Clinical trial NCT02029742: Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
Official title: Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease
Medication adherence
Hydroxyurea
Community health worker intervention
Sickle Cell Treatment
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Montefiore Medical Center
First posted: 2014-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Sickle cell disease (SCD) is an inherited disorder affecting the blood and causes anemia, painful sickle crises, organ damage, reduced quality of life and high health care use. Hydroxyurea (HU) is an oral medication that reduces disease symptoms and improves quality of life by increasing the amount of fetal hemoglobin in the blood. Despite the clinical promise of hydroxyurea, many children with SCD do make taking hydroxyurea a daily health habit. General barriers to medication adherence in underserved populations include lack of trust of medical staff, incomplete knowledge regarding benefits of hydroxyurea, and other factors that impede access to care such as transportation difficulties. Challenges specific to hydroxyurea use include understanding the importance of maximizing fetal hemoglobin levels and addressing concerns about hydroxyurea. Children and adolescents also require that a developmentally appropriate transition of self-management be established with their parents. Community-based health workers are a well established means to provide support for chronic disease management for underserved families and address multi-faceted barriers through culturally, behaviorally and developmentally aligned intervention. The investigators hypothesize that Community Health Workers support, augmented by daily task-focused communication technology, can improve self-managed adherence to hydroxyurea.

Eligibility criteria: Inclusion Criteria:

Youth:

1. Sickle type - homozygous sickle disease or sickle-beta thalassemia disease
2. Age 10 to 18 years
3. Currently prescribed hydroxyurea (HU) ≥18 months (for assessing historical hydroxyurea adherence and identify personal best)
4. ≥3 fetal hemoglobin assessments over past 12 months with pre-HbF ≥10% below historical personal best value
5. Youth has/uses cell phone with text message capability
6. Youth able to speak/read English or Spanish.
7. Youth willing to participate

Parent:

1. Parent/legal guardian meets all inclusion criteria
2. Parent/guardian speaks/reads English or Spanish
3. Parent/ legal guardian willing to participate
4. Family expected to reside in community for ≥ 1 years

Exclusion Criteria:

Youth:

1. A different sickle type
2. Youth \< 10 years of age or ≥ 18 years of age
3. Youth not prescribed hydroxyurea, or on chronic transfusions
4. \<3 fetal hemoglobin assessments over past 12 months
5. Sexually active female ≥11 not using reliable contraception (due to hydroxyurea teratogenic risk)
6. Pregnancy
7. Cognitive impairment (\>1 level below expected grade)
8. Youth not residing with parent/legal guardian
9. Sibling of a youth enrolled in this study

Parent:

1. Parent/legal guardian is not the primary caregiver
2. Youth in foster care

Primary outcomes:
measure: Effect size of the intervention on hydroxyurea (HU) adherence
timeFrame: 6 months
Secondary outcomes:
measure: Effect size of the intervention on youth-parent communication about self-management responsibility
timeFrame: 6 months
measure: Effect size of the intervention on youth-parent communication about quality of life (QOL)
timeFrame: 6 months
measure: Effect size of the intervention on youth-parent communication about resource use
timeFrame: 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center - Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Nancy Green, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.