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Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs

Lucy Yardley Orcid Logo, Kate Morton Orcid Logo, Kate Greenwell Orcid Logo, Beth Stuart Orcid Logo, Cathy Rice Orcid Logo, Katherine Bradbury Orcid Logo, Ben Ainsworth Orcid Logo, Becky Band Orcid Logo, Elizabeth Murray Orcid Logo, Frances Mair Orcid Logo, Carl May Orcid Logo, Susan Michie Orcid Logo, Samantha Richards-Hall Orcid Logo, Peter Smith Orcid Logo, Anne Bruton Orcid Logo, James Raftery Orcid Logo, Shihua Zhu Orcid Logo, Mike Thomas Orcid Logo, Richard J McManus Orcid Logo, Paul Little Orcid Logo

Programme Grants for Applied Research, Volume: 10, Issue: 11, Pages: 1 - 108

Swansea University Author: Becky Band Orcid Logo

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DOI (Published version): 10.3310/bwfi7321

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BackgroundDigital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digi...

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Published in: Programme Grants for Applied Research
ISSN: 2050-4322 2050-4330
Published: National Institute for Health and Care Research 2022
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This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS.ObjectivesThe overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care.DesignFor the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation.SettingGeneral practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England.ParticipantsFor the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life.InterventionsOur hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of pharmacological self-management strategies (e.g. medication adherence and appropriate health-care service use) and non-pharmacological self-management strategies (e.g. breathing retraining, stress reduction and healthy behaviour change). The control group were given an Asthma UK (London, UK) information booklet on asthma self-management and received routine asthma care.Main outcome measuresThe primary outcome for the hypertension randomised controlled trial was difference between intervention and usual-care groups in mean systolic blood pressure (mmHg) at 12 months, adjusted for baseline blood pressure, blood pressure target (i.e. standard, diabetic or aged &gt; 80 years), age and general practice. The primary outcome for the asthma feasibility study was the feasibility of the trial design, including recruitment, adherence, intervention engagement and retention at follow-up. Health-care utilisation data were collected via notes review.Review methodsThe quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography.ResultsA total of 622 hypertensive patients were recruited to the randomised controlled trial, and 552 (89%) were followed up at 12 months. Systolic blood pressure was significantly lower in the intervention group at 12 months, with a difference of –3.4 mmHg (95% confidence interval –6.1 to –0.8 mmHg), and this gave an incremental cost per unit of systolic blood pressure reduction of £11 (95% confidence interval £5 to £29). Owing to a cost difference of £402 and a quality-adjusted life-year (QALY) difference of 0.044, long-term modelling puts the incremental cost per QALY at just over £9000. The probability of being cost-effective was 66% at willingness to pay £20,000 per quality-adjusted life-year, and this was higher at higher thresholds. A total of 88 patients were recruited to the asthma feasibility trial (target n = 80; n = 44 in each arm). At 3-month follow-up, two patients withdrew and six patients did not complete outcome measures. At 12 months, two patients withdrew and four patients did not complete outcome measures. A total of 36 out of 44 patients in the intervention group engaged with My Breathing Matters [with a median of four (range 0–25) logins].LimitationsAlthough the interventions were designed to be as accessible as was feasible, most trial participants were white and participants of lower socioeconomic status were less likely to take part and complete follow-up measures. Challenges remain in terms of integrating digital interventions with clinical records.ConclusionsA digital intervention using self-monitored blood pressure to inform medication titration led to significantly lower blood pressure in participants than usual care. The observed reduction in blood pressure would be expected to lead to a reduction of 10–15% in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered randomised controlled trial of the intervention is warranted. The theory-, evidence- and person-based approaches to intervention development refined through this programme enabled us to identify and address important contextual barriers to and facilitators of engagement with the interventions.Future workThis research justifies consideration of further implementation of the hypertension intervention, a fully powered randomised controlled trial of the asthma intervention and wide dissemination of our methods for intervention development. Our interventions can also be adapted for a range of other health conditions.</abstract><type>Journal Article</type><journal>Programme Grants for Applied Research</journal><volume>10</volume><journalNumber>11</journalNumber><paginationStart>1</paginationStart><paginationEnd>108</paginationEnd><publisher>National Institute for Health and Care Research</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2050-4322</issnPrint><issnElectronic>2050-4330</issnElectronic><keywords/><publishedDay>1</publishedDay><publishedMonth>12</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-12-01</publishedDate><doi>10.3310/bwfi7321</doi><url/><notes/><college>COLLEGE NANME</college><department>Health and Social Care School</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HSOC</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>Funded by PGfAR</funders><projectreference/><lastEdited>2024-09-02T17:40:41.2854708</lastEdited><Created>2024-07-09T15:18:45.7941819</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Psychology</level></path><authors><author><firstname>Lucy</firstname><surname>Yardley</surname><orcid>0000-0002-3853-883x</orcid><order>1</order></author><author><firstname>Kate</firstname><surname>Morton</surname><orcid>0000-0002-6674-0314</orcid><order>2</order></author><author><firstname>Kate</firstname><surname>Greenwell</surname><orcid>0000-0002-3662-1488</orcid><order>3</order></author><author><firstname>Beth</firstname><surname>Stuart</surname><orcid>0000-0001-5432-7437</orcid><order>4</order></author><author><firstname>Cathy</firstname><surname>Rice</surname><orcid>0000-0001-5961-2413</orcid><order>5</order></author><author><firstname>Katherine</firstname><surname>Bradbury</surname><orcid>0000-0001-5513-7571</orcid><order>6</order></author><author><firstname>Ben</firstname><surname>Ainsworth</surname><orcid>0000-0002-5098-1092</orcid><order>7</order></author><author><firstname>Becky</firstname><surname>Band</surname><orcid>0000-0001-5403-1708</orcid><order>8</order></author><author><firstname>Elizabeth</firstname><surname>Murray</surname><orcid>0000-0002-8932-3695</orcid><order>9</order></author><author><firstname>Frances</firstname><surname>Mair</surname><orcid>0000-0001-9780-1135</orcid><order>10</order></author><author><firstname>Carl</firstname><surname>May</surname><orcid>0000-0002-0451-2690</orcid><order>11</order></author><author><firstname>Susan</firstname><surname>Michie</surname><orcid>0000-0003-0063-6378</orcid><order>12</order></author><author><firstname>Samantha</firstname><surname>Richards-Hall</surname><orcid>0000-0002-7665-4268</orcid><order>13</order></author><author><firstname>Peter</firstname><surname>Smith</surname><orcid>0000-0003-4423-5410</orcid><order>14</order></author><author><firstname>Anne</firstname><surname>Bruton</surname><orcid>0000-0002-4550-2536</orcid><order>15</order></author><author><firstname>James</firstname><surname>Raftery</surname><orcid>0000-0003-1094-8578</orcid><order>16</order></author><author><firstname>Shihua</firstname><surname>Zhu</surname><orcid>0000-0002-1430-713x</orcid><order>17</order></author><author><firstname>Mike</firstname><surname>Thomas</surname><orcid>0000-0001-5939-1155</orcid><order>18</order></author><author><firstname>Richard J</firstname><surname>McManus</surname><orcid>0000-0003-3638-028x</orcid><order>19</order></author><author><firstname>Paul</firstname><surname>Little</surname><orcid>0000-0003-3664-1873</orcid><order>20</order></author></authors><documents><document><filename>67019__31243__c449da9ab1714dcd85d9db492589cb7e.pdf</filename><originalFilename>67019.VoR.pdf</originalFilename><uploaded>2024-09-02T17:38:37.5924522</uploaded><type>Output</type><contentLength>2208034</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>Copyright © 2022 Yardley et al. 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spelling v2 67019 2024-07-09 Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs 06b53a31f254b004de8649a376ce2fbd 0000-0001-5403-1708 Becky Band Becky Band true false 2024-07-09 HSOC BackgroundDigital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS.ObjectivesThe overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care.DesignFor the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation.SettingGeneral practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England.ParticipantsFor the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life.InterventionsOur hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of pharmacological self-management strategies (e.g. medication adherence and appropriate health-care service use) and non-pharmacological self-management strategies (e.g. breathing retraining, stress reduction and healthy behaviour change). The control group were given an Asthma UK (London, UK) information booklet on asthma self-management and received routine asthma care.Main outcome measuresThe primary outcome for the hypertension randomised controlled trial was difference between intervention and usual-care groups in mean systolic blood pressure (mmHg) at 12 months, adjusted for baseline blood pressure, blood pressure target (i.e. standard, diabetic or aged > 80 years), age and general practice. The primary outcome for the asthma feasibility study was the feasibility of the trial design, including recruitment, adherence, intervention engagement and retention at follow-up. Health-care utilisation data were collected via notes review.Review methodsThe quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography.ResultsA total of 622 hypertensive patients were recruited to the randomised controlled trial, and 552 (89%) were followed up at 12 months. Systolic blood pressure was significantly lower in the intervention group at 12 months, with a difference of –3.4 mmHg (95% confidence interval –6.1 to –0.8 mmHg), and this gave an incremental cost per unit of systolic blood pressure reduction of £11 (95% confidence interval £5 to £29). Owing to a cost difference of £402 and a quality-adjusted life-year (QALY) difference of 0.044, long-term modelling puts the incremental cost per QALY at just over £9000. The probability of being cost-effective was 66% at willingness to pay £20,000 per quality-adjusted life-year, and this was higher at higher thresholds. A total of 88 patients were recruited to the asthma feasibility trial (target n = 80; n = 44 in each arm). At 3-month follow-up, two patients withdrew and six patients did not complete outcome measures. At 12 months, two patients withdrew and four patients did not complete outcome measures. A total of 36 out of 44 patients in the intervention group engaged with My Breathing Matters [with a median of four (range 0–25) logins].LimitationsAlthough the interventions were designed to be as accessible as was feasible, most trial participants were white and participants of lower socioeconomic status were less likely to take part and complete follow-up measures. Challenges remain in terms of integrating digital interventions with clinical records.ConclusionsA digital intervention using self-monitored blood pressure to inform medication titration led to significantly lower blood pressure in participants than usual care. The observed reduction in blood pressure would be expected to lead to a reduction of 10–15% in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered randomised controlled trial of the intervention is warranted. The theory-, evidence- and person-based approaches to intervention development refined through this programme enabled us to identify and address important contextual barriers to and facilitators of engagement with the interventions.Future workThis research justifies consideration of further implementation of the hypertension intervention, a fully powered randomised controlled trial of the asthma intervention and wide dissemination of our methods for intervention development. Our interventions can also be adapted for a range of other health conditions. Journal Article Programme Grants for Applied Research 10 11 1 108 National Institute for Health and Care Research 2050-4322 2050-4330 1 12 2022 2022-12-01 10.3310/bwfi7321 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Funded by PGfAR 2024-09-02T17:40:41.2854708 2024-07-09T15:18:45.7941819 Faculty of Medicine, Health and Life Sciences School of Psychology Lucy Yardley 0000-0002-3853-883x 1 Kate Morton 0000-0002-6674-0314 2 Kate Greenwell 0000-0002-3662-1488 3 Beth Stuart 0000-0001-5432-7437 4 Cathy Rice 0000-0001-5961-2413 5 Katherine Bradbury 0000-0001-5513-7571 6 Ben Ainsworth 0000-0002-5098-1092 7 Becky Band 0000-0001-5403-1708 8 Elizabeth Murray 0000-0002-8932-3695 9 Frances Mair 0000-0001-9780-1135 10 Carl May 0000-0002-0451-2690 11 Susan Michie 0000-0003-0063-6378 12 Samantha Richards-Hall 0000-0002-7665-4268 13 Peter Smith 0000-0003-4423-5410 14 Anne Bruton 0000-0002-4550-2536 15 James Raftery 0000-0003-1094-8578 16 Shihua Zhu 0000-0002-1430-713x 17 Mike Thomas 0000-0001-5939-1155 18 Richard J McManus 0000-0003-3638-028x 19 Paul Little 0000-0003-3664-1873 20 67019__31243__c449da9ab1714dcd85d9db492589cb7e.pdf 67019.VoR.pdf 2024-09-02T17:38:37.5924522 Output 2208034 application/pdf Version of Record true Copyright © 2022 Yardley et al. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence. true eng https://creativecommons.org/licenses/by/4.0/deed.en
title Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
spellingShingle Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
Becky Band
title_short Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
title_full Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
title_fullStr Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
title_full_unstemmed Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
title_sort Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs
author_id_str_mv 06b53a31f254b004de8649a376ce2fbd
author_id_fullname_str_mv 06b53a31f254b004de8649a376ce2fbd_***_Becky Band
author Becky Band
author2 Lucy Yardley
Kate Morton
Kate Greenwell
Beth Stuart
Cathy Rice
Katherine Bradbury
Ben Ainsworth
Becky Band
Elizabeth Murray
Frances Mair
Carl May
Susan Michie
Samantha Richards-Hall
Peter Smith
Anne Bruton
James Raftery
Shihua Zhu
Mike Thomas
Richard J McManus
Paul Little
format Journal article
container_title Programme Grants for Applied Research
container_volume 10
container_issue 11
container_start_page 1
publishDate 2022
institution Swansea University
issn 2050-4322
2050-4330
doi_str_mv 10.3310/bwfi7321
publisher National Institute for Health and Care Research
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Psychology{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Psychology
document_store_str 1
active_str 0
description BackgroundDigital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS.ObjectivesThe overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care.DesignFor the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation.SettingGeneral practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England.ParticipantsFor the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life.InterventionsOur hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of pharmacological self-management strategies (e.g. medication adherence and appropriate health-care service use) and non-pharmacological self-management strategies (e.g. breathing retraining, stress reduction and healthy behaviour change). The control group were given an Asthma UK (London, UK) information booklet on asthma self-management and received routine asthma care.Main outcome measuresThe primary outcome for the hypertension randomised controlled trial was difference between intervention and usual-care groups in mean systolic blood pressure (mmHg) at 12 months, adjusted for baseline blood pressure, blood pressure target (i.e. standard, diabetic or aged > 80 years), age and general practice. The primary outcome for the asthma feasibility study was the feasibility of the trial design, including recruitment, adherence, intervention engagement and retention at follow-up. Health-care utilisation data were collected via notes review.Review methodsThe quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography.ResultsA total of 622 hypertensive patients were recruited to the randomised controlled trial, and 552 (89%) were followed up at 12 months. Systolic blood pressure was significantly lower in the intervention group at 12 months, with a difference of –3.4 mmHg (95% confidence interval –6.1 to –0.8 mmHg), and this gave an incremental cost per unit of systolic blood pressure reduction of £11 (95% confidence interval £5 to £29). Owing to a cost difference of £402 and a quality-adjusted life-year (QALY) difference of 0.044, long-term modelling puts the incremental cost per QALY at just over £9000. The probability of being cost-effective was 66% at willingness to pay £20,000 per quality-adjusted life-year, and this was higher at higher thresholds. A total of 88 patients were recruited to the asthma feasibility trial (target n = 80; n = 44 in each arm). At 3-month follow-up, two patients withdrew and six patients did not complete outcome measures. At 12 months, two patients withdrew and four patients did not complete outcome measures. A total of 36 out of 44 patients in the intervention group engaged with My Breathing Matters [with a median of four (range 0–25) logins].LimitationsAlthough the interventions were designed to be as accessible as was feasible, most trial participants were white and participants of lower socioeconomic status were less likely to take part and complete follow-up measures. Challenges remain in terms of integrating digital interventions with clinical records.ConclusionsA digital intervention using self-monitored blood pressure to inform medication titration led to significantly lower blood pressure in participants than usual care. The observed reduction in blood pressure would be expected to lead to a reduction of 10–15% in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered randomised controlled trial of the intervention is warranted. The theory-, evidence- and person-based approaches to intervention development refined through this programme enabled us to identify and address important contextual barriers to and facilitators of engagement with the interventions.Future workThis research justifies consideration of further implementation of the hypertension intervention, a fully powered randomised controlled trial of the asthma intervention and wide dissemination of our methods for intervention development. Our interventions can also be adapted for a range of other health conditions.
published_date 2022-12-01T17:40:39Z
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