Community health worker intervention may benefit adolescents with sickle cell disease

Arlene Smaldone

Adolescents with sickle cell disease who received visits and text messages from community health workers reported improved health-related quality of life, according to results of a two-site randomized controlled feasibility study.

Researchers conducted the HABIT trial to assess whether a community health worker intervention improved hydroxyurea adherence among youth with sickle cell disease. Investigators also evaluated whether the intervention affected generic or disease-specific health-related quality of life, as well as youth-parent self-management responsibility concordance.

The trial included 28 parent-youth dyads (youth age range, 10 to 18 years; median, 14.3 years; 50% Hispanic). Eighteen dyads received an intervention that consisted of visits from community health workers and text messages. The other 10 dyads served as the control group.

Results published last year in Pediatric Blood & Cancer suggested the intervention improved hydroxyurea adherence.

In the first 4 months, participants assigned the intervention demonstrated a 2.3% reduction per month from their historical personal best hydroxyurea-induced hemoglobin F level. Pharmacy records suggested similar improvement in adherence.

A paper published this summer in The Journal of Pediatrics summarized quality-of-life results.

At 6 months, youths in the intervention group reported improvement in generic health-related quality of life total scores (9.8 points; 95% CI, 0.4-19.2) and emotions subscale scores (15 points; 95% CI, 1.6-28.4). Results also showed improvements in disease-specific subscale scores for worry (30 points; 95% CI, 8.5-51.5), emotions (37 points; 95% CI, 9.4-64.5) and communication (17.8 points; 95% CI, 0.5-35.1).

Researchers reported a 3.5-point (95% CI, –0.2 to 7.1) improvement in dyad self-management responsibility concordance at 3 months in the intervention group.

Results of the trial — led by Arlene Smaldone, PhD, professor and assistant dean of scholarship and research at Columbia University School of Nursing, along with Nancy S. Green, MD, pediatric hematologist and associate director of Irving Institute for Clinical and Translational Research at Herbert Irving Comprehensive Cancer Center — laid the groundwork for a larger four-site randomized controlled trial that will further assess the intervention.

HemOnc Today spoke with Smaldone about the results of the feasibility study and their potential implications, how community health workers can help improve hydroxyurea adherence and quality of life among adolescents with sickle cell disease, and how the larger trial will build on the preliminary data.

Question: Why is hydroxyurea adherence such a concern for adolescents with sickle cell disease?

Answer: Hydroxyurea helps to reduce episodes of stroke among children with sickle cell disease. However, when people have to take medicines every day, adherence often is poor. The problem can get more accentuated with adolescents because, at this age, they are becoming more responsible for their own care. We have seen adherence drop among adolescents with other chronic conditions for a variety of reasons. One issue that may be unique to sickle cell disease is that most adolescents with this condition and their families are underserved populations, either by race or socioeconomic status. Other issues may get prioritized over the medication. If an adolescent has unstable housing or food insecurity, taking medicine might not seem like a priority.

Q: How did the HABIT feasibility study come about?

A: We knew hydroxyurea adherence was a problem. In some chronic conditions — such as diabetes and asthma — there has been considerable work with community health workers. For this project, though, we really thought it was important to include both parents and adolescents to try to have them work as a team toward better adherence.

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Q: Can you describe the study population and methods?

A: Children had to be on hydroxyurea for at least 18 months, and they needed to be deemed poorly adherent based on criteria we established related to their levels of hemoglobin F. Kids randomly assigned to the intervention group received visits from the community health workers and text message reminders, as well as educational materials about sickle cell disease and hydroxyurea. Those randomly assigned to the control group received usual care and the educational materials. We followed study participants for 6 months. They came to the clinic monthly for hemoglobin F level assessments and to complete surveys about quality of life. We also got permission to ask for their pharmacy records, so we could see how often they refilled their medicines and whether they had the right amount of medicine at home.

Q: What did the community health worker visits entail?

A: Hydroxyurea must be taken every day. To ensure good adherence, you want to build taking hydroxyurea into your life. You want to do it without having to think too hard about it. With this intervention, community health workers helped subjects to identify a habit on which a hydroxyurea habit could be built. They met with families, generally in their homes but sometimes at another location, such as a coffee shop. They tried to find ways parents and kids could work together. The goal was to have parents be supportive of their kids, while figuring out how much responsibility each child should take based on their age. The community health workers also tried to break down barriers. Housing was an issue for one family, and depression was an issue for another. They can make referrals to resolve those issues. For some adolescents, the hydroxyurea capsule is too big. If they can't swallow the capsule, a community health worker might suggest a liquid preparation to mix with something like apple sauce.

Q: How did text messages from community health workers help?

A: Community health workers helped the adolescents try to identify a habit around which they could build taking hydroxyurea. Someone might say, ‘I never forget to brush my teeth every night, so that’s a good time for me to take hydroxyurea.’ Once the habit was identified, the community health worker helped the parent and adolescent write a reminder that was used to create a text message that would be sent automatically at a certain time. If the child brushed his teeth at night, a message could be sent around that time that said, ‘Remember to leave the bottle of hydroxyurea near the bathroom sink.’

Q: Can you summarize your findings?

A: Generally, in a feasibility trial, you're looking to see if an intervention is feasible, acceptable and shows a promising effect. The intervention was feasible, it was very acceptable to families, and it did show a promising effect in relation to improving adherence and quality of life among youth with sickle cell disease. However, our sample size was small and the study findings require confirmation in a larger trial.

Q: What will the four - site randomized controlled trial entail?

A: We’re increasing the sample size from 28 parent-youth dyads to 104 dyads. The protocol and entry criteria will be very similar. Follow-up will be extended to 1 year. The intervention will happen in the first 6 months and we will see if adherence improves. In the second 6-month period, we will see if adherence improvement is sustainable. We couldn’t really test efficacy in the feasibility trial because of the small sample size. But it certainly looked like there was an effect, and our study findings strongly support doing a bigger study. We’ll also look at quality of life, and we’re going to look at other markers, including depressive symptoms, reduction of patient-reported barriers to hydroxyurea use, and health care utilization. – by Joe Gramigna

References:

Green NS, et al. Pediatr Blood Cancer. 2017;doi:10.1002/pbc.26689.

Smaldone A, et al. J Pediatr. 2018;doi:10.1016/j.peds.2018.01.054.

For more information:

Arlene Smaldone, PhD, can be reached at ams130@cumc.columbia.edu.

Disclosure: Smaldone reports no relevant financial disclosures.