Evidence map›Paper›PMID 33644492›Full record

ArticleContemporary clinical trials communications2021

Design, methods, and baseline characteristics of a pilot, randomized, controlled trial of the effects of an electronic monitoring device on medication adherence in children with asthma.

JessicaP Hollenbach, Tregony Simoneau, Ye Sun, Iris Becene, Sigrid Almeida, Christine Langton, Glenn Flores

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03734861 (A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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.

NCT03734861 nacompletednot on this map

A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback

TypeinterventionalSponsorConnecticut Children's Medical CenterRan2018 to 2020Enrolled75ConditionsAsthmaArmsBreatheSmart System, Standard of Care
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
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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

7 authors at 4 institutions in 1 country.

JessicaP HollenbachConnecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.
Tregony SimoneauDivision of Pulmonary Medicine, Boston Children's Hospital, Harvard Medical School, 300 Longwood Ave, Boston, MA, 02115, USA.
Ye SunChildren's Hospital at Montefiore, 3415 Bainbridge Ave, Bronx, NY, 10467, USA.
Iris BeceneTufts University, 419 Boston Ave, Medford, MA, 02155, USA.
Sigrid AlmeidaConnecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.
Christine LangtonConnecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.
Glenn FloresConnecticut Children's Medical Center, 282 Washington Street, Hartford, CT, 06106, USA.
Connecticut Children's Medical Center · USBoston Children's Hospital · USChildren's Hospital at Montefiore · USTufts University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

NON-ADHERENCE TO MEDICATION IS COMMON: Current methods of assessing adherence are inaccurate. Electronic monitoring devices (EMDs) may more accurately assess adherence, but are not currently used in practice. The design, methods, and participant baseline characteristics are described for a pilot trial of the effects of an EMD on asthma medication adherence in a pediatric population.This was a pilot, randomized, controlled trial of children with persistent asthma managed with daily inhaled corticosteroids (ICS). Seventy-five children were randomized 2:1 to receive either two EMDs (one for ICS and one for rescue) linked via Bluetooth to a mobile application (app) or standard of care (controls). EMDs recorded dates and times of inhaler actuations and the app sent daily medication reminders to participants. Controls were provided standard care. Medication adherence was measured using pharmacy refill records and self-report, whereas EMD data were used to measure adherence in the intervention group. Secondary outcomes included asthma control, pulmonary function, and quality of life.

resultsOne hundred sixty children were screened for eligibility, with 123 individuals excluded. Seventy-five children were enrolled, with 25 allocated to the control group and 50 to the intervention. The mean age of participants is 12 years old (±2.9), with equal proportions of male and female children; 45% are Latinx and 19% African-American; 77% report Medicaid or CHIP coverage. Half of participants have moderate persistent asthma and 48% had marginally controlled asthma at time of enrollment. There were no significant inter-group differences in baseline sociodemographic characteristics.

conclusionThis pilot successfully reached target populations and met recruitment and enrollment goals. It is addressing an important knowledge gap by evaluating the effects of an EMD with a mobile app on adherence rates, findings which could prove useful in determining whether routine use of EMDs in clinical practice help children achieve better asthma control and outcomes. CLINICAL TRIALSGOV: NCT03734861.

Indexed as

AdherenceAsthmaChildrenElectronic monitoring deviceMobile health

Identifiers

PMID33644492
PMCPMC7887642
OpenAlexW3127313217

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.