mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study

IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separ...

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Published inBMJ open Vol. 10; no. 8; p. e034723
Main Authors Aguilera, Adrian, Figueroa, Caroline A, Hernandez-Ramos, Rosa, Sarkar, Urmimala, Cemballi, Anupama, Gomez-Pathak, Laura, Miramontes, Jose, Yom-Tov, Elad, Chakraborty, Bibhas, Yan, Xiaoxi, Xu, Jing, Modiri, Arghavan, Aggarwal, Jai, Jay Williams, Joseph, Lyles, Courtney R
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 20.08.2020
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesProtocol
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Online AccessGet full text
ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2019-034723

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Abstract IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual’s behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18–75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration numberNCT03490253; pre-results.
AbstractList Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.INTRODUCTIONDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.METHODS AND ANALYSISIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.ETHICS AND DISSEMINATIONThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.NCT03490253; pre-results.TRIAL REGISTRATION NUMBERNCT03490253; pre-results.
Introduction Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual’s behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysis In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18–75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and dissemination The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration number NCT03490253; pre-results.
IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual’s behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18–75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration numberNCT03490253; pre-results.
Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention. In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up. The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings. NCT03490253; pre-results.
Author Sarkar, Urmimala
Gomez-Pathak, Laura
Cemballi, Anupama
Miramontes, Jose
Aguilera, Adrian
Yom-Tov, Elad
Modiri, Arghavan
Aggarwal, Jai
Yan, Xiaoxi
Xu, Jing
Hernandez-Ramos, Rosa
Chakraborty, Bibhas
Figueroa, Caroline A
Lyles, Courtney R
Jay Williams, Joseph
AuthorAffiliation 6 Department of Biostatistics and Bioinformatics , Duke University , Durham , North Carolina , USA
5 Department of Statistics and Applied Probability , National University of Singapore , Singapore
1 School of Social Welfare , University of California Berkeley , Berkeley , California , USA
7 Computer Science , University of Toronto , Toronto , Ontario , Canada
2 UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco , Zuckerberg San Francisco General Hospital , San Francisco , California , USA
3 Microsoft Research , Herzeliya , Israel
4 Centre for Quantitative Medicine , Duke-National University of Singapore Medical School , Singapore
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/32819981$$D View this record in MEDLINE/PubMed
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Keywords telemedicine
health informatics
depression & mood disorders
diabetes & endocrinology
Language English
License This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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– reference: 37433738 - BMJ Open. 2023 Jul 11;13(7):e034723corr1
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Snippet IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic...
Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients....
Introduction Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic...
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pubmedcentral
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pubmed
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SourceType Open Website
Open Access Repository
Aggregation Database
Index Database
Enrichment Source
Publisher
StartPage e034723
SubjectTerms Adaptive learning
Adolescent
Adult
Aged
Behavior
Clinical trials
depression & mood disorders
Depression - epidemiology
Design
Diabetes
diabetes & endocrinology
Diabetes Mellitus - epidemiology
Diabetes Mellitus - therapy
Ethnicity
Exercise
Health care access
health informatics
Humans
Hypotheses
Intervention
Low income groups
Machine Learning
Mental depression
Mental Health
Middle Aged
Minority & ethnic groups
Minority Groups
Mobile Applications
Patients
Portable computers
Primary care
Randomized Controlled Trials as Topic
San Francisco
Smartphones
Telemedicine
Text messaging
Young Adult
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Title mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study
URI https://bmjopen.bmj.com/content/10/8/e034723.full
https://www.ncbi.nlm.nih.gov/pubmed/32819981
https://www.proquest.com/docview/2436086080
https://www.proquest.com/docview/2436395628
https://pubmed.ncbi.nlm.nih.gov/PMC7443305
https://doaj.org/article/8dbbcf0f9d91405687add678da8f20de
Volume 10
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