TY - JOUR
T1 - Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension
T2 - a systematic review and meta-analysis of randomised controlled trials
AU - DigiCare4You Consortium
AU - Siopis, George
AU - Moschonis, George
AU - Eweka, Evette
AU - Jung, Jenny
AU - Kwasnicka, Dominika
AU - Asare, Bernard Yeboah Asiamah
AU - Kodithuwakku, Vimarsha
AU - Willems, Ruben
AU - Verhaeghe, Nick
AU - Annemans, Lieven
AU - Vedanthan, Rajesh
AU - Oldenburg, Brian
AU - Manios, Yannis
AU - Gong, Enying
AU - Votis, Konstantinos
AU - Segkouli, Sofia
AU - Triantafyllidis, Andreas
AU - Kyparissis, Odysseas
AU - Paliokas, Ioannis
AU - Polychroniou, Eleftheria
AU - De Craemer, Dirk
AU - Anastasiou, Kostas
AU - Tserpes, Konstantinos
AU - Mavrogianni, Christina
AU - Karaglani, Eva
AU - Kalogerakou, Electra
AU - Maragkoudaki, Maria
AU - Ntzouvani, Agathi
AU - Kontochristopoulou, Katerina
AU - Dupont, Sabine
AU - Dupont, Elizabeth
AU - Dauzon, Leo
AU - Roskams, Maartje
AU - Lennox-Chhugani, Niamh
AU - Perrin, Martin
AU - Day, Niamh Daly
AU - Ferrer, Georgina
AU - Snook, Orla
AU - Aldasoro, Edelweiss
AU - Gil-Salmerón, Alejandro
AU - Peiró, Pilar Gangas
AU - Curran, Darren
AU - Lyne, Fiona
AU - Curreri, Nereide A.
AU - Pierantozzi, Nazzareno
AU - D'Antonio, Claudia
AU - Vespasiani, Giacomo
AU - Almonti, Teresa
AU - Skouteris, Helen
AU - Huang, Keng Yen
N1 - Funding Information:
Coordinator: Yannis Manios. Steering Committee: Yannis Manios, Chiara Seghieri, Djordje Djokic, Konstantinos Votis, Konstantinos Makrilakis, Lieven Annemans, Rajesh Vedanthan, Sabine Dupont. Baker Heart and Diabetes Institute (Australia): Brian Oldenburg, Dominika Kwasnicka, Enying Gong, Jenny Jung, Bernard Yeboah-Asiamah Asare, Vimarsha Kodithuwakku. Centre for Research & Technology Hellas (Greece): Konstantinos Votis, Sofia Segkouli, Anreas Triantafyllidis, Eleftheria Polychroniou, Ioannis Paliokas, Odysseas Kyparissis. Ghent University (Belgium): Lieven Annemans, Nick Verhaeghe, Ruben Willems, Dirk De Craemer. Harokopio University (Greece): Yannis Manios, Kostas Anastasiou, Konstantinos Tserpes, Christina Mavrogianni, Eva Karaglani, Electra Kalogerakou, Maria Maragkoudaki, Agathi Ntzouvani, Katerina Kontochristopoulou. International Diabetes Federation European Region (Belgium): Sabine Dupont, Elizabeth Dupont, Leo Dauzon, Maartje Roskams. International Foundation for Integrated Care (Ireland, Netherlands, UK): Niamh Lennox-Chhugani, Edelweiss Aldasoro, Nereide A. Curreri, Fiona Lyne, Darren Curran, Pilar Gangas Peiró, Alejandro Gil-Salmerón, Orla Snook, Georgina Ferrer, Niamh Daly Day, Martin Perrin. La Trobe University (Australia): George Moschonis, George Siopis. Meteda (Italy): Nazzareno Pierantozzi, Claudia D'Antonio, Giacomo Vespasiani, Teresa Almonti. Monash University (Australia): Helen Skouteris, Tracy Taylor, Melissa Savaglio. National and Kapodistrian University of Athens (Greece): Konstantinos Makrilakis, George Stergiou, Stavros Liatis, George Karamanakos, Chrysi Koliaki, Anastasios Kollias, Eva Zikou, Haris Dimosthenopoulos. New York University Grossman School of Medicine (USA): Rajesh Vedanthan, Keng-Yen Huang, Samrachana Adhikari, Kun Qian, Julia Dickhaus, Kimberly Carney, Evette Eweka. Privanova (France): Farhan Sahito, Dusan Pavlovic, Djordje Djokic, Arzoo Sahito, Gisella Battalova. Sant'Anna School of Advanced Studies (Italy): Chiara Seghieri, Sabina Nutti, Milena Vanieri, Nicola Belle, Gaia Bertarelli, Paola Cantarelli, Francesca Ferre, Anna Noci, Nadia Bozzi, Dina Ferrari, Rachele Borelli, Constanza Tortu. Medical University of Varna (Bulgaria): Violeta Iotova, Yoto Yotov, Natalia Usheva, Kaloyan Tsochev, Tanya Stefanova, Virginia Atanasova, Sonya Koleva, Vanya Marinova, Vanya Russeva, Anna Kozhuharova. Universidad De Zaragoza (Spain): Luis Moreno Aznar, Rosa Magallón Botaya, Gloria Bueno Lozano, Pilar De Miguel-Etayo, Esther Ma Gonzalez-Gil, María L. Miguel-Berges, Natalia Giménez-Legarre, Bárbara Oliván Blázquez, Susana Pérez. University of Medicine, Tirana (Albania): Florian Toti, Skerdi Prifti, Blerina Bombaj, Luftime Bruka, Adriana Lapardhaja, Ornela Laze, Ditila Doracaj. George Siopis is a recipient of Deakin University's Executive Dean Health Research Fellowship.
Funding Information:
The DigiCare4You study has received funding from the EU's Horizon 2020 Research and Innovation Programme (grant agreement 945246). GS, GM, and DK received funding from the National Health and Medical Research Council (NHMRC) of Australia, as part of the NHMRC European Union Collaborative Research Grant Scheme, under the agreement with the NHMRC ID APP2007006. GS is a recipient of an Executive Dean Health Research Fellowship from Deakin University. RV declares receipt by New York University Grossman School of Medicine of a DigiCare4You funding subaward. The content of this Article reflects only the authors' views, and the EU is not liable for any use that may be made of the information contained therein. The authors of this Article wish to thank the authors of included original studies in this review and their statisticians who responded to communication and provided requested information or data. We also thank Meteda's representatives for participating in the initial meeting of the evidence synthesis committee (authors) for the planning of the systematic review. Meteda is a digital health company that develops medical and nutrition software for the management of diabetes. Privanova is a boutique privacy compliance and risk management consultancy. Meteda and Privanova are part of the DigiCare4You Consortium. Meteda and Privanova were not involved in the protocol development; searches; data collection, extraction, analysis, or interpretation; manuscript preparation; or decision to submit the manuscript for publication. None of the authors in this manuscript are associated with Meteda or Privanova. Finally, we thank the members of the DigiCare4You Consortium. Editorial note: The Lancet Group takes a neutral position with respect to territorial claims in published text and tables.
Funding Information:
The DigiCare4You study has received funding from the EU's Horizon 2020 Research and Innovation Programme (grant agreement 945246). GS, GM, and DK received funding from the National Health and Medical Research Council (NHMRC) of Australia, as part of the NHMRC European Union Collaborative Research Grant Scheme, under the agreement with the NHMRC ID APP2007006. GS is a recipient of an Executive Dean Health Research Fellowship from Deakin University. RV declares receipt by New York University Grossman School of Medicine of a DigiCare4You funding subaward. The content of this Article reflects only the authors' views, and the EU is not liable for any use that may be made of the information contained therein. The authors of this Article wish to thank the authors of included original studies in this review and their statisticians who responded to communication and provided requested information or data. We also thank Meteda's representatives for participating in the initial meeting of the evidence synthesis committee (authors) for the planning of the systematic review. Meteda is a digital health company that develops medical and nutrition software for the management of diabetes. Privanova is a boutique privacy compliance and risk management consultancy. Meteda and Privanova are part of the DigiCare4You Consortium. Meteda and Privanova were not involved in the protocol development; searches; data collection, extraction, analysis, or interpretation; manuscript preparation; or decision to submit the manuscript for publication. None of the authors in this manuscript are associated with Meteda or Privanova. Finally, we thank the members of the DigiCare4You Consortium.
Publisher Copyright:
© 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2023/3
Y1 - 2023/3
N2 - Background: Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. Methods: In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. Findings: Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a –3·62 mm Hg (95% CI –5·22 to –2·02) greater reduction in systolic blood pressure, and a –2·45 mm Hg (–3·83 to –1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (–2·45 mm Hg [–4·15 to –0·74]); however, there were no statistically significant reductions for SMS interventions (–1·80 mm Hg [–4·60 to 1·00]) or website interventions (–3·43 mm Hg [–7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. Interpretation: SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility. Funding: European Union's Horizon 2020 Research and Innovation Programme.
AB - Background: Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. Methods: In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. Findings: Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a –3·62 mm Hg (95% CI –5·22 to –2·02) greater reduction in systolic blood pressure, and a –2·45 mm Hg (–3·83 to –1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (–2·45 mm Hg [–4·15 to –0·74]); however, there were no statistically significant reductions for SMS interventions (–1·80 mm Hg [–4·60 to 1·00]) or website interventions (–3·43 mm Hg [–7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. Interpretation: SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility. Funding: European Union's Horizon 2020 Research and Innovation Programme.
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U2 - 10.1016/S2589-7500(23)00002-X
DO - 10.1016/S2589-7500(23)00002-X
M3 - Article
C2 - 36828607
AN - SCOPUS:85148963645
SN - 2589-7500
VL - 5
SP - e144-e159
JO - The Lancet Digital Health
JF - The Lancet Digital Health
IS - 3
ER -