Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol
Abstract Background Lack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence...
| Main Authors: | , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-09-01
|
| Series: | BMC Family Practice |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12875-018-0846-y |
| _version_ | 1811229263222800384 |
|---|---|
| author | José Sanfélix-Genovés Clara L. Rodríguez-Bernal Irene Marco-Moreno Patricia Martinez-Ibañez Lucía Martinez-Ibañez María Bóveda-García Ignacio Barreira-Franch Mercedes Calleja-Del Ser Greta Borrás-Moreno Eugenia Avelino-Hidalgo Marina Escrig-Veses Margherita Lauriano Margarita Giménez-Loreiro Laura Bellot-Pujalte Aníbal García-Sempere Salvador Peiró Gabriel Sanfélix-Gimeno ADAMPA group |
| author_facet | José Sanfélix-Genovés Clara L. Rodríguez-Bernal Irene Marco-Moreno Patricia Martinez-Ibañez Lucía Martinez-Ibañez María Bóveda-García Ignacio Barreira-Franch Mercedes Calleja-Del Ser Greta Borrás-Moreno Eugenia Avelino-Hidalgo Marina Escrig-Veses Margherita Lauriano Margarita Giménez-Loreiro Laura Bellot-Pujalte Aníbal García-Sempere Salvador Peiró Gabriel Sanfélix-Gimeno ADAMPA group |
| author_sort | José Sanfélix-Genovés |
| collection | DOAJ |
| description | Abstract Background Lack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence is limited and not conclusive. We aimed to assess the effectiveness, in the primary care setting, of an intervention that includes educational components, SMBP and self-titration of antihypertensive medication to decrease systolic blood pressure compared to usual care, in a population with poorly controlled hypertension, during a 12-month period. Methods Pragmatic, controlled, randomized, unblinded clinical trial with two parallel groups assigned in a ratio of 1:1 to self-management (which includes educational components, SBMP and self-titration of antihypertensive medication based on a patient’s GP’s pre-established adjustment plan) or to usual care (with educational components too). Discussion If the data from this trial show positive results, the study may contribute to a change of strategy in the treatment of hypertension, focusing on the patient as the main actor to achieve blood pressure control. Furthermore, this approach might contribute to the financial sustainability of the National Health Service. Trial registration This trial has been registered in the database with reference number EudraCT: 2016-003986-25. Registered 05 May 2017, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-003986-25 |
| first_indexed | 2024-04-12T10:11:42Z |
| format | Article |
| id | doaj.art-e2d29cc732154f59aa288d969d272193 |
| institution | Directory Open Access Journal |
| issn | 1471-2296 |
| language | English |
| last_indexed | 2024-04-12T10:11:42Z |
| publishDate | 2018-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Family Practice |
| spelling | doaj.art-e2d29cc732154f59aa288d969d2721932022-12-22T03:37:18ZengBMCBMC Family Practice1471-22962018-09-0119111010.1186/s12875-018-0846-yRationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocolJosé Sanfélix-Genovés0Clara L. Rodríguez-Bernal1Irene Marco-Moreno2Patricia Martinez-Ibañez3Lucía Martinez-Ibañez4María Bóveda-García5Ignacio Barreira-Franch6Mercedes Calleja-Del Ser7Greta Borrás-Moreno8Eugenia Avelino-Hidalgo9Marina Escrig-Veses10Margherita Lauriano11Margarita Giménez-Loreiro12Laura Bellot-Pujalte13Aníbal García-Sempere14Salvador Peiró15Gabriel Sanfélix-Gimeno16ADAMPA groupCentro de Salud de Nazaret, Departamento de Salud de Valencia Clínic-La MalvarrosaHealth Services Research Unit, FISABIOHealth Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Research Institute (INCLIVA)Health Services Research Unit, FISABIOHealth Services Research Unit, FISABIOHealth Services Research Unit, FISABIOAbstract Background Lack of control of hypertension is one of the most prevalent problems encountered by general practitioners (GPs). Self-measured blood pressure monitoring at home (SMBP) and self-titration of medication could be a good strategy to improve hypertension management, however, evidence is limited and not conclusive. We aimed to assess the effectiveness, in the primary care setting, of an intervention that includes educational components, SMBP and self-titration of antihypertensive medication to decrease systolic blood pressure compared to usual care, in a population with poorly controlled hypertension, during a 12-month period. Methods Pragmatic, controlled, randomized, unblinded clinical trial with two parallel groups assigned in a ratio of 1:1 to self-management (which includes educational components, SBMP and self-titration of antihypertensive medication based on a patient’s GP’s pre-established adjustment plan) or to usual care (with educational components too). Discussion If the data from this trial show positive results, the study may contribute to a change of strategy in the treatment of hypertension, focusing on the patient as the main actor to achieve blood pressure control. Furthermore, this approach might contribute to the financial sustainability of the National Health Service. Trial registration This trial has been registered in the database with reference number EudraCT: 2016-003986-25. Registered 05 May 2017, https://www.clinicaltrialsregister.eu/ctr-search/search?query=2016-003986-25http://link.springer.com/article/10.1186/s12875-018-0846-ySelf-monitoringBlood pressureHypertensionSelf-titrationPrimary carePragmatic clinical trial |
| spellingShingle | José Sanfélix-Genovés Clara L. Rodríguez-Bernal Irene Marco-Moreno Patricia Martinez-Ibañez Lucía Martinez-Ibañez María Bóveda-García Ignacio Barreira-Franch Mercedes Calleja-Del Ser Greta Borrás-Moreno Eugenia Avelino-Hidalgo Marina Escrig-Veses Margherita Lauriano Margarita Giménez-Loreiro Laura Bellot-Pujalte Aníbal García-Sempere Salvador Peiró Gabriel Sanfélix-Gimeno ADAMPA group Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol BMC Family Practice Self-monitoring Blood pressure Hypertension Self-titration Primary care Pragmatic clinical trial |
| title | Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol |
| title_full | Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol |
| title_fullStr | Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol |
| title_full_unstemmed | Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol |
| title_short | Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol |
| title_sort | rationale and design of a pragmatic clinical trial to assess the impact of self monitoring blood pressure at home and self titration of antihypertensive medication in poorly controlled hypertension the adampa study protocol |
| topic | Self-monitoring Blood pressure Hypertension Self-titration Primary care Pragmatic clinical trial |
| url | http://link.springer.com/article/10.1186/s12875-018-0846-y |
| work_keys_str_mv | AT josesanfelixgenoves rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT claralrodriguezbernal rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT irenemarcomoreno rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT patriciamartinezibanez rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT luciamartinezibanez rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT mariabovedagarcia rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT ignaciobarreirafranch rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT mercedescallejadelser rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT gretaborrasmoreno rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT eugeniaavelinohidalgo rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT marinaescrigveses rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT margheritalauriano rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT margaritagimenezloreiro rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT laurabellotpujalte rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT anibalgarciasempere rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT salvadorpeiro rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT gabrielsanfelixgimeno rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol AT adampagroup rationaleanddesignofapragmaticclinicaltrialtoassesstheimpactofselfmonitoringbloodpressureathomeandselftitrationofantihypertensivemedicationinpoorlycontrolledhypertensiontheadampastudyprotocol |