Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT

Sickle Cell Disease Clinical Trial

— HABIT  

Official title:

Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029742
• Other study ID #: AAAJ7350
• Secondary ID: R21NR013745
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• Community Health Worker (CHW)
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.
• Education
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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center - Albert Einstein College of Medicine	Bronx	New York
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Montefiore Medical Center, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Pedi — View 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. — View 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: 10.10 — View 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 Ap — View 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. eColle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect size of the intervention on youth-parent communication about self-management responsibility	The investigators will estimate the effect size of the intervention on youth-parent communication about self-management responsibility by assessing quantitative changes in questionnaires administered to both parents and youth.	6 months
Secondary	Effect size of the intervention on youth-parent communication about quality of life (QOL)	The investigators will estimate the effect size of the intervention on youth-parent communication about quality of life by assessing quantitative changes in in general pediatric and Sickle Cell disease Quality of Life questionnaires administered to both parents and youths.	6 months
Secondary	Effect size of the intervention on youth-parent communication about resource use	The investigators will estimate the effect size of the intervention on youth-parent communication about resource use, such as urgent outpatient appointments, emergency room visits, hospitalizations, missed days from school and parent productivity by assessing quantitative changes in questionnaires administered to parents.	6 months