Characteristics of Neuropsychiatric Mobile Health Trials: Cross-Sectional Analysis of Studies Registered on ClinicalTrials.gov.
Alzheimer disease
alcohol use disorders
anxiety disorders
apps
epilepsy
major depressive disorder
mental health
migraine
mobile phones
opioid use disorders
regulation
schizophrenia
smartphones
stroke
Journal
JMIR mHealth and uHealth
ISSN: 2291-5222
Titre abrégé: JMIR Mhealth Uhealth
Pays: Canada
ID NLM: 101624439
Informations de publication
Date de publication:
04 08 2020
04 08 2020
Historique:
received:
07
09
2019
accepted:
26
01
2020
revised:
21
11
2019
entrez:
5
8
2020
pubmed:
5
8
2020
medline:
18
3
2021
Statut:
epublish
Résumé
The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study. The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results. We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions. Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health. Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.
Sections du résumé
BACKGROUND
The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study.
OBJECTIVE
The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results.
METHODS
We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions.
RESULTS
Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health.
CONCLUSIONS
Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.
Identifiants
pubmed: 32749230
pii: v8i8e16180
doi: 10.2196/16180
pmc: PMC7473471
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e16180Subventions
Organisme : NCCIH NIH HHS
ID : K23 AT009706
Pays : United States
Informations de copyright
©Mia Tova Minen, Julia Frederica Reichel, Pallavi Pemmireddy, Elizabeth Loder, John Torous. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 04.08.2020.
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