Protocol for a Randomized Controlled Trial on the Development and Effectiveness of an Educational Mobile Application Using an Integrated Change Model to Prevent Atherosclerotic Cardiovascular Disease Risk Factors
-
Afsaneh Aein
,
Mahnaz Solhi
,
Ali Vashegani Farahani
,
Mohammad Aljasem
,
Farshid Alaeddini
,
Leila Janani
,
Negar Omidi
,
Mohammad Hossein Tagdisi
Abstract
Background: An effective approach to preventing cardiovascular issues is the use of mobile health applications to improve modifiable risk factors. This protocol for a randomized controlled trial aims to evaluate the development and effectiveness of an educational mobile app that employs an integrated change model to reduce risk factors for atherosclerotic cardiovascular disease (ASCVD) among individuals aged 20 to 69 years.
Methods: This study will be a parallel, randomized, single-blind clinical trial utilizing the randomized block design involving 430 participants. The participants will be divided into a control group receiving standard clinical care and an intervention group receiving standard clinical care along with app-based education, over approximately 6 months.
Conclusion: This application has been designed to enhance motivation, awareness, and positive habits to reduce risk factors in individuals at increased risk of ASCVD. Consequently, the results could improve cardiovascular health knowledge, manage biological risk factors, and modify cardiac behaviors through mobile applications. This research is expected to present a promising approach to utilizing mobile apps for managing cardiovascular health and contribute to the growing body of research on digital health interventions.
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5. Dall TM, Gallo PD, Chakrabarti R, West T, Semilla AP, Storm MV. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Aff (Millwood) 2013;32:2013-20.
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7. Wang W, Zhang H, Lopez V, Wu VX, Poo DC, Kowitlawakul Y. Improving awareness, knowledge and heart-related lifestyle of coronary heart disease among working population through a mHealth programme: study protocol. J Adv Nurs 2015;71:2200-2207.
8. Ullrich G, Dönmez A, Mahabadi AA, Bäuerle A, Knuschke R, Paldán K, Schnaubert L, Rammos C, Rassaf T, Julia Lortz. Effect of visual presentation of atherosclerotic carotid plaque on adherence to secondary preventive therapy using mHealth technologies (PreventiPlaque app): Study protocol for a randomized controlled trial. Heliyon 2023;9:e14052.
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11. Heshmati A, Moftian N, Rezaei-Hachesu P, Samad-Soltani T. Simple and Efficient Measurement of the User Experience in Health Information Systems: A Persian Version. Iran J Public Health 2021;50:217-218.
12. Heshmati A MN, Rezaei-Hachesu P, Samad-Soltani T. User Experience Questionnaire (UEQ) [updated 2018. Available from: https://www.ueq-online.org/ (23 August 2023).
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14. Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med 2011;2:106-16.
15. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175-191.
16. Patnode CD, Evans CV, Senger CA, Redmond N, Lin JS. Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA 2017;318:175-193.
17. Siopis G, Chey T, Allman-Farinelli M. A systematic review and meta-analysis of interventions for weight management using text messaging. J Hum Nutr Diet 2015;28 Suppl 2:1-15.
18. Liu S, Dunford SD, Leung YW, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Reducing blood pressure with Internet-based interventions: a meta-analysis. Can J Cardiol 2013;29:613-621.
19. Uhlig K, Patel K, Ip S, Kitsios GD, Balk EM. Self-measured blood pressure monitoring in the management of hypertension: a systematic review and meta-analysis. Ann Intern Med 2013;159:185-94.
20. Bort-Roig J, Gilson ND, Puig-Ribera A, Contreras RS, Trost SG. Measuring and influencing physical activity with smartphone technology: a systematic review. Sports Med 2014;44:671-686.
21. Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev 2016;4:CD006611.
22. Pal K, Eastwood SV, Michie S, Farmer AJ, Barnard ML, Peacock R, Wood B, Inniss JD, Murray E. Computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev 2013;2013:CD008776.
23. De Vries H. An integrated approach for understanding health behavior; the I-change model as an example. Psychol Behav Sci Int J 2017;2:555-585.
24. Moreau M, Gagnon MP, Boudreau F. Development of a fully automated, web-based, tailored intervention promoting regular physical activity among insufficiently active adults with type 2 diabetes: integrating the I-change model, self-determination theory, and motivational interviewing components. JMIR Res Protoc 2015;4:e25.
25. AlBurno H, Schneider F, de Vries H, Al Mohannadi D, Mercken L. Determinants of adherence to insulin and blood glucose monitoring among adolescents and young adults with type 1 diabetes in Qatar: a qualitative study. F1000Res 2024;11:907.
26. Lavoie A, Dubé V. Web-Based Interventions to Promote Healthy Lifestyles for Older Adults: Scoping Review. Interact J Med Res 2022;11:e37315.
27. Mohebbi B, Sabouri M, Tol A. Application of health education and promotion theory-based interventions on patients with cardiovascular disease: A systematic review. J Educ Health Promot 2021;10:236.
2. Tekkesin İ, Çinier G, Hayıroğlu M, Soluk Özdemir Y, Yıldırımtürk Ö, İnan D, Vatanoğlu EG, Parsova KE, Yüksel G, Durak F, Pay L. Rationale and design of lifestyle intervention using mobile technology in patients with high cardiovascular risk: A pragmatic randomized clinical trial. Turk Kardiyol Dern Ars 2020;48:149-157.
3. Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Muñoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2019;140:e596-e646.
4. Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Bäck M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed) 2022;75:429.
5. Dall TM, Gallo PD, Chakrabarti R, West T, Semilla AP, Storm MV. An aging population and growing disease burden will require a large and specialized health care workforce by 2025. Health Aff (Millwood) 2013;32:2013-20.
6. Tundjungsari V, Sofro ASM, Yugaswara H, Putra ATD. Development of mobile health application for cardiovascular disease prevention. JACSA 2018;9:543-550.
7. Wang W, Zhang H, Lopez V, Wu VX, Poo DC, Kowitlawakul Y. Improving awareness, knowledge and heart-related lifestyle of coronary heart disease among working population through a mHealth programme: study protocol. J Adv Nurs 2015;71:2200-2207.
8. Ullrich G, Dönmez A, Mahabadi AA, Bäuerle A, Knuschke R, Paldán K, Schnaubert L, Rammos C, Rassaf T, Julia Lortz. Effect of visual presentation of atherosclerotic carotid plaque on adherence to secondary preventive therapy using mHealth technologies (PreventiPlaque app): Study protocol for a randomized controlled trial. Heliyon 2023;9:e14052.
9. SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J 2021;42:2439-2454.
10. Poorhosseini H, Abbasi SH. The Tehran Heart Center. Eur Heart J 2018;39:2695-2696.
11. Heshmati A, Moftian N, Rezaei-Hachesu P, Samad-Soltani T. Simple and Efficient Measurement of the User Experience in Health Information Systems: A Persian Version. Iran J Public Health 2021;50:217-218.
12. Heshmati A MN, Rezaei-Hachesu P, Samad-Soltani T. User Experience Questionnaire (UEQ) [updated 2018. Available from: https://www.ueq-online.org/ (23 August 2023).
13. World Health Organization. Noncommunicable Diseases and Mental Health Cluster. (2005). WHO STEPS surveillance manual: the WHO STEPwise approach to chronic disease risk factor surveillance / Noncommunicable Diseases and Mental Health, World Health Organization. World Health Organization. https://iris.who.int/handle/10665/43376 (23 August 2023).
14. Vasheghani-Farahani A, Tahmasbi M, Asheri H, Ashraf H, Nedjat S, Kordi R. The Persian, last 7-day, long form of the International Physical Activity Questionnaire: translation and validation study. Asian J Sports Med 2011;2:106-16.
15. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175-191.
16. Patnode CD, Evans CV, Senger CA, Redmond N, Lin JS. Behavioral Counseling to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults Without Known Cardiovascular Disease Risk Factors: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA 2017;318:175-193.
17. Siopis G, Chey T, Allman-Farinelli M. A systematic review and meta-analysis of interventions for weight management using text messaging. J Hum Nutr Diet 2015;28 Suppl 2:1-15.
18. Liu S, Dunford SD, Leung YW, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Reducing blood pressure with Internet-based interventions: a meta-analysis. Can J Cardiol 2013;29:613-621.
19. Uhlig K, Patel K, Ip S, Kitsios GD, Balk EM. Self-measured blood pressure monitoring in the management of hypertension: a systematic review and meta-analysis. Ann Intern Med 2013;159:185-94.
20. Bort-Roig J, Gilson ND, Puig-Ribera A, Contreras RS, Trost SG. Measuring and influencing physical activity with smartphone technology: a systematic review. Sports Med 2014;44:671-686.
21. Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev 2016;4:CD006611.
22. Pal K, Eastwood SV, Michie S, Farmer AJ, Barnard ML, Peacock R, Wood B, Inniss JD, Murray E. Computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev 2013;2013:CD008776.
23. De Vries H. An integrated approach for understanding health behavior; the I-change model as an example. Psychol Behav Sci Int J 2017;2:555-585.
24. Moreau M, Gagnon MP, Boudreau F. Development of a fully automated, web-based, tailored intervention promoting regular physical activity among insufficiently active adults with type 2 diabetes: integrating the I-change model, self-determination theory, and motivational interviewing components. JMIR Res Protoc 2015;4:e25.
25. AlBurno H, Schneider F, de Vries H, Al Mohannadi D, Mercken L. Determinants of adherence to insulin and blood glucose monitoring among adolescents and young adults with type 1 diabetes in Qatar: a qualitative study. F1000Res 2024;11:907.
26. Lavoie A, Dubé V. Web-Based Interventions to Promote Healthy Lifestyles for Older Adults: Scoping Review. Interact J Med Res 2022;11:e37315.
27. Mohebbi B, Sabouri M, Tol A. Application of health education and promotion theory-based interventions on patients with cardiovascular disease: A systematic review. J Educ Health Promot 2021;10:236.
| Files | ||
| Issue | Vol 19 No 3 (2024): J Teh Univ Heart Ctr | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/jthc.v19i3.16860 | |
| Keywords | ||
| Atherosclerotic Education Mobile app Cardiovascular disease Prevention Risk factor | ||
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Aein A, Solhi M, Vashegani Farahani A, Aljasem M, Alaeddini F, Janani L, Omidi N, Tagdisi MH. Protocol for a Randomized Controlled Trial on the Development and Effectiveness of an Educational Mobile Application Using an Integrated Change Model to Prevent Atherosclerotic Cardiovascular Disease Risk Factors. J Tehran Heart Cent. 2024;19(3):170-183.
