An interventional study of HABIT Intervention and Standard of Care in Sickle Cell Disease, sponsored by Columbia University. Completed at 4 sites in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
Many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the investigators' recent feasibility study of the same title. Overall goals are reducing barriers to HU use and improving adherence for youth 10-18 years through creation of a daily medication habit. The goal of the proposed multi-site study is to test the efficacy of the HABIT intervention at 6 months and sustainability of the effect at 12 months.
Barriers to medication adherence are common in youth with chronic illness and are a source of racial/ethnic disparities in underserved communities. An inherited blood disease, Sickle Cell Disease (SCD) is characterized by chronic and acute illness and reduced quality of life (QOL). It affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves QOL. Poor adherence is common among youth and young adults with SCD.
The importance of poor medication adherence, use of community-based health workers (CHWs) to bridge the gap between health services and underserved parent-youth dyads affected by SCD, the strength of the science, the success of the investigators' multi-ethnic feasibility study, and the potential application of study findings to youth with other serious chronic illnesses speak to the importance of this trial.
1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 762 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.
Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Youth:
Inclusion Criteria - Parent:
Exclusion Criteria - Youth:
Exclusion Criteria - Parent:
Dyads randomized to the control group will receive: Standard care and Education handouts.
Other: Standard of Care · Other: Education materials
In addition to standard care and education handouts, dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
Behavioral: HABIT Intervention · Other: Standard of Care · Other: Education materials
Dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
Standard of care used to treat patients with SCD
Education materials provided to all patients enrolled in the trial
Mean Change in Biomarker Fetal Hemoglobin (HbF)
A serum biomarker obtained from youth used to measure adherence to hydroxyurea
Time frame: Baseline, 6 months, 12 months
Mean Change in Proportion of Days Covered (PDC) by Hydroxyurea
The days covered by hydroxyurea was assessed using youth prescription refill data and was used to measure hydroxyurea adherence. The baseline measure is the proportion of days covered by hydroxyurea in the year prior to study enrollment, using prescription refill data.
Time frame: Baseline, 6 months, 12 months
Mean Change in Youth Score on Peds Quality of Life (Generic Quality of Life)
Used to measure health-related quality of life. Scores range from 0-100 with a higher score indicating a better quality of life.
Time frame: Baseline, 4 months, 9 months and 12 months
Mean Change in Youth Score on PedsQL Sickle Cell Disease Module (Disease Specific Quality of Life)
Used to measure sickle cell disease specific health-related quality of life. Scores range from 0-100 with a higher score indicating a better quality of life.
Time frame: Baseline, 9 months and 12 months
Mean Change in Parent Youth Concordance Regarding Self-management Responsibility
Concordance between parent and youth scores Sickle Cell Family Responsibility scores for 11 items measuring self-management tasks. Scores range from 0-11 with a higher score indicating better concordance.
Time frame: Baseline, 6 months and 12 months
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 24 | 26 |
| Completed | 22 | 23 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 2 | 3 |
A serum biomarker obtained from youth used to measure adherence to hydroxyurea
| Percent fetal hemoglobin | Intervention Group | Control Group |
|---|---|---|
| Baseline to Month 6 | 2.7 ± 1.3 | 0.3 ± 1.3 |
| Month 6 to Month 12 | -1.7 ± 1.2 | 1.8 ± 1.3 |
The days covered by hydroxyurea was assessed using youth prescription refill data and was used to measure hydroxyurea adherence. The baseline measure is the proportion of days covered by hydroxyurea in the year prior to study enrollment, using prescription refill data.
| change in percentage of PDC | Intervention Group | Control Group |
|---|---|---|
| Baseline and 6 months | 17.9 ± 27.3 | 13.1 ± 29.7 |
| 6 months and 12 months | -1.6 ± 22.8 | -1.9 ± 33.7 |
Used to measure health-related quality of life. Scores range from 0-100 with a higher score indicating a better quality of life.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline to 9 months | 10.3 ± 12.6 | 2.0 ± 12.3 |
| 9 months to 12 months | -2.5 ± 11.6 | 1.1 ± 16.2 |
Used to measure sickle cell disease specific health-related quality of life. Scores range from 0-100 with a higher score indicating a better quality of life.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline to 9 months | 16.4 ± 23.3 | 9.0 ± 12.0 |
| 9 months to 12 months | -4.3 ± 21.9 | -0.7 ± 15.7 |
Concordance between parent and youth scores Sickle Cell Family Responsibility scores for 11 items measuring self-management tasks. Scores range from 0-11 with a higher score indicating better concordance.
| units on a scale | Intervention Group | Control Group |
|---|---|---|
| Baseline to 6 months | 1.6 ± 2.4 | 1.4 ± 2.5 |
| 6 months to 12 months | 0.3 ± 2.1 | 0.5 ± 2.3 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Intervention Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
The following variables were collected for children: Age, Sex, Race, Ethnicity, No other chronic conditions besides sickle cell disease, Number of emergency room visits, Number of hospitalizations, Biomarker fetal hemoglobin, Proportion of days covered by hydroxyurea The following variables were collected for parent/primary caregiver: Parent status, Parent education, Caregiver affected by sickle cell disease, Other people at home affected by sickle cell disease
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 14.1 ± 1.9 | 13.0 ± 1.7 | 13.3 ± 1.9 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 12 | 11 | 23 |
| Male | 12 | 15 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 21 | 21 | 42 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 21 | 20 | 41 |
| White | 0 | 0 | 0 |
| More than one race | 3 | 6 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 24 | 26 | 50 |
| No other chronic condition besides Sickle Cell Disease (SCD)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 12 | 13 | 25 |
| Had 1 or more ED visits in past year(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 11 | 10 | 21 |
| Had 1 more hospitalizations in past year(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 11 | 11 | 22 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Aug 2018 to primary completion in Dec 2021, 40 months.
Results were first posted in Jun 2024, 2 years 5 months after primary completion. A results delay was requested in Nov 2022.
Of 164 non-industry interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's 40 months is above that.
Counting every sponsor, half of 172 studies reached it within 28 months; a quarter within 15 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.