Abstract
Background: Digital interventions (DIs) offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability, and cost-effectiveness of DIs remains mixed. This programme focused on the potential for self-management DIs to improve outcomes in two common, contrasting conditions (hypertension and asthma) where care is currently sub-optimal, leading to excess deaths, illness, disability, and costs for the NHS.
Objective(s): The overall purpose was to address the question of how DIs can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial DIs 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 DIs could make them acceptable, feasible, effective, and cost-effective to integrate into primary care.
Design: Hypertension strand: Systematic reviews of quantitative and qualitative evidence, intervention planning, development, and optimisation, unmasked randomised controlled trial (RCT) comparing DI with usual care, with a health economic analysis, and nested process evaluation.
Asthma strand: Systematic review of quantitative evidence, intervention planning, development, and optimisation, and feasibility RCT comparing DI with usual care, with nested process evaluation.
Setting: General practices (76 hypertension; 7 asthma) across Wessex and Thames Valley regions in Southern England.
Participants: People with uncontrolled hypertension taking 1-3 antihypertensive medications; adults with asthma and impaired asthma-related quality of life.
Interventions:
HOME BP: A DI including motivational training for patients to self-monitor blood pressure (BP) and healthcare professionals to support self-management; a digital interface to send monthly readings to the healthcare professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for two consecutive months; and support for optional patient healthy behaviour change (healthy diet/weight loss, increased physical activity, reduced alcohol and salt consumption). The control group were provided with the Blood Pressure UK leaflet for hypertension and received routine hypertension care.
My Breathing Matters: A DI 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 (medication adherence, appropriate health care service use) and non-pharmacological (breathing retraining, stress reduction, healthy behaviour change) self-management strategies. The control group were given the Asthma UK information booklet on asthma self-management and received routine asthma care.
Main outcome measures: The primary outcome for the hypertension RCT was difference between intervention and usual care groups in mean systolic BP (mmHg) at 12-months, adjusted for baseline BP, BP target (standard, diabetic or aged over 80), age, and General Practitioner (GP) 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. Healthcare utilisation data were collected via notes review. Review methods: The quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography.
Results: 622 hypertensive patients were recruited to the RCT, and 552 (89 per cent) were followed-up at 12-months. Systolic BP was significantly lower in the intervention group at 12-months with a difference of -3.53 mmHg (-6.19, -0.86). This gave an incremental cost per unit of systolic BP reduction of £11 (95% CI £5 to £29). Long-term modelling puts the incremental cost per QALY at just over £9k. due to a cost difference of £402, and a QALY difference of 0.044. The probability of being cost effective was 66% at willingness to pay of £20k per QALY and higher at higher thresholds. 88 patients were recruited to the asthma feasibility trial (target 80; 44 in each arm). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with My Breathing Matters (median of four logins, range 0-25).
Limitations: Although the interventions were designed to be as accessible as was feasible, most trial participants were white and those 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.
Conclusions: A DI using self-monitored BP to inform medication titration led to significantly lower BP than usual care. The observed reduction in BP would be expected to lead to a reduction of 10-15 per cent in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered RCT study of the intervention is warranted. The theory-, evidence- and person-based approach 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 work: This research justifies consideration of further implementation of the hypertension intervention, a fully powered RCT 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.
Study registration: ISRCTN13790648 (hypertension); ISRCTN15698435 (asthma); PROSPERO CRD42013004773 (hypertension review) CRD42014013455 (asthma review).
Funding details: This project was funded by the NIHR Programme Grants for Applied Research and will be published in full in Programme Grants for Applied Research; Vol. X, No. X. See the NIHR Journals Library PGfAR project pages for further information.
Objective(s): The overall purpose was to address the question of how DIs can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial DIs 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 DIs could make them acceptable, feasible, effective, and cost-effective to integrate into primary care.
Design: Hypertension strand: Systematic reviews of quantitative and qualitative evidence, intervention planning, development, and optimisation, unmasked randomised controlled trial (RCT) comparing DI with usual care, with a health economic analysis, and nested process evaluation.
Asthma strand: Systematic review of quantitative evidence, intervention planning, development, and optimisation, and feasibility RCT comparing DI with usual care, with nested process evaluation.
Setting: General practices (76 hypertension; 7 asthma) across Wessex and Thames Valley regions in Southern England.
Participants: People with uncontrolled hypertension taking 1-3 antihypertensive medications; adults with asthma and impaired asthma-related quality of life.
Interventions:
HOME BP: A DI including motivational training for patients to self-monitor blood pressure (BP) and healthcare professionals to support self-management; a digital interface to send monthly readings to the healthcare professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for two consecutive months; and support for optional patient healthy behaviour change (healthy diet/weight loss, increased physical activity, reduced alcohol and salt consumption). The control group were provided with the Blood Pressure UK leaflet for hypertension and received routine hypertension care.
My Breathing Matters: A DI 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 (medication adherence, appropriate health care service use) and non-pharmacological (breathing retraining, stress reduction, healthy behaviour change) self-management strategies. The control group were given the Asthma UK information booklet on asthma self-management and received routine asthma care.
Main outcome measures: The primary outcome for the hypertension RCT was difference between intervention and usual care groups in mean systolic BP (mmHg) at 12-months, adjusted for baseline BP, BP target (standard, diabetic or aged over 80), age, and General Practitioner (GP) 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. Healthcare utilisation data were collected via notes review. Review methods: The quantitative reviews included a meta-analysis. The qualitative review comprised a meta-ethnography.
Results: 622 hypertensive patients were recruited to the RCT, and 552 (89 per cent) were followed-up at 12-months. Systolic BP was significantly lower in the intervention group at 12-months with a difference of -3.53 mmHg (-6.19, -0.86). This gave an incremental cost per unit of systolic BP reduction of £11 (95% CI £5 to £29). Long-term modelling puts the incremental cost per QALY at just over £9k. due to a cost difference of £402, and a QALY difference of 0.044. The probability of being cost effective was 66% at willingness to pay of £20k per QALY and higher at higher thresholds. 88 patients were recruited to the asthma feasibility trial (target 80; 44 in each arm). At 3-month follow-up, two patients withdrew and six did not complete outcome measures. At 12 months, two withdrew and four did not complete outcome measures. 36/44 patients in the intervention group engaged with My Breathing Matters (median of four logins, range 0-25).
Limitations: Although the interventions were designed to be as accessible as was feasible, most trial participants were white and those 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.
Conclusions: A DI using self-monitored BP to inform medication titration led to significantly lower BP than usual care. The observed reduction in BP would be expected to lead to a reduction of 10-15 per cent in patients suffering a stroke. The feasibility trial of My Breathing Matters suggests that a fully powered RCT study of the intervention is warranted. The theory-, evidence- and person-based approach 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 work: This research justifies consideration of further implementation of the hypertension intervention, a fully powered RCT 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.
Study registration: ISRCTN13790648 (hypertension); ISRCTN15698435 (asthma); PROSPERO CRD42013004773 (hypertension review) CRD42014013455 (asthma review).
Funding details: This project was funded by the NIHR Programme Grants for Applied Research and will be published in full in Programme Grants for Applied Research; Vol. X, No. X. See the NIHR Journals Library PGfAR project pages for further information.
| Original language | English |
|---|---|
| Number of pages | 144 |
| Volume | 10 |
| No. | 11 |
| Specialist publication | NIHR Open Research |
| DOIs | |
| Publication status | Published - 19 Dec 2022 |
Bibliographical note
Funding Information:During the period of this programme grant, we started to actively disseminate the PBA to the wider research and intervention development community by a variety of methods. As planned in the DIPSS proposal, we held three workshops funded by the DIPSS grant and used these workshops to illustrate the methods and the value of the PBA for developing the DIPSS interventions. We also presented the use of the PBA at conferences through symposia, workshops and individual papers, and we now have a dedicated website [URL: www.personbasedapproach.org (accessed 8 August 2022)] and newsletter to update the research community on the latest developments in the approach (see Report Supplementary Material 2 for a full list of dissemination events). We have found the research community very receptive to, and appreciative of, the PBA methods, and our discussions of our methods at these workshops and presentations have stimulated and helped us to develop our methods further. As the PBA has become more widely known, the PBA has, in turn, directly informed development of more generic national guidance, such as the Medical Research Council-funded INDEX guidance (see Chapters 2 and 4) and the Public Health England guidance.25,85
Funding Information:
Declared competing interests of authors: Lucy Yardley reports membership of the Health Technology Assessment (HTA) Antimicrobial Resistance Board (2013–14), HTA Efficient Study Designs Board (2015–16) and Public Health Research Funding Board (2015–17). Beth Stuart reports membership of the HTA Commissioning Committee (2020–4). Ben Ainsworth reports membership of the HTA Commissioning Committee (2020–1). Elizabeth Murray received grants from the Wellcome Trust India Alliance (Hyderabad, India), the National Health and Medical Research Council (Canberra, ACT, Australia), Alcohol Research UK (London, UK), Macmillan Cancer Support (London, UK) and the Medical Research Council (London, UK), during the conduct of the study. Frances Mair received personal fees from Janssen-Cilag Limited for activities outside the submitted work. James Raftery is an active member of the National Institute for Health and Care Research (NIHR) HTA Editorial Board and the NIHR Efficacy and Mechanism Evaluation Editorial Board. Mike Thomas reports membership of the HTA PCCPI Panel (2015–18). Richard J McManus received blood pressure monitors for research purposes from OMRON (Milton Keynes, UK), grants from the Stroke Association (London, UK) and travel funding from the European Society of Hypertension, outside the submitted work. In addition, Richard J McManus reports membership of the HTA Clinical Evaluation and Trials Committee (2010–15). Paul Little was the director of NIHR Programme Grants for Applied Research programme and reports membership of the NIHR Journals Library Board (2012–18).
Funding Information:
This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 11. See the NIHR Journals Library website for further information.
Publisher Copyright:
© 2022, NIHR Journals Library. All rights reserved.
Research Groups and Themes
- Physical and Mental Health
Keywords
- digital intervention
- asthma
- respiratory
- hypertension
- blood pressure
- primary health care
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