Evidence map›Paper›PMID 38917111›Full record

ArticlePloS one2024

Study protocol for ADHERE (Applying Directly observed therapy to HydroxyurEa to Realize Effectiveness): Using small business partnerships to deliver a scalable and novel hydroxyurea adherence solution to youth with sickle cell disease.

Joseph Walden, Lauren Brown, Sebastian Seiguer, Katie Munshaw, Joseph Rausch, Sherif Badawy, Patrick McGann, Savannah Winkler, Lisbel Gonzalez, Susan Creary

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06264700 (Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT06264700 nacompletednot on this map

Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

TypeinterventionalSponsorNationwide Children's HospitalRan2024 to 2026Enrolled60ConditionsSickle Cell DiseaseArmsVideo Directly Observed Therapy (VDOT), Health Reminder Tip Alerts
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

10 authors.

Joseph WaldenCenter for Child Health Equity and Outcomes Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America.ORCID 0000-0002-4111-1845
Lauren Brownemocha Mobile Health Inc. Doing Business as Scene and Scene Health, Baltimore, MD, United States of America.
Sebastian Seigueremocha Mobile Health Inc. Doing Business as Scene and Scene Health, Baltimore, MD, United States of America.
Katie Munshawemocha Mobile Health Inc. Doing Business as Scene and Scene Health, Baltimore, MD, United States of America.
Joseph RauschCenter for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America.
Sherif BadawyDivision of Hematology, Oncology, and Stem Cell Transplant, Lurie Children's Hospital of Chicago, Chicago, IL, United States of America.
Patrick McGannLifespan Comprehensive Sickle Cell Center, Providence, RI, United States of America.
Savannah WinklerDivision of Hematology, Oncology, and Stem Cell Transplant, Lurie Children's Hospital of Chicago, Chicago, IL, United States of America.
Lisbel GonzalezLifespan Comprehensive Sickle Cell Center, Providence, RI, United States of America.
Susan CrearyCenter for Child Health Equity and Outcomes Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America.ORCID 0000-0002-4730-8139

Funding

ADHERE (Applying Directly observed therapy to HydroxyurEa to Realize Effectiveness)R44HL169085 · NHLBI · EMOCHA MOBILE HEALTH, INC. · PI Sebastian Seiguer · 2023 to 2026
$2.0M
NHLBI NIH HHS R44 HL169085
6 · The paper itself

Abstract

Sickle cell disease (SCD) is an inherited blood disorder that affects approximately 100,000 Americans, primarily from underrepresented racial minority populations, and results in costly, multi-organ complications. Hydroxyurea, the primary disease-modifying therapy for SCD, is effective at reducing most complications; however, adherence to hydroxyurea remains suboptimal and is the primary barrier to clinical effectiveness. Video directly observed therapy (VDOT) has shown promise as an adherence-promoting intervention for hydroxyurea, yet previous VDOT trials were limited by high attrition from gaps in technology access, use of unvalidated adherence measures, and healthcare system limitations of delivering VDOT to patients. As such, we fostered a small business partnership to compare VDOT for hydroxyurea to attention control to address previous shortcomings, promote equitable trial participation, and maximize scalability. VDOT will be administered by Scene Health (formerly emocha Health) and adherence monitoring will be performed using a novel electronic adherence monitor developed to meet the unique needs of the target population. Adolescent and young adult patients as well as caregivers of younger patients (<11 years of age) will be recruited. In addition to visit incentives, all participants will be offered a smartphone with a data plan to ensure all participants have equal opportunity to complete study activities. The primary objectives of this pilot, multi-center, randomized controlled trial (RCT) are to assess retention and sustained engagement and to explore needs and preferences for longer-term adherence monitoring and interventions. This RCT is registered with the National Institutes of Health (NCT06264700). Findings will inform a future efficacy RCT applying VDOT to hydroxyurea to address adherence gaps and improve outcomes within this vulnerable population.

Indexed as

Anemia, Sickle CellHydroxyureaAdolescentAdultAntisickling AgentsChildFemaleHumansMaleMedication AdherenceMulticenter Studies as TopicRandomized Controlled Trials as TopicYoung AdultAntisickling AgentsHydroxyurea

Identifiers

PMID38917111
PMCPMC11198815

What OpenQuestion holds

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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.