HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease

Arlene Smaldone, Sally Findley, Deepa G. Manwani, Haomiao Jia, Nancy S. Green

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objectives: To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. Study design: We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. Results: A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, −0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. Conclusions: These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. Trial registration: ClinicalTrials.gov: NCT02029742.

Original languageEnglish (US)
JournalJournal of Pediatrics
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Hydroxyurea
Sickle Cell Anemia
Quality of Life
Text Messaging
Self Care
Emotions
Feasibility Studies
Proxy
Nonparametric Statistics
Hispanic Americans
Parents
Communication
Control Groups
Therapeutics
Growth
Research

Keywords

  • community health worker
  • health related quality of life
  • hydroxyurea
  • medication adherence
  • sickle cell disease

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease. / Smaldone, Arlene; Findley, Sally; Manwani, Deepa G.; Jia, Haomiao; Green, Nancy S.

In: Journal of Pediatrics, 01.01.2018.

Research output: Contribution to journalArticle

@article{c1221c77849942bab6e76a2d5e11712d,
title = "HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease",
abstract = "Objectives: To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. Study design: We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. Results: A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50{\%} Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7{\%} attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95{\%} CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95{\%} CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95{\%} CI, 8.5-51.5), Emotions (37.0 points, 95{\%} CI, 9.4-64.5), and Communication I (17.8 points; 95{\%} CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95{\%} CI, −0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. Conclusions: These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. Trial registration: ClinicalTrials.gov: NCT02029742.",
keywords = "community health worker, health related quality of life, hydroxyurea, medication adherence, sickle cell disease",
author = "Arlene Smaldone and Sally Findley and Manwani, {Deepa G.} and Haomiao Jia and Green, {Nancy S.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.jpeds.2018.01.054",
language = "English (US)",
journal = "Journal of Pediatrics",
issn = "0022-3476",
publisher = "Mosby Inc.",

}

TY - JOUR

T1 - HABIT, a Randomized Feasibility Trial to Increase Hydroxyurea Adherence, Suggests Improved Health-Related Quality of Life in Youths with Sickle Cell Disease

AU - Smaldone, Arlene

AU - Findley, Sally

AU - Manwani, Deepa G.

AU - Jia, Haomiao

AU - Green, Nancy S.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objectives: To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. Study design: We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. Results: A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, −0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. Conclusions: These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. Trial registration: ClinicalTrials.gov: NCT02029742.

AB - Objectives: To examine the effect of a community health worker (CHW) intervention, augmented by tailored text messages, on adherence to hydroxyurea therapy in youths with sickle cell disease, as well as on generic and disease-specific health-related quality of life (HrQL) and youth-parent self-management responsibility concordance. Study design: We conducted a 2-site randomized controlled feasibility study (Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment [HABIT]) with 2:1 intervention allocation. Youths and parents participated as dyads. Intervention dyads received CHW visits and text message reminders. Data were analyzed using descriptive statistics, the Wilcoxon signed-rank test, and growth models adjusting for group assignment, time, and multiple comparisons. Changes in outcomes from 0 to 6 months were compared with their respective minimal clinically important differences. Results: A total of 28 dyads (mean age of youths, 14.3 ± 2.6 years; 50% Hispanic) participated (18 in the intervention group, 10 in the control group), with 10.7% attrition. Accounting for group assignment, time, and multiple comparisons, at 6 months intervention youths reported improved generic HrQL total score (9.8 points; 95% CI, 0.4-19.2) and Emotions subscale score (15.0 points; 95% CI, 1.6-28.4); improved disease-specific subscale scores for Worry I (30.0 points; 95% CI, 8.5-51.5), Emotions (37.0 points, 95% CI, 9.4-64.5), and Communication I (17.8 points; 95% CI, 0.5-35.1); and 3-month dyad self-management responsibility concordance (3.5 points; 95% CI, −0.2 to 7.1). There were no differences in parent proxy-reported HrQL measures at 6 months. Conclusions: These findings add to research examining effects of behavioral interventions on HrQL outcomes in youths with sickle cell disease. Trial registration: ClinicalTrials.gov: NCT02029742.

KW - community health worker

KW - health related quality of life

KW - hydroxyurea

KW - medication adherence

KW - sickle cell disease

UR - http://www.scopus.com/inward/record.url?scp=85044100048&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044100048&partnerID=8YFLogxK

U2 - 10.1016/j.jpeds.2018.01.054

DO - 10.1016/j.jpeds.2018.01.054

M3 - Article

JO - Journal of Pediatrics

JF - Journal of Pediatrics

SN - 0022-3476

ER -