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 in | BMJ open Vol. 10; no. 8; p. e034723 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
England
British Medical Journal Publishing Group
20.08.2020
BMJ Publishing Group LTD BMJ Publishing Group |
Series | Protocol |
Subjects | |
Online Access | Get full text |
ISSN | 2044-6055 2044-6055 |
DOI | 10.1136/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. |
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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 |
AuthorAffiliation_xml | – name: 6 Department of Biostatistics and Bioinformatics , Duke University , Durham , North Carolina , USA – name: 7 Computer Science , University of Toronto , Toronto , Ontario , Canada – name: 4 Centre for Quantitative Medicine , Duke-National University of Singapore Medical School , Singapore – name: 5 Department of Statistics and Applied Probability , National University of Singapore , Singapore – name: 1 School of Social Welfare , University of California Berkeley , Berkeley , California , USA – name: 3 Microsoft Research , Herzeliya , Israel – name: 2 UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco , Zuckerberg San Francisco General Hospital , San Francisco , California , USA |
Author_xml | – sequence: 1 givenname: Adrian surname: Aguilera fullname: Aguilera, Adrian organization: UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA – sequence: 2 givenname: Caroline A orcidid: 0000-0003-0692-2244 surname: Figueroa fullname: Figueroa, Caroline A email: c.a.figueroa@berkeley.edu organization: School of Social Welfare, University of California Berkeley, Berkeley, California, USA – sequence: 3 givenname: Rosa surname: Hernandez-Ramos fullname: Hernandez-Ramos, Rosa organization: School of Social Welfare, University of California Berkeley, Berkeley, California, USA – sequence: 4 givenname: Urmimala orcidid: 0000-0003-4213-4405 surname: Sarkar fullname: Sarkar, Urmimala organization: UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA – sequence: 5 givenname: Anupama surname: Cemballi fullname: Cemballi, Anupama organization: UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA – sequence: 6 givenname: Laura surname: Gomez-Pathak fullname: Gomez-Pathak, Laura organization: School of Social Welfare, University of California Berkeley, Berkeley, California, USA – sequence: 7 givenname: Jose surname: Miramontes fullname: Miramontes, Jose organization: UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA – sequence: 8 givenname: Elad surname: Yom-Tov fullname: Yom-Tov, Elad organization: Microsoft Research, Herzeliya, Israel – sequence: 9 givenname: Bibhas surname: Chakraborty fullname: Chakraborty, Bibhas organization: Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA – sequence: 10 givenname: Xiaoxi orcidid: 0000-0003-3291-1637 surname: Yan fullname: Yan, Xiaoxi organization: Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore – sequence: 11 givenname: Jing surname: Xu fullname: Xu, Jing organization: Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore – sequence: 12 givenname: Arghavan surname: Modiri fullname: Modiri, Arghavan organization: Computer Science, University of Toronto, Toronto, Ontario, Canada – sequence: 13 givenname: Jai surname: Aggarwal fullname: Aggarwal, Jai organization: Computer Science, University of Toronto, Toronto, Ontario, Canada – sequence: 14 givenname: Joseph surname: Jay Williams fullname: Jay Williams, Joseph organization: Computer Science, University of Toronto, Toronto, Ontario, Canada – sequence: 15 givenname: Courtney R surname: Lyles fullname: Lyles, Courtney R organization: UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/32819981$$D View this record in MEDLINE/PubMed |
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Copyright | 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. 2023 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. http://creativecommons.org/licenses/by-nc/4.0/ 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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 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. 2020 |
Copyright_xml | – notice: 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. – notice: 2023 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. http://creativecommons.org/licenses/by-nc/4.0/ 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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: 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. 2020 |
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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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Notes | Protocol ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 AA and CAF are joint first authors. |
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PublicationDate | 2020-08-20 |
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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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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 |
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