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Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth

2019년 12월 10일 업데이트: St. Jude Children's Research Hospital

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).

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

100

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Tennessee
      • Memphis, Tennessee, 미국, 38105
        • St. Jude Children's Research Hospital
      • Memphis, Tennessee, 미국, 38120
        • Baptist Memorial Hospital, Baptist Clinical Research Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

15년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Participants will reside in the Memphis, Tennessee, area and meet the inclusion criteria.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Compare the number of patients with hydroxyurea barriers or facilitators in hydroxyurea maintenance users and hydroxyurea former users/non-users (Phase I)
기간: 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.
From on-study date up to 12 months later
Number of participants who are enrolled and randomized on the study (Phase II)
기간: 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.
From study start date through up to 24 months later
Number of randomized patients completing baseline and 24-week evaluations for both arms
기간: 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.
From on-study date up to 24 weeks later
Compare the number of participants who report themHealth intervention is useful
기간: 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.
Weeks 12 and 24
The mean and standard deviation of change in satisfaction with mHealth intervention
기간: 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.
From on-study date up to 24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

St. Jude Children's Research Hospital

협력자

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

수사관

  • 수석 연구원: Jane S. Hankins, MD, MS, St. Jude Children's Research Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 12월 5일

기본 완료 (실제)

2018년 6월 28일

연구 완료 (실제)

2018년 6월 28일

연구 등록 날짜

최초 제출

2017년 11월 6일

QC 기준을 충족하는 최초 제출

2017년 11월 13일

처음 게시됨 (실제)

2017년 11월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 12월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 12월 10일

마지막으로 확인됨

2019년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • REHASH
  • U01HL133996 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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