Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease (SCD Mobile Dot)

Emory University

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Behavioral: Mobile DOT

Study type: Interventional

Funder types: Other

Identifiers

NCT02371720

IRB00074105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Ages: 2 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 4 patient groups

Adults - Mobile DOT

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile DOT

Adults - standard of care then Mobile DOT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mobile DOT

Children - Mobile DOT

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile DOT

Children - standard of care then Mobile DOT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mobile DOT