NCT02578017

Brief Summary

HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU can reduce SCD related symptoms, but only 50% of patients take it as often as they should. This limits how much HU can help reduce SCD symptoms. Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a program that uses cell phone reminder messages, videos, feedback messages, and incentives will help patients with SCD take HU as prescribed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

4.9 years

First QC Date

September 23, 2015

Last Update Submit

July 8, 2019

Conditions

Sickle Cell Disease

Keywords

Sickle Cell DiseaseHydroxyureaAdherence

Outcome Measures

Primary Outcomes (1)

  • Achievement of ≥80% HU adherence

    Compare the number of participants who achieve ≥80% HU adherence when patients receive Mobile DOT to the 6 months prior to study entry.

    12 months

Secondary Outcomes (2)

  • Correlation of video observation adherence with other measures of adherence.

    12 months

  • Changes in self-managment skills

    12 months

Study Arms (2)

Mobile DOT

EXPERIMENTAL

All Participants will utilize Mobile DOT for 6 months. The Mobile DOT intervention includes: reminder alerts, participant videos, research staff feedback on adherence, and contingency management.

Behavioral: Mobile DOT

Post-intervention observation

NO INTERVENTION

All participants will not receive any additional adherenece intervention after completing the Mobile DOT arm. Participants will be observed for 6 months.

Interventions

Mobile DOTBEHAVIORAL

Mobile DOT is a multi-dimensional tool that uses automated reminders, adherence feedback messages, incentives, and video observation of medication administration.

Mobile DOT

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Sickle Cell Disease (SCD), any genotype
  • Prescribed HU for at least the previous 6 months
  • Plans to receive SCD-related care at Nationwide Children's Hospital for the study duration
  • For participants ≥18 years: participant must have access to a smart-phone or computer capable of recording and submitting videos to Mobile DOT
  • For participants \<18 years: consenting adult must have access to a smart-phone or computer capable of recording and submitting videos to Mobile DOT AND agrees to enter into a mutual agreement to participate in the daily medication administration routine
  • Patient and/or consenting adult must speak English
  • Access to a working phone (smart phone or landline)

You may not qualify if:

  • Current chronic transfusion therapy or apheresis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • Creary S, Chisolm D, Stanek J, Neville K, Garg U, Hankins JS, O'Brien SH. Measuring hydroxyurea adherence by pharmacy and laboratory data compared with video observation in children with sickle cell disease. Pediatr Blood Cancer. 2020 Aug;67(8):e28250. doi: 10.1002/pbc.28250. Epub 2020 May 9.

    PMID: 32386106DERIVED

  • Creary S, Chisolm D, Stanek J, Hankins J, O'Brien SH. A Multidimensional Electronic Hydroxyurea Adherence Intervention for Children With Sickle Cell Disease: Single-Arm Before-After Study. JMIR Mhealth Uhealth. 2019 Aug 8;7(8):e13452. doi: 10.2196/13452.

    PMID: 31397291DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Susan Creary, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatric Hematology/Oncology

Study Record Dates

First Submitted

September 23, 2015

First Posted

October 16, 2015

Study Start

July 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

US(1)