comprehensive medication adherence management
Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.

Primary Outcomes

Measure
Medication Possession Ratio (MPR)
time frame: 12 months

Secondary Outcomes

Measure
Change in Hemoglobin (Hb) levels
time frame: Baseline, 24 months
Change in mean cell volume (MCV)
time frame: Baseline, 24 months
Change in fetal hemoglobin (HbF) levels
time frame: Baseline, 24 months
Impact of adherence on clinical outcomes and healthcare utilization
time frame: Baseline, 24 months
Impact of adherence on patients' lives
time frame: Baseline, 24 months
Change in adherence with using Mobile-DOT
time frame: Baseline, 24 months
Acceptability of intervention and of Hydroxyurea
time frame: Baseline, 24 months

Eligibility Criteria

Male or female participants from 2 years up to 65 years old.

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 Hydroxyurea. - 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. - Patient is on liquid form of Hydroxyurea since MPR - calculations are difficult. - 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.

Additional Information

Official title Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Emory University.