A qualitative study of stakeholders' experiences with and acceptability of a technology-supported health coaching intervention (SHARE-S) delivered in coordination with cancer survivorship care.

PURPOSE: Healthy cancer survivorship involves patients' active engagement with preventative health behaviors and follow-up care. While clinicians and patients have typically held dual responsibility for activating these behaviors, transitioning some clinician effort to technology and health coaches may enhance guideline implementation. This paper reports on the acceptability of the Shared Healthcare Actions & Reflections Electronic systems in survivorship (SHARE-S) program, an entirely virtual multicomponent intervention incorporating e-referrals, remotely-delivered health coaching, and automated text messages to enhance patient self-management and promote healthy survivorship. METHODS: SHARE-S was evaluated in single group hybrid implementation-effectiveness pilot study. Patients were e-referred from the clinical team to health coaches for three health self-management coaching calls and received text messages to enhance coaching. Semi-structured qualitative interviews were conducted with 21 patient participants, 2 referring clinicians, and 2 health coaches to determine intervention acceptability (attitudes, appropriateness, suitability, convenience, and perceived effectiveness) and to identify important elements of the program and potential mechanisms of action to guide future implementation. RESULTS: SHARE-S was described as impactful and convenient. The nondirective, patient-centered health coaching and mindfulness exercises were deemed most acceptable; text messages were less acceptable. Stakeholders suggested increased flexibility in format, frequency, timing, and length of participation, and additional tailored educational materials. Patients reported tangible health behavior changes, improved mood, and increased accountability and self-efficacy. CONCLUSIONS: SHARE-S is overall an acceptable and potentially effective intervention that may enhance survivors' self-management and well-being. Alterations to tailored content, timing, and dose should be tested to determine impact on acceptability and outcomes.

Self-Management Using eHealth Technologies for Liver Transplant Recipients: Scoping Review.

BACKGROUND: Liver transplantation has become increasingly common as a last-resort treatment for end-stage liver diseases and liver cancer, with continually improving success rates and long-term survival rates. Nevertheless, liver transplant recipients face lifelong challenges in self-management, including immunosuppressant therapy, lifestyle adjustments, and navigating complex health care systems. eHealth technologies hold the potential to aid and optimize self-management outcomes, but their adoption has been slow in this population due to the complexity of post-liver transplant management. OBJECTIVE: This study aims to examine the use of eHealth technologies in supporting self-management for liver transplant recipients and identify their benefits and challenges to suggest areas for further research. METHODS: Following the Arksey and O'Malley methodology for scoping reviews, we conducted a systematic search of 5 electronic databases: PubMed, CINAHL, Embase, PsycINFO, and Web of Science. We included studies that (1) examined or implemented eHealth-based self-management, (2) included liver transplant recipients aged ≥18 years, and (3) were published in a peer-reviewed journal. We excluded studies that (1) were case reports, conference abstracts, editorials, or letters; (2) did not focus on the posttransplantation phase; (3) did not focus on self-management; and (4) did not incorporate the concept of eHealth or used technology solely for data collection. The quality of the selected eHealth interventions was evaluated using (1) the Template for Intervention Description and Replication guidelines and checklist and (2) the 5 core self-management skills identified by Lorig and Holman. RESULTS: Of 1461 articles, 15 (1.03%) studies were included in the final analysis. Our findings indicate that eHealth-based self-management strategies for adult liver transplant recipients primarily address lifestyle management, medication adherence, and remote monitoring, highlighting a notable gap in alcohol relapse interventions. The studies used diverse technologies, including mobile apps, videoconferencing, and telehealth platforms, but showed limited integration of decision-making or resource use skills essential for comprehensive self-management. The reviewed studies highlighted the potential of eHealth in enhancing individualized health care, but only a few included collaborative features such as 2-way communication or tailored goal setting. While adherence and feasibility were generally high in many interventions, their effectiveness varied due to diverse methodologies and outcome measures. CONCLUSIONS: This scoping review maps the current literature on eHealth-based self-management support for liver transplant recipients, assessing its potential and challenges. Future studies should focus on developing predictive models and personalized eHealth interventions rooted in patient-generated data, incorporating digital human-to-human interactions to effectively address the complex needs of liver transplant recipients. This review emphasizes the need for future eHealth self-management research to address the digital divide, especially with the aging liver transplant recipient population, and ensure more inclusive studies across diverse ethnicities and regions.

Effects of tracking linkage self-management mode on the compliance of prenatal examinations and delivery modes in primiparas.

To explore the effects of tracking linkage self-management mode on the compliance of prenatal examinations and delivery modes in primiparas. A total of 270 primiparas undergoing prenatal examinations in Shijiazhuang Obstetrics and Gynecology Hospital were enrolled for prospective study between January 2021 and January 2022. They were divided into control group and observation group, 135 cases in each group. The control group was given routine management mode, while observation group was given tracking linkage self-management mode. All were intervened till discharge. The compliance (time and frequency of prenatal examinations), cognition of prenatal examinations, score of exercise of self-care agency scale, self-rating anxiety scale and self-rating depression scale, delivery modes and the occurrence of neonatal adverse outcomes were compared between the 2 groups. After intervention, total compliance rate of prenatal examinations in observation group was higher than that in control group (84.44% vs 72.59%) (P < .05). The scores of pregnancy care, genetic diseases counseling, prevention of birth defects and reasonable nutrition during pregnancy in observation group were higher than those in control group (P < .05), scores of health cognition, self-care skills, self-care responsibility and self-concept were higher than those in control group (P < .05), scores of self-rating anxiety scale and self-rating depression scale were lower than those in control group (P < .05), natural delivery rate was higher than that in control group (85.93% vs 74.81%) (P < .05), and incidence of neonatal adverse outcomes was lower than that in control group (0.74% vs 5.93%) (Fisher exact probability = 0.036). The application of tracking linkage self-management mode can significantly improve cognition to prenatal examinations, improve compliance of prenatal examinations and self-care ability, relieve anxiety and depression, increase natural delivery rate and reduce the incidence of neonatal adverse outcomes in primiparas.

Low back pain self-management mobile applications: a systematic review on digital platforms.

OBJECTIVE: To identify and analyze the features and quality of self-management support of mobile applications available in Brazil for chronic low back pain in adults. METHOD: A systematic review on the Apple Store® and Google Play® digital platforms. The Self-Management Support Assessment Tool scale was used to assess self-management support and the Institute for Healthcare Informatics Functionality Score scale was used to assess functionality. RESULTS: Seventeen applications were selected, which included around seven self-management skills. The applications that met the majority of self-management support skills were Pathways, Branch, Pancea, Pain Navigator, and Curable. The Curable, Branch and MoovButh applications had the highest scores, with ten features on the functionality scale. CONCLUSION: Some applications have the potential to complement in-person treatment in terms of validity, acceptability and clinical usefulness in pain management. However, barriers such as lack of partnership between healthcare providers and patients, limited evidence-based content, social support, cultural relevance, cost, language, security and privacy can limit their sustained use. PROSPERO Registration: CRD42022382686.

Potential profiling of self-management skills in older co-morbid patients.

BACKGROUND: Under the general trend of global aging, geriatric comorbidity is increasingly common, which may have some impact on the quality of life of the older people. Self-management can effectively improve patient compliance, subjective initiative, and improve patient quality of life. However, the present situation of self-management in different old people is different. Therefore, this study classifies older co-morbid patients through potential profiling analysis, understands the category characteristics of self-management level of older co-morbid patients, and discusses the influencing factors of self-management level of different categories of older co-morbid patients, which can provide reference for personalized intervention programs for different comorbidity characteristics of elderly people in the future.  METHOD: Through a cross-sectional study, 616 cases of older co-morbid patients in three districts of Zhengzhou City, Henan Province, were selected as survey subjects by using the whole cluster sampling method. The General Information Questionnaire, Chronic Disease Self-Management Scale, Health Literacy Scale, Electronic Health Literacy Scale, Collaborative Social Support Scale, and Health Empowerment Scale were used to conduct the survey. RESULTS: The result of LPA shows that the self-management characteristics of older co-morbid patients should be classified into 3 categories: good self-management (19.4%), medium self-management(27.9%), and low self-management (52.7%). The results of multivariate logistic regression analyses show that literacy, religiosity, health literacy, e-health literacy, appreciative social support, and health empowerment are influential factors for self-management among older co-morbid patients (p < 0.05). CONCLUSION: There is obvious heterogeneity in the self-management level of older co-morbid patients. It is recommended that healthcare professionals give targeted interventions for their weaknesses according to the self-management characteristics of different categories of patients in order to enhance the self-management level of this population and improve their quality of life.

Impact of lifestyle and dietary modifications for endometriosis development and symptom management.

PURPOSE OF REVIEW: Management of endometriosis is often complex and poorly studied. Patients with endometriosis have interest in how their lifestyle may affect their diagnosis. Self-management and lifestyle changes are often used as adjunct therapy, but best practices are not concrete in treatment guidelines. RECENT FINDINGS: Lifestyle impact on endometriosis and possible self-management treatment therapies are reviewed. Overall, there is a need for future studies in all topics. Data suggest a link between endocrine-disrupting chemicals (EDCs), particularly persistent EDCs, and endometriosis. More work is needed to isolate and quantify exposures and explore their connection to endometriosis in order to provide guidance for clinical practice recommendations. There is insufficient evidence to support a superior diet for management of endometriosis; however, the Mediterranean diet may have the most benefit without nutrition concerns. Exercise may be another tool to improve endometriosis symptoms, but once again data are limited and best type and frequency is not well studied. Best evidence supports body-mind practices such as yoga, although new evidence suggests benefit from a holistic combination of several types of exercises. SUMMARY: Overall, data on lifestyle effects and associated therapies are limited. Future high-quality studies are needed to guide practice.

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness.

BACKGROUND: Low back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). METHODS: Participants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486. FINDINGS: Between Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference -0·5 [97·5% CI -1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (-0·6 [-1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care. INTERPRETATION: The SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice. FUNDING: National Institute for Health and Care Research Health Technology Assessment (16/111/78).

Factors Associated with Non-Adherence to Self-Management Among Patients with Chronic Obstructive Pulmonary Disease: A Survey Using the Delphi Technique and Analytic Hierarchy Process.

Background: The relevant factors and patterns of non-adherence to self-management among patients with chronic obstructive pulmonary disease (COPD) need to be elucidated to improve self-management. Purpose: This study was a survey to prioritize the relevance of factors associated with non-adherence to COPD self-management using the Delphi technique and analytic hierarchy process (AHP). Patients and Methods: A total of 15 expert panels were established to determine the priority of relevant factors in a three-round Delphi survey and an AHP. To develop the preliminary conceptual framework for non-adherence to COPD self-management, findings from a systematic literature review, a qualitative study using in-depth interviews with COPD patients, and the first round of the Delphi survey were integrated. Based on the preliminary framework, the content validity ratio (CVR) was analyzed to examine the consensus among expert panels in the second and third rounds of the Delphi survey, and the relative weight was determined by pairwise comparisons between alternative factors in the AHP. Results: In developing the preliminary conceptual framework, 8 factor categories and 53 factors were identified as relevant to non-adherence to COPD self-management. Of the 53 factors, 22 factors with a CVR of 0.49 or higher were identified in the Delphi survey. A total of 14 of the 53 factors were common to both the Delphi survey and AHP with high weights. The most notable factors were prolonged treatment, experience of treatment failure, and unknown effects of medication. Conclusion: Through consensus decision-making by experts, 14 factors were identified as relevant factors associated with non-adherence to COPD self-management. A hierarchical and systematic framework incorporating factors associated with non-adherence to COPD self-management was developed in this study. Further research is needed to develop intervention strategies based on factors associated with non-adherence to COPD self-management.

Effectiveness of self-management programmes for heart failure with reduced ejection fraction: a systematic review protocol.

INTRODUCTION: Chronic disease self-management (CDSM) is a vital component of congestive heart failure (CHF) programmes. Recent CHF guidelines have downgraded CDSM programmes citing a lack of gold-standard evidence. This protocol describes the aims and methods of a systematic review to collate and synthesise the published research evidence to determine the effectiveness of CDSM programmes and interventions for patients treated for CHF. METHODS: Medline, PubMed, Embase, CENTRAL, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO, SCOPUS, Web of Science, the Science Citation Index and registers of clinical trials will be searched from 1966 to 2024. In addition, the reference lists of shortlisted articles will be reviewed. Randomised controlled trials, with case management interventions of CDSM and CHF with reported major adverse cardiovascular events (MACEs), will be extracted and analysed. There is no restriction on language. Study protocol template developed from Cochrane Collaboration and Reporting adheres to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines for systematic review and meta-analyses 2020. Two independent authors will apply inclusions and exclusion criteria to limit article search and assess bias and certainty of evidence rating. Data extraction and study description of included studies will include quality appraisal of studies and quantitative synthesis of data will then be undertaken to ascertain evidence for the study aims. Subgroup analyses will be conducted for different CDSM programmes. The primary outcome will be a significant change in MACE parameters between intervention and control arms. Meta-analysis will be conducted using statistical software, if feasible. ETHICS AND DISSEMINATION: Ethics approval is not sought as the study is not collecting primary patient data. The results of this study will be disseminated through peer-reviewed scientific journals and also presented to audiences through meetings and scientific conferences. PROSPERO REGISTRATION NUMBER: CRD42023431539.

Development of an epilepsy self-management mobile health app framework: Content validity study results.

BACKGROUND: Mobile health (mHealth) applications (apps) show promise in supporting epilepsy self-management (eSM). To delve deeper into this potential, we conducted a systematic review of epilepsy mHealth apps available on both iOS and Android platforms, examining articles related to eSM. This review allowed us to identify important domains related to eSM. Furthermore, based on the findings, we developed an epilepsy mHealth app framework that aims to improve self-management for the local population. This study aims to assess the practicality and usability of the proposed mHealth app framework designed to improve eSM. We will conduct an expert panel review to evaluate the effectiveness and feasibility of the framework. MATERIAL AND METHODS: Content validity was assessed by an expert panel comprising epileptologists and pharmacists. The validation process involved scoring the items within each domain of the framework to evaluate their practicality and usability (quantitative component). In addition, a panel discussion was conducted to further explore and discuss the qualitative aspects of the items. RESULTS: A total of 4 domains with 15 items were highly rated for their practicality and usefulness in eSM. CONCLUSIONS: The locally validated framework will be useful for developing eSM mobile apps. Seizure Tracking, Medication Adherence, Treatment Management, and Healthcare Communication emerged as the most crucial domains for enhancing eSM.

Motivational Interviewing With Pender's Health Promotions Model: Diabetics Self-Management Behavior.

The purpose of the study was to determine the effects of motivational interviewing as based on Pender's health promotion model (HPM) on diabetes self-management behavior among individuals with Type 2 diabetes. Apart from their routine care, the individuals in the intervention group were given a 30-45-minute motivational interview based on Pender's HPM once a week for three months. Statistically significant differences were determined between the groups in the total score of the scales and its sub-dimensions (p < .05). The intervention applied in the present study can be used as an effective and easy method through which to develop and maintain diabetes self-management behaviors.

The Effect of Nursing Approach on the Self-Management and Adjustment to the Illness among Newly Diagnosed Diabetic Patients According to Meleis's Transition Theory.

This study aimed to determine how the nursing approach based on Meleis's transition theory affects the self-management and adjustment to the illness among newly diagnosed diabetic patients. The study was conducted as one-group and pretest-posttest quasi-experimental design. The data were collected using the Introductory Questionnaire, the Diabetes Self-Management Questionnaire (DSMQ), and the Psychosocial Adjustment to Illness Scale-Self Report (PAIS-SR). It was determined that there was a positive increase in the total score of the DSMQ after the intervention, and a positive decrease in the total score of the PAIS-SR, and the difference between the scores were statistically significant (p < .05).

[New educational approaches to the patient. A scoping review of systematic reviews.] / Gamification: un nuovo approccio educativo al paziente. Una scoping review di revisioni sistematiche.

INTRODUCTION: New educational approaches are emerging to assist healthcare professionals in better personalizing patient's educational pathways. Specifically, "gamification" - the incorporation of game elements into non-game contexts - appears to be a novel and affordable approach. This scoping review aims to explore and map the literature that evaluates the efficacy of gamification in healthcare contexts. METHODS: A scoping review of reviews was conducted in MEDLINE, CINAHL, and PsycINFO using the JBI Manual for Evidence Synthesis guidelines and the PRISMA ScR checklist. RESULTS: A total of four systematic reviews and four meta-analyses were included. It appears that gamification, when used in conjunction with other conventional educational tools, improves physical activity, facilitates better self-management of type 2 diabetes, improves cognitive functions, and improves the quality of life, particularly among specific groups like the elderly. DISCUSSIONS: Gamification is an innovative educational approach that could be useful in patient's educational pathways. However, it seems that gamification is effective only in particular subgroups, and therefore the generalization of the results should also be assessed with caution due to the high risk of bias in the included studies and the small sample sizes considered. CONCLUSION: More randomized controlled trials and meta-analysis studies should be conducted to better understand the role and efficacy of gamification in patient education.

Effectiveness of the Green Heart Smartphone Application as a Self-Management Intervention for Hypertension and Dyslipidemia: A Randomized Clinical Trial.

BACKGROUND: Cardiovascular disease (CVD) is a major global health concern, the leading cause of death and disability. Thus, preventive interventions targeting modifiable risk factors are essential. Mobile-health technologies have emerged as promising tools for improving prevention by modifying risk factors. We created the "Green Heart" mobile app to help coronary artery disease (CAD) patients control their risk factors. The app has three modules: smoking cessation, dyslipidemia (DLP) control, and blood pressure (BP) management. This study evaluated the app's performance in monitoring hypertension (HTN) and DLP among known CAD cases. METHODS: A randomized controlled trial enrolled 1590 CAD subjects, including 1114 hypertensive patients and 1488 subjects with DLP, and assigned them randomly to paper-based education or application-based groups. RESULTS: Regarding HTN, after 6 months, we finally analyzed 545 and 546 hypertensive patients, assigned to the conventional and app groups, respectively. Patients in the app group were more likely to have their BP managed successfully (88.6% vs. 78.5%; P<0.001). The app group showed higher odds of successful BP management (odds ratio [OR]: 2.13; 95% CI: 1.51 - 3.03). Regarding DLP, we analyzed 728 patients in the conventional and 714 patients in the app group. A higher percentage of patients in the app group (24.8%) had low-density lipoprotein cholesterol (LDL-C) levels less than 70 mg/dL (16.1%; P<0.001). The app group showed higher odds of reducing LDL-C (OR: 1.72; 95% CI: 1.32-2.26). CONCLUSION: We found that using the Green Heart app in the self-monitoring setting significantly improved BP and DLP management across the study population.

Resilience and Self-Management of Hypertension in African American Adults Using a Conceptualized Resilience Framework: An Exploratory Analysis.

BACKGROUND: Hypertension rates have increased worldwide, with the most significant increase in morbidity and mortality observed among African Americans. Resilience is a potential factor influencing how individuals manage health-related challenges or self-management tasks for hypertension. Research is scarce related to resilience and self-management frameworks in African Americans with hypertension. OBJECTIVES: We aimed to describe a conceptualized resilience framework and preliminary findings of the association among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes in African Americans with hypertension. METHODS: This cross-sectional, descriptive-correlational study included African American adults with hypertension, aged 25 years and older, recruited from an academic university and surrounding urban communities in the Midwest. Participants completed standardized, validated questionnaires to examine the association among resilience precursors, stress response, hypertension self-management behaviors, health-related quality of life (HRQOL), and blood pressure at baseline. Descriptive statistics were used to describe the sample demographic characteristics, whereas Pearson's correlational and multiple regression analyses were conducted to determine the associations among the variables. RESULTS: African Americans with hypertension (N = 30) were included in this preliminary study, with a mean age of 59.17 years; 66.7% were female. The mean systolic blood pressure was 136 (SD = 16.8) mmHg; the mean diastolic blood pressure was 78.1 (SD = 13) mmHg. Pearson's correlation analysis revealed significant relationships between resilience precursors, stress response, hypertension self-management behaviors and capability, and health outcome components. Multiple regression analysis showed that poor perceived resilience significantly predicted depression. Low dispositional optimism and low perceived resilience were significant predictors of stress. Higher perceived resilience significantly predicted self-efficacy. Perceived stress was negatively and significantly associated with HRQOL. Finally, higher self-efficacy significantly predicted better HRQOL. DISCUSSION: This study underscores the significant association between resilience, stress, self-management behaviors, and health outcomes in African Americans with hypertension. Further research with larger sample sizes and longitudinal designs is warranted to confirm and expand upon these findings.

Barriers and facilitators to engaging with a digital self-management programme for painful distal upper limb musculoskeletal disorders: A qualitative exploratory study.

INTRODUCTION: People living with a painful distal upper limb musculoskeletal disorder (DUL-MSD) often experience pain, difficulty in doing everyday tasks and a reduced quality of life. Currently, there are challenges in the treatment of DUL-MSDs, highlighting the need to develop innovative approaches to rehabilitation. A potential solution is to develop and implement a digital self-management rehabilitation programme focussing on optimising recovery, improving function and reducing pain. Before developing this programme, we aimed to identify the barriers and facilitators to using a digital health intervention (DHI) for self-management of DUL-MSDs. OBJECTIVE: This study aimed to investigate the potential barriers and facilitators to using a DHI with people living with DUL-MSDs and healthcare professionals (HCPs). METHODS: A qualitative exploratory study was carried out with purposely selected participants consisting of 15 participants with DUL-MSDs and 13 HCPs. Three focus groups (FGs) and four semistructured interviews with DUL-MSD participants and semistructured interviews with 13 HCPs were conducted. FGs and interviews were digitally recorded, transcribed and analysed using reflexive thematic analysis. RESULTS: To address challenges in the care and management of DUL-MSDs, both HCPs and people living with a DUL-MSD welcomed the development of a DHI. This study identified several barriers and facilitators that would influence engagement with a digital intervention. Findings suggest that in developing a DHI, attention needs to be paid to digital design features, usability, tailoring, personalisation and consideration of how well usual care could be replicated digitally without direct HCP involvement. CONCLUSION: The identified digital design features of importance to participants will inform the design of a digital self-management rehabilitation programme for people living with DUL-MSDs. Addressing the barriers and facilitators to engagement with a DHI is essential in ensuring its relevance and acceptability to those who will use it. PATIENT OR PUBLIC CONTRIBUTION: Patient and Public Involvement and Engagement (PPIE) was integral throughout the study. PPIE members contributed to the development and planning of this study, checked and confirmed the relevance of the findings and are involved in the dissemination plans.

Understanding the processes underpinning IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a process evaluation within a cluster randomised controlled implementation trial.

BACKGROUND: Providing supported self-management for people with asthma can reduce the burden on patients, health services and wider society. Implementation, however, remains poor in routine clinical practice. IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) is a UK-wide cluster randomised implementation trial that aims to test the impact of a whole-systems implementation strategy, embedding supported asthma self-management in primary care compared with usual care. To maximise opportunities for sustainable implementation beyond the trial, it is necessary to understand how and why the IMP2ART trial achieved its clinical and implementation outcomes. METHODS: A mixed-methods process evaluation nested within the IMP2ART trial will be undertaken to understand how supported self-management was implemented (or not) by primary care practices, to aid interpretation of trial findings and to inform scaling up and sustainability. Data and analysis strategies have been informed by mid-range and programme-level theory. Quantitative data will be collected across all practices to describe practice context, IMP2ART delivery (including fidelity and adaption) and practice response. Case studies undertaken in three to six sites, supplemented by additional interviews with practice staff and stakeholders, will be undertaken to gain an in-depth understanding of the interaction of practice context, delivery, and response. Synthesis, informed by theory, will combine analyses of both qualitative and quantitative data. Finally, implications for the scale up of asthma self-management implementation strategies to other practices in the UK will be explored through workshops with stakeholders. DISCUSSION: This mixed-methods, theoretically informed, process evaluation seeks to provide insights into the delivery and response to a whole-systems approach to the implementation of supported self-management in asthma care in primary care. It is underway at a time of significant change in primary care in the UK. The methods have, therefore, been developed to be adaptable to this changing context and to capture the impact of these changes on the delivery and response to research and implementation processes.