Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

— SCD Mobile Dot  

Official title:

Patient Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy With Hydroxyurea in Patients With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371720
• Other study ID #: IRB00074105
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

Inclusion Criteria:

• be >2 years of age up to 65 years of age, inclusive

• have a diagnosis of SCD, with either ßS/ßS, ßS/ßC, ßS/ßD, ßS/ß0, ßS/ßO-Arab, or ßS/ß+ 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Mobile DOT
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Possession Ratio (MPR)	Proportion of days the patient is in possession of the medication in the study period	12 months
Secondary	Change in Hemoglobin (Hb) levels	Change in hemoglobin levels from baseline to 24 months will be measured using the HemoCue® rapid test.	Baseline, 24 months
Secondary	Change in mean cell volume (MCV)	Change from baseline in MCV will be calculated as the value at 24 months minus the value at baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the red blood cell (RBC) count in millions per microliter of blood, then multiplying by 10.	Baseline, 24 months
Secondary	Change in fetal hemoglobin (HbF) levels	Change from baseline in HbF will be calculated as the value at 24 months minus the value at baseline. HbF is expressed as a percentage.	Baseline, 24 months
Secondary	Impact of adherence on clinical outcomes and healthcare utilization	Health care utilization in the emergency department and hospitalization due to sickle cell related complications such as vaso-occlusive crisis (VOC) or acute chest syndrome (ACS). Retrospective chart review at baseline will be conducted to determine healthcare utilization.	Baseline, 24 months
Secondary	Impact of adherence on patients' lives	Impact of adherence on patients' lives measured using patient reported outcomes (PROMIS), surveys of school attendance, work absenteeism, out-of-pocket costs incurred by patients and their caregivers	Baseline, 24 months
Secondary	Change in adherence with using Mobile-DOT	Retrospective chart review at baseline will be conducted to determine medication possession rate (MPR) and then compared to the MPR at 24 months.	Baseline, 24 months
Secondary	Acceptability of intervention and of Hydroxyurea	Acceptability will be measured by Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness, Side Effects, Convenience, and Global Satisfaction, and it utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Scores range from 0-100, with 0 as extremely dissatisfied and 100 as extremely satisfied.	Baseline, 24 months