Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study)
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BACKGROUND: Inadequate blood pressure control and poor adherence to treatment remain among the major limitations in the management of hypertensive patients, particularly of those at high risk of cardiovascular events. Preliminary evidence suggests that home blood pressure telemonitoring (HBPT) might help increasing the chance of achieving blood pressure targets and improve patient's therapeutic adherence. However, all these potential advantages of HBPT have not yet been fully investigated. METHODS/DESIGN: The purpose of this open label, parallel group, randomized, controlled study is to assess whether, in patients with high cardiovascular risk (treated or untreated essential arterial hypertension--both in the office and in ambulatory conditions over 24 h--and metabolic syndrome), long-term (48 weeks) blood pressure control is more effective when based on HBPT and on the feedback to patients by their doctor between visits, or when based exclusively on blood pressure determination during quarterly office visits (conventional management (CM)). A total of 252 patients will be enrolled and randomized to usual care (n = 84) or HBPT (n = 168). The primary study endpoint will be the rate of subjects achieving normal daytime ambulatory blood pressure targets (< 135/85 mmHg) 24 weeks and 48 weeks after randomization. In addition, the study will assess the psychological determinants of adherence and persistence to drug therapy, through specific psychological tests administered during the course of the study. Other secondary study endpoints will be related to the impact of HBPT on additional clinical and economic outcomes (number of additional medical visits, direct costs of patient management, number of antihypertensive drugs prescribed, level of cardiovascular risk, degree of target organ damage and rate of cardiovascular events, regression of the metabolic syndrome). DISCUSSION: The TELEBPMET Study will show whether HBPT is effective in improving blood pressure control and related medical and economic outcomes in hypertensive patients with metabolic syndrome. It will also provide a comprehensive understanding of the psychological determinants of medication adherence and blood pressure control of these patients. TRIAL REGISTRATION: Clinical Trials.gov: NCT01541566.
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A meta-analysis of 28 trials with more than 7000 participants revealed a significant modest positive effect of HBPM, isolated or associated with co-interventions, on medication adherence when measured objectively by pill count or electronic monitoring.
“A meta-analysis of 28 trials with more than 7000 participants revealed a significant modest positive effect of HBPM (isolated or associated to other co-interventions) on medication adherence when measured objectively by pill count or electronic monitoring [49,50]”
From Home blood pressure monitoring: methodology, clinical relevance and practical application: a 2021 position paper by the Working Group on Blood Pressure Monitoring and Cardiovascular Variability of the European Society of Hypertension (2021) · cites this paper as [50]
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STUDY OF TREATMENT ADHERENCE AMONG PATIENTS WITH HYPERTENSION
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Hypertensive Black Men's Perceptions of a Nurse Administered Medication Protocol
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- Authors
- Parati, G., Omboni, S., Compare, A., Grossi, E., Callus, E., Venco, A., Destro, M., Villa, G., Palatini, P., Rosei, E. A., Scalvini, S., Taddei, S., Manfellotto, D., Favale, S., De Matteis, C., Guglielmi, M., & on behalf of the TELEBPMET Study Group
- Affiliations
- IRCCS Istituto Auxologico Italiano (IT)
- Italian Institute of Telemedicine (IT)
- University of Bergamo (IT)
- Centro Diagnostico Italiano (IT)
- IRCCS Policlinico San Donato (IT)
- University of Insubria (IT)
- Azienda Ospedaliera Treviglio (IT)
- Istituti Clinici Scientifici Maugeri (IT)
- University of Padua (IT)
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
- Fondazione Salvatore Maugeri (IT)
- University of Pisa (IT)
- Fatebenefratelli Hospital (IT)
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT)
- Corresponding author
- Parati, Gianfranco
- ORCID
- Venue
- Trials
- Published
- 2013
- Volume
- 14
- Issue
- 1
- Pages
- 22
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3576326
- OpenAlex
- W2169065879
- Cited by
- 49
- References
- 53
- Citations by year
- 2024: 1 · 2023: 2 · 2022: 3 · 2021: 10 · 2020: 3 · 2019: 2 · 2018: 6 · 2017: 3 · 2016: 3 · 2015: 5 · 2014: 8 · 2013: 3
- FWCI
- 4.31
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- BOA (University of Milano-Bicocca) (submittedVersion, other-oa)
- Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
- Aisberg (University of Bergamo) (submittedVersion, other-oa)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- IrInSubria (University of Insubria) (submittedVersion)
- CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
- Funders
- Università degli Studi di Padova
- Università degli Studi di Brescia
- Università di Pisa
- Fondazione Salvatore Maugeri
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- home blood pressure telemonitoring, hypertension, metabolic syndrome, blood pressure control, medication adherence, ambulatory blood pressure, cardiovascular risk, antihypertensive drugs, treatment persistence
- MeSH terms
- Clinical Protocols, Humans, Hypertension, Outcome Assessment, Health Care, Telemedicine, Blood Pressure Monitoring, Ambulatory, Metabolic Syndrome, Medication Adherence
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