Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Hydroxyurea, Adherence
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.
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.
Interventions
BEHAVIORALMobile DOT
Mobile DOT is a multi-dimensional tool that uses automated reminders, adherence feedback messages, incentives, and video observation of medication administration.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of ≥80% HU adherence | 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation of video observation adherence with other measures of adherence. | 12 months | Determine if video observation adherence correlations with biomarker adherence (MCV, HbF, and urine assay), self-report, and refill estimated adherence. |
| Changes in self-managment skills | 12 months | To explore adolescent and young adults' self-managment skills using the transition readiness questionnaire before and after mobile DOT. |
Countries
United States
Outcome results
None listed