Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - 18 |
| Updated: | 12/3/2017 |
| Start Date: | September 2013 |
| End Date: | December 2015 |
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.
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.
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.
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.
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
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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