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ElectroNic Hydroxyurea AdhereNCE: A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease (ENHANCE)

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ClinicalTrials.gov Identifier: NCT02578017
Recruitment Status : Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Creary, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Mobile DOT Not Applicable

Detailed Description:

This is a 12-month, single-arm, cross-over study for pediatric and adolescent patients with SCD who are prescribed HU at Nationwide Children's Hospital in order to compare HU adherence prior to the study, during Mobile Dot use and after using Mobile DOT.

Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell disease (SCD). Multiple clinical trials show that HU can reduce SCD-related complications but only 50% of pediatric patients adhere to HU at the rates achieved in clinical trials. This poor adherence limits its clinical effectiveness and results in increased costs and in lower patient-reported quality of life.

An innovative, practical, inexpensive, and efficient strategy is needed to improve HU adherence in pediatric patients with SCD. Electronic directly observed therapy (Mobile DOT) is a pilot-tested, multi-dimensional tool that is a feasible and acceptable strategy and can achieve >90% HU adherence rates in a small cohort of pediatric patients with SCD. This study will provide further testing to confirm if Mobile DOT can improve adherence and improve clinical outcomes in patients with SCD.

Mobile DOT uses patients' smart phones and computers to provide electronic reminder alerts and to video-record patients' daily HU administrations. Patients are provided with text (SMS) messages, e-mails, and phone call communications to encourage adherence and they receive monetary incentives when they reach adherence goals.

Researchers will determine if video adherence correlates with self-report, biomarker, and refill adherence. Also, surveys will be completed by participants to determine if their self-management skills improve with Mobile DOT.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ENHANCE Study (ElectroNic Hydroxyurea AdhereNCE): A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

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

No Intervention: Post-intervention observation
All participants will not receive any additional adherenece intervention after completing the Mobile DOT arm. Participants will be observed for 6 months.



Primary Outcome Measures :
  1. Achievement of ≥80% HU adherence [ Time Frame: 12 months ]
    Compare the number of participants who achieve ≥80% HU adherence when patients receive Mobile DOT to the 6 months prior to study entry.


Secondary Outcome Measures :
  1. Correlation of video observation adherence with other measures of adherence. [ Time Frame: 12 months ]
    Determine if video observation adherence correlations with biomarker adherence (MCV, HbF, and urine assay), self-report, and refill estimated adherence.

  2. Changes in self-managment skills [ Time Frame: 12 months ]
    To explore adolescent and young adults' self-managment skills using the transition readiness questionnaire before and after mobile DOT.



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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Current chronic transfusion therapy or apheresis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578017


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Susan Creary, MD Nationwide Children's Hospital

Responsible Party: Susan Creary, Assistant Professor of Pediatric Hematology/Oncology, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02578017     History of Changes
Other Study ID Numbers: NCH14-00163
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Susan Creary, Nationwide Children's Hospital:
Sickle Cell Disease
Hydroxyurea
Adherence

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors