NCT02029742

Brief Summary

The investigators propose that culturally aligned community-based interventions in our multi-ethnic sickle cell disease (SCD) population, augmented by task-focused communication technology, can improve self-managed adherence to hydroxyurea (HU) by decreasing barriers to use, supporting parent-youth partnerships for chronic disease self-management and reinforcing the behavior of daily medication use. Culturally aligned community health workers (CHW) are a well-established means to support chronic disease self-management by underserved families, in partnership with medical homes. CHWs can identify and address multiple barriers and reinforce developmentally appropriate self-management to help youth reach and maintain their best fetal hemoglobin (HbF) levels. However, this strategy alone may be insufficient to achieve daily HU adherence. The investigators therefore propose a feasibility trial to test the feasibility and acceptability of a structured intervention of CHW support to address existing barriers to improve HU use, augmented by daily cue-based parent and youth text message reminders, to efficiently extend CHW family support and reinforce family partnerships for self-management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

January 6, 2014

Last Update Submit

May 3, 2024

Conditions

Sickle Cell Disease

Keywords

Sickle cell diseaseMedication adherenceHydroxyureaCommunity health worker interventionSickle Cell Treatment

Outcome Measures

Primary Outcomes (1)

  • Effect size of the intervention on hydroxyurea (HU) adherence

    In this feasibility study, feasibility will be assessed of our methods, the impact of the intervention on adherence to hydroxyurea, and the ability to retain subjects throughout the 6 month period. These data will be used to calculate the effect size of the intervention to estimate the sample needed for a larger trial.

    6 months

Secondary Outcomes (3)

  • Effect size of the intervention on youth-parent communication about self-management responsibility

    6 months

  • Effect size of the intervention on youth-parent communication about quality of life (QOL)

    6 months

  • Effect size of the intervention on youth-parent communication about resource use

    6 months

Study Arms (2)

Community Health Worker Intervention

EXPERIMENTAL

Community Health Workers will have scheduled interactions with subjects and will customize text messaging jointly with each youth and parent and initiate text message reminders to both parent and youth for months 4-6.

Behavioral: Community Health Worker (CHW)

Education

ACTIVE COMPARATOR

Those randomized to the Education group will continue usual care, and will be provided with educational materials about sickle cell disease and hydroxyurea use for children.

Behavioral: Education

Interventions

Community Health Worker (CHW)BEHAVIORAL

CHWs will have scheduled interactions with subjects at home, by telephone or at Community League of the Heights (CLOTH), our partner community-based organization (CBO). CHWs will customize text messaging jointly with each youth and parent (Month 3) and text message reminders to both parent and youth will be implemented during Months 4-6. Subjects lacking a mobile phone or sufficient cell phone plan will be compensated to purchase or upgrade plans to accommodate texts.

Community Health Worker Intervention
EducationBEHAVIORAL

Dyads randomized to the control group will continue usual clinic-based care, including monitoring and review of HbF levels, and similar frequency of clinic visits and access to sickle cell team staff. They will be provided with educational materials about sickle cell disease and hydroxyurea use for children.

Education

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youth:
  • Sickle type - homozygous sickle disease or sickle-beta thalassemia disease
  • Age 10 to 18 years
  • Currently prescribed hydroxyurea (HU) ≥18 months (for assessing historical hydroxyurea adherence and identify personal best)
  • ≥3 fetal hemoglobin assessments over past 12 months with pre-HbF ≥10% below historical personal best value
  • Youth has/uses cell phone with text message capability
  • Youth able to speak/read English or Spanish.
  • Youth willing to participate
  • Parent:
  • Parent/guardian speaks/reads English or Spanish
  • Parent/ legal guardian willing to participate
  • Family expected to reside in community for ≥ 1 years

You may not qualify if:

  • Youth:
  • A different sickle type
  • Youth \< 10 years of age or ≥ 18 years of age
  • Youth not prescribed hydroxyurea, or on chronic transfusions
  • \<3 fetal hemoglobin assessments over past 12 months
  • Sexually active female ≥11 not using reliable contraception (due to hydroxyurea teratogenic risk)
  • Pregnancy
  • Cognitive impairment (\>1 level below expected grade)
  • Youth not residing with parent/legal guardian
  • Sibling of a youth enrolled in this study
  • Parent:
  • Parent/legal guardian is not the primary caregiver
  • Youth in foster care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center - Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (7)

  • Smaldone A, Stockwell MS, Osborne JC, Cortes Y, Bekele E, Green NS. Adolescent and parent use of new technologies for health communication: a study in an urban latino community. J Public Health Res. 2015 Feb 19;4(1):376. doi: 10.4081/jphr.2015.376. eCollection 2015 Feb 20.

    PMID: 25918691RESULT

  • Bekele E, Thornburg CD, Brandow AM, Sharma M, Smaldone AM, Jin Z, Green NS. Do difficulties in swallowing medication impede the use of hydroxyurea in children? Pediatr Blood Cancer. 2014 Sep;61(9):1536-9. doi: 10.1002/pbc.25073. Epub 2014 Apr 17.

    PMID: 24753149RESULT

  • Green NS, Manwani D, Matos S, Hicks A, Soto L, Castillo Y, Ireland K, Stennett Y, Findley S, Jia H, Smaldone A. Randomized feasibility trial to improve hydroxyurea adherence in youth ages 10-18 years through community health workers: The HABIT study. Pediatr Blood Cancer. 2017 Dec;64(12):10.1002/pbc.26689. doi: 10.1002/pbc.26689. Epub 2017 Jun 23.

    PMID: 28643377RESULT

  • Osborne JC, Green NS, Smaldone AM. Quality of Life of Latino and Non-Latino Youth With Sickle Cell Disease as Reported by Parents and Youth. Hisp Health Care Int. 2020 Dec;18(4):224-231. doi: 10.1177/1540415320908525. Epub 2020 Mar 3.

    PMID: 32124643RESULT

  • Smaldone A, Findley S, Manwani D, Jia H, Green NS. HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease. J Pediatr. 2018 Jun;197:177-185.e2. doi: 10.1016/j.jpeds.2018.01.054. Epub 2018 Mar 20.

    PMID: 29571930RESULT

  • Smaldone A, Manwani D, Green NS. Greater number of perceived barriers to hydroxyurea associated with poorer health-related quality of life in youth with sickle cell disease. Pediatr Blood Cancer. 2019 Jul;66(7):e27740. doi: 10.1002/pbc.27740. Epub 2019 Apr 2.

    PMID: 30941907RESULT

  • Smaldone A, Findley S, Bakken S, Matiz LA, Rosenthal SL, Jia H, Matos S, Manwani D, Green NS. Study protocol for a randomized controlled trial to assess the feasibility of an open label intervention to improve hydroxyurea adherence in youth with sickle cell disease. Contemp Clin Trials. 2016 Jul;49:134-42. doi: 10.1016/j.cct.2016.06.004. Epub 2016 Jun 17.

    PMID: 27327779DERIVED

MeSH Terms

Conditions

Anemia, Sickle CellMedication Adherence

Interventions

Community Health WorkersEducational Status

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Allied Health PersonnelHealth PersonnelHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Nancy Green, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 6, 2024

Record last verified: 2024-05

Locations

US(2)