Mobile application intervention to promote self-management in insulin-requiring type 1 and type 2 diabetes individuals: protocol for a mixed methods study and non-blinded randomized controlled trial

References

• Clark M . Diabetes self-management education: a review of published studies. Prim Care Diabetes . 2008;2(3):113–120. doi:10.1016/j.pcd.2008.04.004 18779034
   PubMedGoogle Scholar
• Renders CM , Valk GD , Griffin SJ , Wagner EH , van JT E , Assendelft WJJ . Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care . 2001;24(10):1821–1833.11574449
   PubMed Web of Science ®Google Scholar
• Powers MA , Bardsley J , Cypress M , et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American association of diabetes educators, and the academy of nutrition and dietetics. J Acad Nutr Diet . 2015;115(8):1323–1334. doi:10.1016/j.jand.2015.05.012 26054423
   PubMed Web of Science ®Google Scholar
• Association Diabetes Association. Standards of medical care in diabetes—2016 abridged for primary care providers. Clin Diabetes . 2016;34(1):3. doi:10.2337/diaclin.34.1.3 26807004
   PubMedGoogle Scholar
• Colagiuri R , Girgis S , Eigenmann C , Gomez M , Griffiths R . National Evidenced Based Guideline for Patient Education in Type 2 Diabetes . Canberra:Diabetes Australia and the NHMRC;2009 Available from:: http://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/b9b8789d-c7ba-473d-bd49-0b7d793a0835.pdf.
   Google Scholar
• Coyle ME , Francis K , Chapman Y . Self-management activities in diabetes care: a systematic review. Aust Health Rev . 2013;37(4):513–522. doi:10.1071/AH13060 24018058
   PubMed Web of Science ®Google Scholar
• Shrivastava SR , Shrivastava PS , Ramasamy J . Role of self-care in management of diabetes mellitus. J Diabetes Metab Disord . 2013;12(1):14. doi:10.1186/2251-6581-12-14 23497559
   PubMedGoogle Scholar
• Duncan I , Birkmeyer C , Coughlin S , Qijuan L , Sheer D , Boren S . Assessing the value of diabetes education. Diabetes Educ . 2009;35(5):752–760. doi:10.1177/0145721709343609 19783766
   PubMed Web of Science ®Google Scholar
• Norris SL , Lau J , Smith SJ , Schmid C , Engelgau MM . Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care . 2002;25(7):1159–1171.12087014
   PubMed Web of Science ®Google Scholar
• Steinsbekk A , Rygg L , Lisulo M , Rise MB , Fretheim A . Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. BMC Health Serv Res . 2012;12(1):213. doi:10.1186/1472-6963-12-213 22824531
   PubMed Web of Science ®Google Scholar
• Peyrot M , Rubin RR , Funnell MM , Siminerio LM . Access to diabetes self-management education. Diabetes Educ . 2009;35(2):246–263. doi:10.1177/0145721708329546 19208816
   PubMed Web of Science ®Google Scholar
• Funnell MM , Brown TL , Childs BP , et al. National standards for diabetes self-management education. Diabetes Care . 2009;32(Suppl 1):S87–94. doi:10.2337/dc09-S087 19118294
   PubMedGoogle Scholar
• Nagelkerk J , Reick K , Meengs L . Perceived barriers and effective strategies to diabetes self‐management. J Adv Nurs . 2006;54(2):151–158. doi:10.1111/j.1365-2648.2006.03799.x 16553701
   PubMed Web of Science ®Google Scholar
• Clement S . Diabetes self-management education. Diabetes Care . 1995;18(8):1204–1214.7587866
   PubMed Web of Science ®Google Scholar
• Mickan S , Tilson JK , Atherton H , Roberts NW , Heneghan C . Evidence of effectiveness of health care professionals using handheld computers: a scoping review of systematic reviews. J Med Internet Res . 2013;15(10). doi:10.2196/jmir.2530
   Web of Science ®Google Scholar
• Fogg B . Persuasive Technology: Using Computers to Change What We Think and Do . 1st ed. San Francisco, California: Interactive Technologies; 2002.
   Google Scholar
• Matthews J , Win KT , Oinas-Kukkonen H , Freeman M . Persuasive technology in mobile applications promoting physical activity: a systematic review. J Med Syst . 2016;40(3):72. doi:10.1007/s10916-015-0425-x 26748792
   PubMed Web of Science ®Google Scholar
• Goyal S , Cafazzo JA . Mobile phone health apps for diabetes management: current evidence and future developments. Qjm . 2013;106(12):1067–1069. doi:10.1093/qjmed/hct203 24106313
   PubMed Web of Science ®Google Scholar
• Chomutare T , Fernadez-Luque L , Arsand E , Hartvigsen G . Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res . 2011;13(3). doi:10.2196/jmir.1874
   Web of Science ®Google Scholar
• Martínez-Pérez B , De La Torre-Díez I , López-Coronado M . Mobile health applications for the most prevalent conditions by the World Health Organization: review and analysis. J Med Internet Res . 2013;15(6). doi:10.2196/jmir.2600
   Web of Science ®Google Scholar
• Boren SA , Leo GD , Chanetsa F , Donaldson J , Krishna S , Balas EA . Evaluation of a diabetes education call center intervention. Telemed J E Health . 2006;12(4):457–465. doi:10.1089/tmj.2006.12.457 16942418
   PubMed Web of Science ®Google Scholar
• Déglise C , Suggs LS , Odermatt P . Short message service (SMS) applications for disease prevention in developing countries. J Med Internet Res . 2012;14(1). doi:10.2196/jmir.1823
   Web of Science ®Google Scholar
• Vervloet M , Linn AJ , van Weert JCM , de Bakke DH , Bouvy ML , van Dijk L . The effectiveness of interventions using electronic reminders to improve adherence to chronic medication: a systematic review of the literature. J Am Med Inform Assoc . 2012;19(5):696–704. doi:10.1136/amiajnl-2011-000748 22534082
   PubMed Web of Science ®Google Scholar
• Bonoto BC , de Araujo VE , Godoi IP , et al. Efficacy of mobile apps to support the care of patients with diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. JMIR Mhealth Uhealth . 2017;5(3). doi:10.2196/mhealth.6309
   Web of Science ®Google Scholar
• Catherine HY , Parsons JA , Mamdani M , et al. A web-based intervention to support self-management of patients with type 2 diabetes mellitus: effect on self-efficacy, self-care and diabetes distress. BMC Med Inform Decis Mak . 2014;14:117. doi:10.1186/s12911-014-0117-3 25495847
   PubMed Web of Science ®Google Scholar
• Steele R , Amanda LO , Secombe C , Wong YK . Elderly persons’ perception and acceptance of using wireless sensor networks to assist healthcare. Int J Med Inform . 2009;78(12):788–801. doi:10.1016/j.ijmedinf.2009.08.001 19717335
   PubMed Web of Science ®Google Scholar
• Istepanian RS , Zitouni K , Harry D , et al. Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes. J Telemed Telecare . 2009;15(3):125–128. doi:10.1258/jtt.2009.003006 19364893
   PubMed Web of Science ®Google Scholar
• Holmen H , Torbornsen A , Wahl AK , et al. A mobile health intervention for self-management and lifestyle change for persons with type 2 diabetes, part 2: one-year results from the Norwegian randomized controlled trial RENEWING HEALTH. JMIR Mhealth Uhealth . 2014;2:4. doi:10.2196/mhealth.3882
   Web of Science ®Google Scholar
• Kirwan M , Vandelanotte C , Fenning A , Duncan MJ . Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Internet Res . 2013;15:11. doi:10.2196/jmir.2588
   Web of Science ®Google Scholar
• Demidowich AP , Lu K , Tamier R , Bloomgarden Z . An evaluation of diabetes self-management applications for Android smartphones. J Telemed Telecare . 2012;18(4):235–238. doi:10.1258/jtt.2012.111002 22604278
   PubMed Web of Science ®Google Scholar
• Mallenius S , Rossi M , Tuunainen VK . Factors affecting the adoption and use of mobile devices and services by elderly people–results from a pilot study. 6th Annu Global Mobility Roundtable . 2007;31:12 Available from: file:///C:/Users/jc447532/AppData/Local/Temp/Temp1_97c9c58b82667b842a9dd9c10d54e19ade8b.html.zip/97c9c58b82667b842a9dd9c10d54e19ade8b.html
   Google Scholar
• Holzinger A , Searle G , Nischelwitzer A On some aspects of improving mobile applications for the elderly. Universal access in human-computer interaction. Coping with diversity. 12th International Conference on Human-computer Interaction (HCI); Las Vegas, NV. 2007: 4554. doi:10.1007/978-3-540-73279-2_103
   Google Scholar
• Jahns R Today’s diabetes apps are far away from meeting the seven best practice standard. research2guidance; 2014 Available from: https://research2guidance.com/todays-diabetes-apps-are-far-away-from-meeting-the-seven-best-practice-standards-2. Accessed 20 1, 2018
   Google Scholar
• Holmen H , Whal AK , Smastuen MC , Ribu L . Tailored communication within mobile apps for diabetes self-management: A systematic review. J Med Internet Res . 2017;19(6). doi:10.2196/jmir.7045
   Web of Science ®Google Scholar
• Izahar S , Lean Q , AbdulHameed M , et al. Content analysis of mobile health applications on diabetes mellitus. Fron Endocrinol . 2017;8:318. doi:10.3389/fendo.2017.00318
   PubMed Web of Science ®Google Scholar
• El-Gayar O , Timsina P , Nawar N , Eid W .Mobile applications for diabetes self-management: status and potential. J Diabetes Sci Technol . 2013;7(1):247–262. doi:10.1177/193229681300700130 23439183
   PubMedGoogle Scholar
• Australian Government Department of Health. Australian national diabetes strategy 2016-2020. ISBN: 978-1-76007-218-6; 2015 Available from: http://www.health.gov.au/internet/main/publishing.nsf/content/3AF935DA210DA043CA257EFB000D0C03/$File/Australian%20National%20Diabetes%20Strategy%202016-2020.pdf. Accessed 19 6 2017.
   Google Scholar
• Wisdom J , Creswell J . Mixed Methods: Integrating Quantitative and Qualitative Data Collection and Analysis while Studying Patient-Centered Medical Home Models . Rockville, MD: Agency for Healthcare Research and Quality; 2013.
   Google Scholar
• Faul F , Erdgfelder E , Lang A , Buchner AG . G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods . 2007;39(2):175–191.17695343
   PubMed Web of Science ®Google Scholar
• Mbuagbaw L , Aronson R , Walker A , Brown RE , Orzech N . The LMC Skills, Confidence & Preparedness Index (SCPI): development and evaluation of a novel tool for assessing self-management in patients with diabetes. Health Qual Life Outcomes . 2017;15(1):27. doi:10.1186/s12955-017-0606-z 28143548
   PubMed Web of Science ®Google Scholar
• Guest G , Bunce A , Johnson L . How many interviews are enough? An experiment with data saturation and variability. Field Methods . 2006;18(1):59–82. doi:10.1177/1525822X05279903
   Web of Science ®Google Scholar
• Pallant J . SPSS Survival Manual: A Step by Tep Guide to Data Analysis Using IBM SPSS . 6th ed. Sydney, Australia: Allen&Unwin; 2016.
   Google Scholar
• Braun V , Clarke V . Using thematic analysis in psychology. Qual Res Psychol . 2006;3(2):77–101. doi:10.1191/1478088706qp063oa
   Google Scholar
• Stoyanov SR , Hides L , Kavanagh DJ , Zelenko O , Tjondronegoro D , Mani M . Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth . 2015;3(1):e27. doi:10.2196/mhealth.3949 25760773
   PubMed Web of Science ®Google Scholar
• Sibbald B , Roland M . Understanding controlled trials. Why are randomised controlled trials important? BMJ: Br Med J . 1998;316(7126):201. doi:10.1136/bmj.316.7126.201 9468688
   PubMed Web of Science ®Google Scholar
• Crowther CA , Hiller JE , Moss JR , McPhee AJ , Jeffries WS , Robinson JS . Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med . 2005;352(24):2477–2486. doi:10.1056/NEJMoa042973 15951574
   PubMed Web of Science ®Google Scholar
• Australian Institute of Health and Welfare. How does Australia’s health system work? In: Australia’s Health 2016. Australia’s Health Series No.15. Cat. No. AUS 199 . Canberra: AIHW 2016: 5–7. Available from: https://www.aihw.gov.au/getmedia/f2ae1191-bbf2-47b6-a9d4-1b2ca65553a1/ah16-2-1-how-does-australias-health-system-work.pdf.aspx. Accessed 20 9 2018.
   Google Scholar
• Australian Diabetes Education Association. The role of credentialled diabetes educators and accredited practising dietician in the delivery of diabetes self-management and nutrition services for people with diabetes; 2015 Available from: https://daa.asn.au/wp-content/uploads/2015/05/ADEA-and-DAA-Joint-Statement-FINAL.pdf. Accessed 20 9 2018.
   Google Scholar
• Diabetes Australia. National Diabetes Service Scheme; 2015 Available from: https://www.diabetesaustralia.com.au/ndss. Accessed on 3 4 2018
   Google Scholar
• Stiles-Shields C. , Montague E , Lattie EG , Kwasny MJ , Mohr DC . What might get in the way: barriers to the use of apps for depression. Digit Health . 2017;3:2055207617713827. doi:10.1177/2055207617729937 29942605
   PubMedGoogle Scholar
• Greevy R , Lu B , Silber JH , Rosenbaum P . Optimal multivariate matching before randomization. Biostatistics . 2004;5(2):263–275. doi:10.1093/biostatistics/5.2.263 15054030
   PubMed Web of Science ®Google Scholar
• Haas L , Maryniuk M , Beck J , et al. National standards for diabetes self-management education and support. Diabetes Educ . 2012;38(5):619–629. doi:10.1177/0145721712455997 22996411
   PubMed Web of Science ®Google Scholar
• Friedman L , Furberg C , DeMets D . Fundamentals of Clinical Trials . 5th ed. New York: Springer; 2015.
   Google Scholar
• Rossi MC , Nicolucci A , Lucisano G , et al. Impact of the “Diabetes Interactive Diary” telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes. Diabetes Technol Ther . 2013;15(8):670–679. doi:10.1089/dia.2013.0021 23844569
   PubMed Web of Science ®Google Scholar
• Ribu L , Olmen H , Torbjornsen A , et al. Low-intensity self-management intervention for persons with type 2 diabetes using a mobile phone-based diabetes diary, with and without health counseling and motivational interviewing: protocol for a randomized controlled trial. JMIR Res Protoc . 2013;2(2). doi:10.2196/resprot.2768
   Google Scholar
• McCoy CE . Understanding the intention-to-treat principle in randomized controlled trials. West J Emerg Med . 2017;18(6):1075. doi:10.5811/westjem.2016.10.32233 29085540
   PubMed Web of Science ®Google Scholar
• Lin D , Fleming T , De Gruttola V . Estimating the proportion of treatment effect explained by a surrogate marker. Stat Med . 1997;16(13):1515–1527.9249922
   PubMed Web of Science ®Google Scholar
• Drummond MF , Sculpher MJ , Claxto K , Stoddart GL , Torrance GW . Methods for the Economic Evaluation of Health Care Programmes . 4th ed. Newyork: Oxford University; 2015.
   Google Scholar
• National Health and Medical Research Council/Australian Research Council and University Australia. Australian code for the responsible conduct of research; 2007 Available from: https://www.nhmrc.gov.au/guidelines-publications/r39. Accessed 19 2, 2018.
   Google Scholar
• Årsand E , Demiris G . User-centered methods for designing patient-centric self-help tools. Inform Health Soc Care . 2008;33(3):158–169. doi:10.1080/17538150802457562 18850399
   PubMed Web of Science ®Google Scholar
• McCurdie T , Taneva S , Casselman M , Yeung M , McDaniel C , Ho W , Cafazzo J . mHealth consumer apps: the case for user-centered design. Biomed Instrum Technol . 2012;46(s2):49–56. doi:10.2345/0899-8205-46.1.49 22239360
   PubMedGoogle Scholar
• Whitehead L , Seaton P . The effectiveness of self-management mobile phone and tablet apps in long-term condition management: a systematic review. J Med Internet Res . 2016;18(5). doi:10.2196/jmir.4883
   Web of Science ®Google Scholar
• Goyal S , Morita P , Lewis GF , Yu C , Seto E , Cefazzo JA . The systematic design of a behavioural mobile health application for the self-management of type 2 diabetes. Can J Diabetes . 2016;40(1):95–104. doi:10.1016/j.jcjd.2015.06.007 26455762
   PubMed Web of Science ®Google Scholar
• Torbjørnsen A , Jenum AK , Smastuen MC , et al. A low-intensity mobile health intervention with and without health counseling for persons with type 2 diabetes, part 1: baseline and short-term results from a randomized controlled trial in the Norwegian part of RENEWING HEALTH. JMIR Mhealth Uhealth . 2014;2(4). doi:10.2196/mhealth.3535
   Web of Science ®Google Scholar
• Pereira K , Beth P , Constance J , Allison V . Internet delivered diabetes self-management education: a review. Diabetes Technol Ther . 2015;17(1):55–63. doi:10.1089/dia.2014.0155 25238257
   PubMed Web of Science ®Google Scholar
• Greenwood DA , Gee PM , Fatkin KJ , Peeples M . A systematic review of reviews evaluating technology-enabled diabetes self-management education and support. J Diabetes Sci Technol . 2017;11(5):1015–1027. doi:10.1177/1932296817713506 28560898
   PubMedGoogle Scholar
• Kitsiou S , Pare G , Jaana M , Gerber B . Effectiveness of mHealth interventions for patients with diabetes: an overview of systematic reviews. PLoS One . 2017;12(3):e0173160. doi:10.1371/journal.pone.0173160 28249025
   PubMed Web of Science ®Google Scholar
• Collins G , Mughal S , Barnett AH , Fitzgerald J , Lioyd CE . Modification and validation of the revised diabetes knowledge scale. Diabet Med . 2011;28(3):306–310. doi:10.1111/j.1464-5491.2010.03190.x 21309839
   PubMed Web of Science ®Google Scholar
• Al-Qazaz H , Hassali MA , Shafie AA , Sulaiman SA , Sundram S . The 14-item michigan diabetes knowledge test: translation and validation study of the Malaysian version. Practical Diabetes Int . 2010;27(6):238–241a. doi:10.1002/pdi.1495
   Google Scholar
• Schmitt A , Gahr A , Hermanns N , Kulzer B , Huber J , Haak T . The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcome . 2013;11(1):138. doi:10.1186/1477-7525-11-138
   PubMed Web of Science ®Google Scholar
• Culig J , Leppée M . from morisky to hill-bone; self-reports scales for measuring adherence to medication. Coll Antropol . 2014;38(1):55–62.
   PubMedGoogle Scholar
• Richardson J , Iezzi A , Khan MA et al. Validity and reliability of the Assessment of Quality of Life (AQoL-8D) multi-attribute utility instrument. Patient . 2014;7(1):85–96. doi:10.1007/s40271-013-0036-x 24271592
   PubMedGoogle Scholar