Evidence map›Paper›PMID 32320052›Full record

Trial reportHeadache2020

Digital Therapeutic Self-Management Intervention in Adolescents With Migraine: Feasibility and Preliminary Efficacy of "Migraine Manager".

Kevin A Hommel, Julia Carmody, Andrew D Hershey, Christina Holbein, Marielle Kabbouche-Samaha, James Peugh, Scott Powers

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Headache, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Review
  7. Digital therapeutics in neurology.Journal of neurology · 2022
    Review
  8. Article
  9. Review
  10. Article
  11. Article
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 1 institution in 1 country.

Kevin A HommelDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Julia CarmodyDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Andrew D HersheyDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.ORCID 0000-0002-1598-7536
Christina HolbeinDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Marielle Kabbouche-SamahaDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
James PeughDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Scott PowersDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Cincinnati Children's Hospital Medical Center · US

Funding

MigraineManager: A Self-Management Health Care Resource for Pediatric MigraineR21NS094476 · NINDS · CINCINNATI CHILDRENS HOSP MED CTR · PI HOMMEL, KEVIN · 2016 to 2017
$429k
NINDS NIH HHS NS094476NINDS NIH HHS R21 NS094476
6 · The paper itself

Abstract

objectiveThe objective of this study was to design, code, and pilot test the feasibility and preliminary efficacy of a self-management digital therapeutic tool for adolescents with migraine.

backgroundSelf-management of migraine in adolescents is complex and has important implications for health outcomes. A comprehensive and accessible approach to self-management is needed for youth with migraine, their parents, and clinicians.

methodsAn iterative co-design process was used to develop and optimize the Migraine Manager's digital therapeutic self-management tool. Subsequently, 40 adolescents, age 11-18 years, were enrolled in an 8-week single-arm open label trial (N = 36 analyzed). The primary outcome was headache days.

resultsUsage data for Migraine Manager were similar to other health app usage data and feedback from participants was uniformly positive, indicating acceptable feasibility. Preliminary efficacy was demonstrated by a reduction in headache days from 17.2 ± 8.5 at baseline to 7.9 ± 7.2 at 8 weeks (95% CI, -13.0 to -7.8; P < .001). There was also statistically significant improvement in patient physical functioning quality of life reported by both patients (baseline = 55.7 ± 20.4; 8 weeks = 69.7 ± 21.9, P = .005) and parents (baseline = 58.5 ± 22.8; 8 weeks = 74.3 ± 18.1, P = .002), and in parent-reported ingestion issues subscale of the adherence barriers scale from baseline to 8 weeks (baseline = 6.0 ± 2.6; 8 weeks = 5.2 ± 3.0, P = .020).

conclusionsA self-management digital therapeutic tool for adolescents with migraine can offer care to patients who might not otherwise receive such services. Migraine Manager demonstrated the feasibility and preliminary efficacy in this pilot trial, highlighting the potential beneficial impact of this tool. Larger controlled trials with long-term follow-up are needed to definitively determine the clinical efficacy of Migraine Manager.

Indexed as

Internet-Based InterventionOutcome and Process Assessment, Health CareSelf-ManagementAdolescentChildFeasibility StudiesFemaleHumansMaleMigraine DisordersParentsPatient CompliancePilot ProjectsadolescentHeadachemigrainepediatricself-managementtechnology

Identifiers

PMID32320052
PMCPMC7263949
OpenAlexW3017330518

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.