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Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth

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ClinicalTrials.gov Identifier: NCT03344900
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : December 31, 2018
Sponsor:
Collaborators:
University of Memphis
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date November 6, 2017
First Posted Date November 17, 2017
Last Update Posted Date December 31, 2018
Actual Study Start Date December 5, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2017)
  • Compare the number of patients with hydroxyurea barriers or facilitators in hydroxyurea maintenance users and hydroxyurea former users/non-users (Phase I) [ Time Frame: From on-study date up to 12 months later ]
    Multi-level needs assessment of hydroxyurea utilization barriers and facilitators, in Memphis, Tennessee, will be conducted to identify potential factors that affect the barriers or facilitators of hydroxyurea acceptance and that affect the adherence/maintenance of hydroxyurea. Enrollment for Phase I is estimated to be 100. The numbers of patients with barriers or facilitators in hydroxyurea maintenance users and hydroxyurea former users/non-users will be provided and will be compared using Fisher's exact text. This will be done via questionnaires with individuals living with sickle cell disease.
  • Number of participants who are enrolled and randomized on the study (Phase II) [ Time Frame: From study start date through up to 24 months later ]
    In terms of feasibility of enrollment and randomization, that is, we will assess if we can enroll and randomize 40% (versus an unacceptable rate of 30%) of the approached eligible individuals (56 patients out of 150 approached) in the 24-month accrual duration.
  • Number of randomized patients completing baseline and 24-week evaluations for both arms [ Time Frame: From on-study date up to 24 weeks later ]
    In terms of the feasibility of conducting a randomized trial, that is, after randomization, per each arm, we will assess if we can have 75% (versus an unacceptable rate of 50%) of randomized individuals (19 patients out of 28 randomized per arm) will complete at least baseline and 24-week evaluations.
  • Compare the number of participants who report themHealth intervention is useful [ Time Frame: Weeks 12 and 24 ]
    Measure the patients' perceived usefulness of mHealth intervention as an aid to hydroxyurea adherence. The proportions of patients who reported the mHealth intervention is useful at weeks 12 and 24 will be provided and will be tested to see if it is significantly different from random at a significance level of 0.05.
  • The mean and standard deviation of change in satisfaction with mHealth intervention [ Time Frame: From on-study date up to 24 weeks ]
    Measure satisfaction of the intervention by comparing the change in satisfaction measured by the Treatment Satisfaction Questionnaire for Medication (TSQM-9) from baseline to 24 weeks. The change in satisfaction from baseline to 24 weeks will be summarized using mean and standard deviation in the text messaging arm and will be tested using t-test or Wilcoxon signed rank test depending on the normality of the data tested by Shapiro Wilk test at a significance level of 0.05.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03344900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth
Official Title Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants will reside in the Memphis, Tennessee, area and meet the inclusion criteria.
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2017)
172
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jane S. Hankins, MD, MS 866-278-5833 referralinfo@stjude.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03344900
Other Study ID Numbers REHASH
U01HL133996 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor St. Jude Children's Research Hospital
Collaborators
  • University of Memphis
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jane S. Hankins, MD, MS St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date December 2018