Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth
NCT ID: NCT03344900
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2017-12-05
2018-06-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Mobile health (mHealth) refers to the practice of medicine and public health supported by mobile devices. Short message service (SMS) text messaging (through cell phones) is a widespread means of communication, particularly among adolescents and young adults and is an emerging intervention modality to improve medication adherence. Its low cost, simplicity, and prevalence allow for relatively easy adoption and dissemination in medical practices.
This protocol seeks to examine barriers to hydroxyurea adherence among SCD patients between 15 and 45 years of age who are living in the Memphis region by conducting a needs assessment. In addition to examining these barriers, the needs assessment will provide data that will inform the development of an mHealth application (e.g. mobile phone application) for assisting patients in increasing their medication adherence. The developed mHealth intervention will then undergo a pilot trial to test its acceptability, satisfaction, and feasibility among 56 patients living with SCD.
* To conduct multi-level needs assessment of hydroxyurea utilization barriers and facilitators, in Memphis, Tennessee (Phase I).
* To test the feasibility and acceptance of a patient-informed smart phone application aimed at improving hydroxyurea adherence in the Memphis, Tennessee region, and to estimate the efficacy parameters needed to design a definitive large phase III trial (Phase II).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will utilize a Hybrid Effectiveness-Implementation design that will blend both a new intervention to impact the effectiveness of hydroxyurea, text messaging, and study its potential for adoption and dissemination in "real-world" practice settings. In Phase I (formative process evaluation), actionable barriers of hydroxyurea adherence in Memphis, Tennessee, will be identified. The investigators will begin by conducting a broad evaluation of hydroxyurea utilization, impediments and facilitators of hydroxyurea adherence and care management in general for patients with SCD. Next, this information will be merged with patients' preferences for the content of an mHealth intervention, and test it in a local cohort (Phase II). If successful and approved by the Sickle Cell Disease Implementation Consortium (SCDIC) executive committee, this intervention will advance to the next phase, namely, the dissemination and implementation in a larger geographical area (the other SCDIC participating sites in Phase III). We will utilize the RE-AIM framework to evaluate the intervention representativeness and impact during all phases.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase I
It is estimated that 100 participants with SCD will be enrolled for the Phase I portion which will identify barriers to hydroxyurea utilization.
No interventions assigned to this group
Phase II
It is estimated that 72 participants with SCD will be enrolled for the Phase II portion of the study which will evaluate the degree of feasibility and acceptance of mHealth intervention on hydroxyurea adherence.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Between the ages of 15 and 44.9 years
* English-speaking
Exclusion Criteria
15 Years
44 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Memphis
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jane S. Hankins, MD, MS
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Baptist Memorial Hospital, Baptist Clinical Research Institute
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
St. Jude Children's Research Hospital
ClinicalTrials Open at St. Jude
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REHASH
Identifier Type: -
Identifier Source: org_study_id