Patient Centered Comprehensive Medication Adherence Management System in Patients With Sickle Cell Disease
SCD Mobile Dot
1 other identifier
interventional
164
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 5, 2021
March 1, 2021
4.6 years
February 19, 2015
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Medication Possession Ratio (MPR)
Proportion of days the patient is in possession of the medication in the study period
12 months
Secondary Outcomes (7)
Change in Hemoglobin (Hb) levels
Baseline, 24 months
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
- +2 more secondary outcomes
Study Arms (4)
Adults - Mobile DOT
EXPERIMENTALSubjects 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.
Adults - standard of care then Mobile DOT
ACTIVE COMPARATORSubjects 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.
Children - Mobile DOT
EXPERIMENTALSubjects 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.
Children - standard of care then Mobile DOT
ACTIVE COMPARATORSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (4)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60607, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lakshmanan Krishnamurti, MD
Emory University/Children's Healthcare of Atlanta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2015
First Posted
February 26, 2015
Study Start
June 1, 2014
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
March 5, 2021
Record last verified: 2021-03