Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth

Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth

Sponsors

Lead Sponsor: St. Jude Children's Research Hospital

Collaborator: University of Memphis
National Heart, Lung, and Blood Institute (NHLBI)

Source St. Jude Children's Research Hospital
Brief Summary

National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend that hydroxyurea be offered to symptomatic adults and all children with sickle cell disease (SCD) (HbSS and HbSβ0-thal genotypes) age ≥9 months. Research has shown that hydroxyurea reduces hospitalizations and mortality, supporting its effectiveness outside of clinical trials. Hydroxyurea is given as a once-daily oral dose that costs <$1 per day. Despite overwhelming evidence for positive effects, hydroxyurea is vastly underutilized. Given the relative ease of its administration, low cost, and safety profile, barriers to hydroxyurea utilization are primarily constrained to the health system and patient determinants. System-level barriers include insufficient access to SCD-specific care, limited access to medication (due to lack of health coverage), and providers' reluctance in prescribing it; while patient-level barriers include low acceptance (due to insufficient knowledge or misconceptions regarding risks and benefits), and forgetfulness leading to poor adherence.

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

Data for the needs assessment and pilot trial will be collected from the patients via validated surveys, qualitative methods (e.g., interviews and focus groups), and medical record abstraction.

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.

Overall Status Completed
Start Date December 5, 2017
Completion Date June 28, 2018
Primary Completion Date June 28, 2018
Study Type Observational
Primary Outcome
Measure Time Frame
Compare the number of patients with hydroxyurea barriers or facilitators in hydroxyurea maintenance users and hydroxyurea former users/non-users (Phase I) From on-study date up to 12 months later
Number of participants who are enrolled and randomized on the study (Phase II) From study start date through up to 24 months later
Number of randomized patients completing baseline and 24-week evaluations for both arms From on-study date up to 24 weeks later
Compare the number of participants who report themHealth intervention is useful Weeks 12 and 24
The mean and standard deviation of change in satisfaction with mHealth intervention From on-study date up to 24 weeks
Enrollment 100
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Diagnosis of sickle cell disease (any genotype)

- Between the ages of 15 and 44.9 years

- English-speaking

Exclusion Criteria:

- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Gender: All

Minimum Age: 15 Years

Maximum Age: 44 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jane S. Hankins, MD, MS Principal Investigator St. Jude Children's Research Hospital
Location
Facility:
St. Jude Children's Research Hospital | Memphis, Tennessee, 38105, United States
Baptist Memorial Hospital, Baptist Clinical Research Institute | Memphis, Tennessee, 38120, United States
Location Countries

United States

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Phase I

Description: It is estimated that 100 participants with SCD will be enrolled for the Phase I portion which will identify barriers to hydroxyurea utilization.

Label: Phase II

Description: 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.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov