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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02578017 |
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Date of registration:
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23/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ElectroNic Hydroxyurea AdhereNCE: A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease
ENHANCE |
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Scientific title:
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ENHANCE Study (ElectroNic Hydroxyurea AdhereNCE): A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02578017 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Susan Creary, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nationwide Children's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
19 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sickle Cell Disease
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Intervention(s)
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Behavioral: Mobile DOT
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Primary Outcome(s)
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Achievement of =80% HU adherence
[Time Frame: 12 months]
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Secondary Outcome(s)
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Changes in self-managment skills
[Time Frame: 12 months]
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Correlation of video observation adherence with other measures of adherence.
[Time Frame: 12 months]
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Secondary ID(s)
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NCH14-00163
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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