Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study): Protocol for a Randomized Controlled Trial
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Abstract
BACKGROUND: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies-mobile phones and the internet-to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk. Interventions through text messaging and electronic BP monitoring present divergent results. OBJECTIVE: This trial evaluates the effectiveness of interventions-personalized messages and telemonitoring of BP-to reduce systolic BP and improve lifestyle compared to the usual care of patients with hypertension (control group). METHODS: This factorial randomized controlled trial enrolls individuals aged 30 to 75 years who have a mobile phone and internet access with the diagnosis of hypertension under drug treatment with up to 2 medications and uncontrolled BP. Eligible participants should have both increased office BP and 24-hour BP with ambulatory BP monitoring. Participants with severe hypertension (systolic BP ≥180 or diastolic BP ≥110 mm Hg), life threatening conditions, low life expectancy, recent major cardiovascular event (last 6 months), other indications for the use of antihypertensive medication, diagnosis of secondary hypertension, pregnant or lactating women, or those unable to understand the interventions are excluded. Participants are randomly allocate to 1 of 4 experimental arms: (1) Telemonitoring of blood pressure (TELEM) group: receives an automatic oscillometric device to measure BP, (2) telemonitoring by text message (TELEMEV) group: receives personalized, standardized text messages to stimulate lifestyle changes and adhere with BP-lowering medication, (3) TELEM-TELEMEV group: receives both interventions, and (4) control group: receives usual clinical treatment (UCT). Data collection is performed in a clinical research center located in a referent hospital. The primary outcomes are reduction of systolic BP assessed by 24-hour ambulatory BP monitoring (primary outcome) and change of lifestyle (based on dietary approaches to stop hypertension (DASH)-type diet, sodium restriction, weight loss or control, increase of physical activity). RESULTS: This study was funded by two Brazilian agencies: the National Council for Scientific and Technological Development and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul. Enrollment was completed at the end of 2017 (N=231), the follow-up is ongoing, and data analysis is expected to begin in early 2019. A reduction of 24-hour systolic BP of approximately 8.8 [SD 13.1] mm Hg for participants in the BP monitoring group versus 3.4 [SD 11.6] mm Hg in the UCT group is expected. A similar reduction in the text messaging group is expected. CONCLUSIONS: The use of mobile technologies connected to the internet through mobile phones promotes time optimization, cost reduction, and better use of public health resources. However, it has not been established whether simple interventions such as text messaging are superior to electronic BP monitoring and whether both outperform conventional counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT03005470; https://clinicaltrials.gov/ct2/show/NCT03005470 (Archived by WebCite at http://www.webcitation.org/70AoANESu). Plataforma Brasil CAAE 31423214.0.0000.5327. REGISTERED REPORT IDENTIFIER: RR1-10.2196/9619.
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The TIM study is registered at ClinicalTrials.gov with ID NCT03005470.
“The TIM study is registered at www.clinicaltrials.gov with the ID number: NCT03005470 and details have been published [18].”
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Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Collins, K. J., Dennison Himmelfarb, C., DePalma, S. M., Gidding, S., Jamerson, K. A., Jones, D. W., et al. (2018) · Hypertension · doi:10.1161/hyp.0000000000000065 · Cited by 7,391 · see citing works
Mills, K. T., Bundy, J. D., Kelly, T. N., Reed, J. E., Kearney, P. M., Reynolds, K., Chen, J., & He, J. (2016) · Circulation · doi:10.1161/circulationaha.115.018912 · Cited by 3,531 · see citing works
Zhou, B., Bentham, J., Di Cesare, M., Bixby, H., Danaei, G., Cowan, M. J., Paciorek, C. J., Singh, G., Hajifathalian, K., Bennett, J. E., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(16)31919-5 · Cited by 2,579 · see citing works
Self-citationRandom allocation software for parallel group randomized trials
Saghaei, M. (2004) · BMC Medical Research Methodology · doi:10.1186/1471-2288-4-26 · Cited by 793 · see citing works
Chow, C. K., Redfern, J., Hillis, G. S., Thakkar, J., Santo, K., Hackett, M. L., Jan, S., Graves, N., de Keizer, L., Barry, T., et al. (2015) · JAMA · doi:10.1001/jama.2015.10945 · Cited by 676 · see citing works
Tucker, K. L., Sheppard, J. P., Stevens, R., Bosworth, H. B., Bove, A., Bray, E. P., Earle, K., George, J., Godwin, M., Green, B. B., et al. (2017) · PLOS Medicine · doi:10.1371/journal.pmed.1002389 · Cited by 658 · see citing works
Margolis, K. L., Asche, S. E., Bergdall, A. R., Dehmer, S. P., Groen, S. E., Kadrmas, H. M., Kerby, T. J., Klotzle, K. J., Maciosek, M. V., Michels, R. D., et al. (2013) · JAMA · doi:10.1001/jama.2013.6549 · Cited by 591 · see citing works
Omboni, S., Gazzola, T., Carabelli, G., & Parati, G. (2013) · Journal of Hypertension · doi:10.1097/hjh.0b013e32835ca8dd · Cited by 313 · see citing works
Bobrow, K., Farmer, A. J., Springer, D., Shanyinde, M., Yu, L.-M., Brennan, T., Rayner, B., Namane, M., Steyn, K., Tarassenko, L., et al. (2016) · Circulation · doi:10.1161/circulationaha.115.017530 · Cited by 295 · see citing works
Mobile Health Devices as Tools for Worldwide Cardiovascular Risk Reduction and Disease Management
Piette, J. D., List, J. M., Rana, G., Townsend, W. A., Striplin, D., & Heisler, M. (2015) · Circulation · doi:10.1161/circulationaha.114.008723 · Cited by 223 · see citing works
Trends in Prevalence of Hypertension in Brazil: A Systematic Review with Meta-Analysis
Picon, R. V., Fuchs, F. D., Moreira, L. B., Riegel, G. R. C., & Fuchs, S. C. P. C. (2012) · PLoS ONE · doi:10.1371/journal.pone.0048255 · Cited by 206 · see citing works
Self-citationMcKinstry, B., Hanley, J., Wild, S., Pagliari, C., Paterson, M., Lewis, S., Sheikh, A., Krishan, A., Stoddart, A., & Padfield, P. (2013) · BMJ · doi:10.1136/bmj.f3030 · Cited by 199 · see citing works
Frederix, I., Hansen, D., Coninx, K., Vandervoort, P., Vandijck, D., Hens, N., Van Craenenbroeck, E., Van Driessche, N., & Dendale, P. (2015) · Journal of Medical Internet Research · doi:10.2196/jmir.4799 · Cited by 185 · see citing works
Adler, A. J., Martin, N., Mariani, J. A., Tajer, C. D., Owolabi, O. O., Free, C., Serrano, N. C., Casas, J. P., & Perel, P. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011851.pub2 · Cited by 143 · see citing works
Posadzki, P., Mastellos, N., Ryan, R. E., Gunn, L. H., Felix, L. M., Pappas, Y., Gagnon, M., Julious, S. A., Xiang, L., Oldenburg, B. F., et al. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009921.pub2 · Cited by 132 · see citing works
Picon, R. V., Fuchs, F. D., Moreira, L. B., et al. (2013) · American Journal of Hypertension · doi:10.1093/ajh/hps076 · Cited by 129 · see citing works
Self-citationAutomated Office Blood Pressure
Myers, M. G., & Godwin, M. S. (2012) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2011.09.004 · Cited by 79 · see citing works
DeCastro, M. L., Fuchs, F. D., COSTASANTOS, M., Maximiliano, P., Gus, M., BELTRAMIMOREIRA, L., & Ferreira, M. B. C. (2006) · American Journal of Hypertension · doi:10.1016/j.amjhyper.2005.11.009 · Cited by 76 · see citing works
Self-citationWetzels, G., Nelemans, P. J., Schouten, J., Dirksen, C. D., VANDERWEIJDEN, T., Stoffers, J., Janknegt, R., DELEEUW, P., & Prins, M. H. (2007) · American Journal of Hypertension · doi:10.1016/j.amjhyper.2006.07.018 · Cited by 63 · see citing works
Cook, A. J., Anderson, M. L., Catz, S. L., Fishman, P. A., Carlson, J., Johnson, R., Green, B. B., & Ralston, J. D. (2014) · Applied Clinical Informatics · doi:10.4338/aci-2013-10-ra-0079 · Cited by 59 · see citing works
Kim, J. Y., Wineinger, N. E., Taitel, M., Radin, J. M., Akinbosoye, O., Jiang, J., Nikzad, N., Orr, G., Topol, E., & Steinhubl, S. (2016) · Journal of Medical Internet Research · doi:10.2196/jmir.6371 · Cited by 37 · cited 1× · see citing works
“Results from previous trials have indicated the potential beneficial impact of self-monitoring programs [23], home blood pressure monitoring [5], and text messages [24], but these interventions have not been compared or assessed regarding other cardiovascular risk factors.”
BackgroundFuchs, S. C., Ferreira-da-silva, A. L., Moreira, L. B., Neyeloff, J. L., Fuchs, F. C., Gus, M., Wiehe, M., & Fuchs, F. D. (2012) · Journal of Hypertension · doi:10.1097/hjh.0b013e32834e5a4f · Cited by 36 · see citing works
Self-citationGodwin, M., Birtwhistle, R., Seguin, R., et al. (2009) · Family Practice · doi:10.1093/fampra/cmp075 · Cited by 12 · see citing works
Abraham, I. L., Camp, Y. P. M. V., Zapata, L. V., Denhaerynck, K., Sun, D. K., Vancayzeele, S., Brié, H., Aerts, A., Hermans, C., & MacDonald, K. (2013) · Journal of Clinical Hypertension · doi:10.1111/jch.12163 · Cited by 8 · see citing works
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David, C. N., Iochpe, C., Harzheim, E., Sesin, G. P., Gonçalves, M. R., Moreira, L. B., Fuchs, F. D., & Fuchs, S. C. (2023) · Healthcare · doi:10.3390/healthcare11081069 · Cited by 11 · see citing works
“gov with the ID number: NCT03005470 and details have been published [18].”
BackgroundSelf-citation
- Authors
- Fuchs, S. C., Harzheim, E., Iochpe, C., David, C. N. D., Gonçalves, M. R., Sesin, G. P., Costa, C. M., Moreira, L. B., & Fuchs, F. D.
- Affiliations
- Universidade Federal do Rio Grande do Sul (BR)
- ORCID
- Venue
- JMIR Research Protocols
- Publisher
- JMIR Publications Inc.
- Published
- 2018-08-07
- Volume
- 7
- Issue
- 8
- Pages
- e169
- ISSN
- 1929-0748 (ISSN-L)
- PMC
- PMC6104448
- OpenAlex
- W2802219370
- Cited by
- 4
- References
- 24
- Citations by year
- 2024: 1 · 2023: 1 · 2020: 2
- FWCI
- 0.76
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Research Protocols (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- Americanae (AECID Library) (submittedVersion, cc-by-nc-sa)
- Funders
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul (2274-2551/14-9)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- hypertension, blood pressure control, remote patient monitoring, text messaging, personalized messages, lifestyle intervention, ambulatory blood pressure monitoring, DASH diet, sodium restriction, weight loss, physical activity, medication adherence, older adults, adults, low- and middle-income countries, Brazil, cardiovascular risk reduction, factorial design, usual care comparison, oscillometric blood pressure devices, online intervention
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