Evidence map›Paper›PMID 31615480›Full record

ArticleBMC pediatrics2019

HABIT efficacy and sustainability trial, a multi-center randomized controlled trial to improve hydroxyurea adherence in youth with sickle cell disease: a study protocol.

Arlene Smaldone, Deepa Manwani, Banu Aygun, Kim Smith-Whitley, Haomiao Jia, Jean-Marie Bruzzese, Sally Findley, Joshua Massei, Nancy S Green

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03462511 (Hydroxyurea Adherence for Personal Best in Sickle Cell Disease), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03462511 nacompletednot on this map

Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial

TypeinterventionalSponsorColumbia UniversityRan2018 to 2021Enrolled50ConditionsSickle Cell DiseaseArmsHABIT Intervention, Standard of Care, Education materials
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Arlene SmaldoneColumbia University School of Nursing, New York, NY, USA. ams130@columbia.edu.ORCID 0000-0001-8326-5036
Deepa ManwaniAlbert Einstein College of Medicine, Bronx, NY, USA.
Banu AygunZucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, USA.
Kim Smith-WhitleyPerelman School of Medicine, Philadelphia, PA, USA.
Haomiao JiaColumbia University School of Nursing, New York, NY, USA.
Jean-Marie BruzzeseColumbia University School of Nursing, New York, NY, USA.
Sally FindleyMailman School of Public Health, New York, NY, USA.
Joshua MasseiColumbia University School of Nursing, New York, NY, USA.
Nancy S GreenVagelos College of Physicians and Surgeons, Columbia University, New York, NY, USA.
Columbia University · USAlbert Einstein College of Medicine · USHofstra University · US

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Reaching Communities through the Design of Information Visualizations (ReDIVis) Toolbox to Address COVID-19 Vaccine Hesitancy and Uptake.P30NR016587 · NINR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BAKKEN, SUZANNE, SMALDONE, ARLENE M · 2016 to 2022
$4.3M
Hydroxyurea Adherence for Personal Best in Sickle Cell Treatment: HABITR01NR017206 · NINR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GREEN, NANCY S., SMALDONE, ARLENE M · 2017 to 2020
$2.9M
NCATS NIH HHS UL1 TR001873NINR NIH HHS P30 NR016587NINR NIH HHS R01 NR017206
6 · The paper itself

Abstract

backgroundHydroxyurea (HU) is recommended as standard practice for youth with sickle cell disease (SCD). Yet, despite its efficacy, HU adherence in adolescents and young adults is often poor. Poor medication adherence increases disease burden, healthcare cost and widens health disparities. Adolescence is a critical time to improve adherence through improved chronic disease self-management. This study aims to test the efficacy of an intervention delivered to youth/parent dyads by community health workers (CHWs), augmented by tailored text messages on HU adherence (primary outcome). Secondary outcomes are intervention sustainability, youth health-related quality of life, self-management responsibility concordance, acute hospital use and self-reported disease symptoms.

methodsHydroxyurea Adherence for Personal Best in Sickle Cell Disease, "HABIT," is a 12 month multi-center randomized controlled trial. One hundred four youth, 10 to 18 years of age prescribed HU who meet eligibility criteria, enrolled with their parent as dyads, will be randomized 1:1 to either the HABIT intervention or to usual clinical care plus education handouts. All subjects will complete clinic visits at months 0, 2, 4, 6 (efficacy component), 9 and 12 (sustainability component) for assessment of HbF biomarker, other hematologic parameters, and to complete questionnaires. In addition, dyads assigned to the HABIT intervention will work with CHWs to identify a daily habit (e.g., brushing teeth) on which to build a HU adherence habit. Tailored daily text message reminders to support the habit will be developed by the dyad in collaboration with the CHWs and sent to parent and youth. At the 6 month visit, the intervention will end and the sustainability portion of the trial will begin. All data analyses will be based on intention to treat with all randomized subjects included in the analyses. DISCUSSION: Prior retrospective studies demonstrate that a majority of adolescents are poorly adherent to HU. If efficacious, the HABIT intervention has the potential to improve the lives of youth with SCD.

trial registrationClinicaltrials.gov NCT03462511 . Registered March 6, 2018, last updated July 26, 2019.

Indexed as

Drug MonitoringAdolescentAnemia, Sickle CellAntisickling AgentsChildHumansHydroxyureaMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeAntisickling AgentsHydroxyureaAdherenceCommunity health workersHealth related quality of lifeHydroxyureaMobile healthRandomized controlled trialSickle cell disease

Identifiers

PMID31615480
PMCPMC6792326
OpenAlexW2980944976

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.