Sickle Cell DiseaseHABITNCT02029742
Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
A study testing Community Health Worker (CHW) and Education in people with Sickle Cell Disease, run by Columbia University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Community Health Worker (CHW) and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 13Show fewer
- Youth able to speak/read English or Spanish.
- Youth willing to participate
- Parent:
- Parent/legal guardian meets all inclusion criteria
- Parent/guardian speaks/reads English or Spanish
- Parent/ legal guardian willing to participate
- Family expected to reside in community for ≥ 1 years
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Montefiore Medical Center - Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Community Health Worker (CHW), Education
- Keywords
- Sickle cell disease, Medication adherence, Hydroxyurea, Community health worker intervention, Sickle Cell Treatment
- Medical subject headings
- Anemia, Sickle Cell, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW)Behavioural
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.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Montefiore Medical Center
- Responsible party
- Principal investigator, Nancy Green, Columbia University
- Investigators
- Nancy Green, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029742
- Sponsor's protocol ID
- AAAJ7350
- Other IDs
- R21NR013745
- Acronym
- HABIT
- Status last verified
- May 2024
- First submitted
- 6 Jan 2014
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25918691Bekele 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.
PubMed 24753149Green 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.
PubMed 28643377Osborne 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.
PubMed 32124643Smaldone 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.
PubMed 29571930Smaldone 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.
PubMed 30941907Smaldone 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.
PubMed 27327779
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABIT
- ClinicalTrials.gov ID
- NCT02029742
- Acronym / sponsor ID
- HABIT / AAAJ7350
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Medication adherence, Hydroxyurea, Community health worker intervention, Sickle Cell Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Montefiore Medical Center
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Intervention | Experimental | Behavioral: Community Health Worker (CHW)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. |
| Education | Active comparator | Behavioral: EducationThose 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Community Health Worker Intervention |
| EducationDyads 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. | Behavioural | Education |
Primary outcome
Effect size of the intervention on hydroxyurea (HU) adherence
Time frame: 6 months
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.
3 secondary outcomes
Effect size of the intervention on youth-parent communication about self-management responsibility
Time frame: 6 months
Effect size of the intervention on youth-parent communication about quality of life (QOL)
Time frame: 6 months
Effect size of the intervention on youth-parent communication about resource use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Results publication: PubMed 25918691Smaldone 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.
- Results publication: PubMed 24753149Bekele 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.
- Results publication: PubMed 28643377Green 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.
- Results publication: PubMed 32124643Osborne 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.
- Results publication: PubMed 29571930Smaldone 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.
- Results publication: PubMed 30941907Smaldone 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.
- Derived from this study: PubMed 27327779Smaldone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Green, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW) and Education in people with Sickle Cell Disease, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect size of the intervention on hydroxyurea (HU) adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02029742, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.