A Smart Mobile Health Tool Versus a Paper Action Plan to Support Self-Management of Chronic Obstructive Pulmonary Disease Exacerbations: Randomized Controlled Trial.
ABSTRACT: BACKGROUND:Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs. OBJECTIVE:This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals. METHODS:In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models. RESULTS:Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good. CONCLUSIONS:This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan. TRIAL REGISTRATION:ClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.
Project description:BACKGROUND:Self-management of exacerbations in COPD patients is important to reduce exacerbation impact. There is a need for more comprehensive and individualized interventions to improve exacerbation-related self-management behavior. The use of mobile health (mHealth) could help to achieve a wide variety of behavioral goals. Understanding of patients and health care providers perspectives towards using mHealth in promoting self-management will greatly enhance the development of solutions with optimal usability and feasibility. Therefore, the aim of this study was to explore perceptions of COPD patients and their health care providers towards using mHealth for self-management of exacerbations. METHODS:A qualitative study using focus group interviews with COPD patients (n?=?13) and health care providers (HCPs) (n?=?6) was performed to explore perceptions towards using mHealth to support exacerbation-related self-management. Data were analyzed by a thematic analysis. RESULTS:COPD patients and HCPs perceived mostly similar benefits and barriers of using mHealth for exacerbation-related self-management. These perceived benefits and barriers seem to be important drivers in the willingness to use mHealth. Both patients and HCPs strengthen the need for a multi-component and tailored mHealth intervention that improves patients' exacerbation-related self-management by determining their health status and providing adequate information, decision support and feedback on self-management behavior. Most importantly, patients and HCPs considered an mHealth intervention as support to improve self-management and emphasized that it should never replace patients' own feelings nor undermine their own decisions. In addition, the intervention should be complementary to regular contact with HCPs, as personal contact with a HCP was considered to be very important. To optimize engagement with mHealth, patients should have a positive attitude toward using mHealth and an mHealth intervention should be attractive, rewarding and safe. CONCLUSIONS:This study provided insight into perceptions of COPD patients and their HCPs towards using mHealth for self-management of exacerbations. This study points out that future mHealth interventions should focus on developing self-management skills over time by providing adequate information, decision support and feedback on self-management behavior and that mHealth should complement regular care. To optimize engagement, mHealth interventions should be attractive, rewarding, safe and tailored to the patient needs.
Project description:BACKGROUND:Adequate self-management skills are of great importance for patients with chronic obstructive pulmonary disease (COPD) to reduce the impact of COPD exacerbations. Using mobile health (mHealth) to support exacerbation-related self-management could be promising in engaging patients in their own health and changing health behaviors. However, there is limited knowledge on how to design mHealth interventions that are effective, meet the needs of end users, and are perceived as useful. By following an iterative user-centered design (UCD) process, an evidence-driven and usable mHealth intervention was developed to enhance exacerbation-related self-management in patients with COPD. OBJECTIVE:This study aimed to describe in detail the full UCD and development process of an evidence-driven and usable mHealth intervention to enhance exacerbation-related self-management in patients with COPD. METHODS:The UCD process consisted of four iterative phases: (1) background analysis and design conceptualization, (2) alpha usability testing, (3) iterative software development, and (4) field usability testing. Patients with COPD, health care providers, COPD experts, designers, software developers, and a behavioral scientist were involved throughout the design and development process. The intervention was developed using the behavior change wheel (BCW), a theoretically based approach for designing behavior change interventions, and logic modeling was used to map out the potential working mechanism of the intervention. Furthermore, the principles of design thinking were used for the creative design of the intervention. Qualitative and quantitative research methods were used throughout the design and development process. RESULTS:The background analysis and design conceptualization phase resulted in final guiding principles for the intervention, a logic model to underpin the working mechanism of the intervention, and design requirements. Usability requirements were obtained from the usability testing phases. The iterative software development resulted in an evidence-driven and usable mHealth intervention-Copilot, a mobile app consisting of a symptom-monitoring module, and a personalized COPD action plan. CONCLUSIONS:By following a UCD process, an mHealth intervention was developed that meets the needs and preferences of patients with COPD, is likely to be used by patients with COPD, and has a high potential to be effective in reducing exacerbation impact. This extensive report of the intervention development process contributes to more transparency in the development of complex interventions in health care and can be used by researchers and designers as guidance for the development of future mHealth interventions.
Project description:Exacerbations of chronic obstructive pulmonary disease (COPD) are associated with significant morbidity and mortality, and treatments require a multidisciplinary approach to address patient needs. This review considers different models of care across the continuum of exacerbations (1) chronic care and self-management interventions with the action plan, (2) domiciliary care for severe exacerbation and the impact on readmission prevention and (3) the discharge care bundle for management beyond the acute exacerbation episode. Self-management strategies include written action plans and coaching with patient and family support. Self-management interventions facilitate the delivery of good care, can reduce exacerbations associated with admission, be cost-effective and improve quality of life. Hospitalization as a complication of exacerbation is not always unavoidable. Domiciliary care has been proposed as a solution to replace part, and perhaps even all, of the patient's in-hospital stay, and to reduce hospital bed days, readmission rates and costs; low-risk patients can be identified using risk stratification tools. A COPD discharge bundle is another potentially important approach that can be considered to improve the management of COPD exacerbations complicated by hospital admission; it comprised treatments that have demonstrated efficacy, such as smoking cessation, personalized pharmacotherapy and non-pharmacotherapy such as pulmonary rehabilitation. COPD bundles may also improve the transition of care from the hospital to the community following exacerbation and may reduce readmission rates. Future models of care should be personalized - providing patient education aiming at behaviour changes, identifying and treating co-morbidities, and including outcomes that measure quality of care rather than focusing only on readmission quantity within 30 days.
Project description:INTRODUCTION:Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death globally. In outpatient care, the self-management of COPD is essential, but patient adherence to this remains suboptimal. The objective of this study is to examine whether an innovative mobile health (mHealth)-enabled care programme (MH-COPD) will improve the patient self-management and relevant health outcomes. METHODS AND ANALYSIS:A prospective open randomised controlled trial has been designed. In the trial, patients with COPD will be recruited from The Prince Charles Hospital, Brisbane, Australia. They will then be randomised to participate in either the MH-COPD intervention group (n=50 patients), or usual care control group (UC-COPD) (n=50 patients) for 6 months. The MH-COPD programme has been designed to integrate an mHealth system within a clinical COPD care service. In the programme, participants will use a mHealth application at home to review educational videos, monitor COPD symptoms, use an electronic action plan, modify the risk factors of cigarette smoking and regular physical activity, and learn to use inhalers optimally. All participants will be assessed at baseline, 3 months and 6 months. The primary outcomes will be COPD symptoms and quality of life. The secondary outcomes will be patient adherence, physical activity, smoking cessation, use of COPD medicines, frequency of COPD exacerbations and hospital readmissions, and user experience of the mobile app. ETHICS AND DISSEMINATION:The clinical trial has been approved by The Prince Charles Hospital Human Research Ethics Committee (HREC/16/QPCH/252). The recruitment and follow-up of the trial will be from January 2019 to December 2020. The study outcomes will be disseminated according to the Consolidated Standards of Reporting Trials statement through a journal publication, approximately 6 months after finishing data collection. TRIAL REGISTRATION NUMBER:ACTRN12618001091291.
Project description:<h4>Background</h4>Mobile health (mHealth) technology is an increasingly recognized and effective method for disease management and has the potential to intervene in pulmonary function, exacerbation risk, and psychological status of patients with chronic obstructive pulmonary disease (COPD).<h4>Objective</h4>This study aimed to investigate the feasibility of an mHealth-based COPD management system designed for Chinese remote areas with many potential COPD patients but limited medical resources.<h4>Methods</h4>The system was implemented based on a tailored closed-loop care pathway that breaks the heavy management tasks into detailed pieces to be quantified and executed by computers. Low-cost COPD evaluation and questionnaire-based psychological intervention are the 2 main characteristics of the pathway. A 6-month prospective observational study at the community level was performed to evaluate the effect of the system. Primary outcomes included changes in peak expiratory flow values, quality of life measured using the COPD assessment test scale, and psychological condition. Acute exacerbations, compliance, and adverse events were also measured during the study. Compliance was defined as the ratio of the actual frequency of self-monitoring records to the prescribed number.<h4>Results</h4>A total of 56 patients was enrolled; 39 patients completed the 6-month study. There was no significant difference in the mean peak expiratory flow value before and after the 6-month period (366.1, SD 106.7 versus 313.1, SD 116.6; P=.11). Psychological condition significantly improved after 6 months, especially for depression, as measured using the Patient Health Questionnaire-9 scale (median 6.0, IQR 3.0-9.0 versus median 4.0, IQR 0.0-6.0; P=.001). The COPD assessment test score after 6 months of intervention was also lower than that at the baseline, and the difference was significant (median 4.0, IQR 1.0-6.0 versus median 3.0, IQR 0.0-6.0; P=.003). The median overall compliance was 91.1% (IQR 67%-100%). In terms of acute exacerbation, 110 exacerbations were detected and confirmed by health care providers (per 6 months, median 2.0, IQR 1.0-5.0). Moreover, 72 adverse events occurred during the study, including 1 death, 19 hospitalizations, and 52 clinic visits due to persistent respiratory symptoms.<h4>Conclusions</h4>We designed and validated a feasible mHealth-based method to manage COPD in remote Chinese areas with limited medical resources. The proposed closed-loop care pathway was effective at the community level. Proper education and frequent communication with health care providers may encourage patients' acceptance and use of smartphones to support COPD self-management. In addition, WeChat might play an important role in improving patient compliance and psychological distress. Further research might explore the effect of such systems on a larger scale and at a higher evidence level.
Project description:Exacerbations of COPD are one of the commonest causes of admission and readmission to hospital. The role of digital interventions to support self-management in improving outcomes is uncertain. We conducted an open, randomised controlled trial of a digital health platform application (app) in 41 COPD patients recruited following hospital admission with an acute exacerbation. Subjects were randomised to either receive usual care, including a written self-management plan (<i>n</i>?=?21), or the myCOPD app (<i>n</i>?=?20) for 90 days. The primary efficacy outcome was recovery rate of symptoms measured by COPD assessment test (CAT) score. Exacerbations, readmission, inhaler technique quality of life and patient activation (PAM) scores were also captured by a blinded team. The app was acceptable in this care setting and was used by 17 of the 20 patients with sustained use over the study period. The treatment effect on the CAT score was 4.49 (95% CI: -8.41, -0.58) points lower in the myCOPD arm. Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors). Exacerbations tended to be less frequent in the digital arm compared to usual care; 34 vs 18 events. Hospital readmissions risk was numerically lower in the digital intervention arm: OR for readmission 0.383 (95% CI: 0.074, 1.987; <i>n</i>?=?35). In this feasibility study of the digital self-management platform myCOPD, the app has proven acceptable to patients to use and use has improved exacerbation recovery rates, with strong signals of lower re-exacerbation and readmission rates over 90 days. myCOPD reduced the number of critical errors in inhaler technique compared to usual care with written self-management. This provides a strong basis for further exploration of the use of app interventions in the context of recently hospitalised patients with COPD and informs the potential design of a large multi-centre trial.
Project description:Rationale: Although chronic obstructive pulmonary disease (COPD) exacerbation frequency is stable in research cohorts, whether severe COPD exacerbation frequency can be used to identify patients at high risk for future severe COPD exacerbations and/or mortality is unknown. Methods: Severe COPD exacerbation frequency stability was determined in 3 distinct clinical cohorts. A total of 17,450 patients with COPD in Intermountain Healthcare were categorized based on the number of severe COPD exacerbations per year. We determined whether exacerbation frequency was stable and whether it predicted mortality. These findings were validated in 83,134 patients from the U.S. Veterans Affairs (VA) nationwide health care system and 3326 patients from the University of Chicago Medicine health system. Results: In the Intermountain Healthcare cohort, the majority (84%, 14,706 patients) had no exacerbations in 2009 and were likely to remain non-exacerbators with a significantly lower 6-year mortality compared with frequent exacerbators (2 or more exacerbations per year) (25% versus 57%, p<0.001). Similar findings were noted in the VA health system and the University of Chicago Medicine health system. Non-exacerbators were likely to remain non-exacerbators with the lowest overall mortality. In all cohorts, frequent exacerbator was not a stable phenotype until patients had at least 2 consecutive years of frequent exacerbations. COPD exacerbation frequency predicted any cause mortality. Conclusions: In clinical datasets across different organizations, severe COPD exacerbation frequency was stable after at least 2 consecutive years of frequent exacerbations. Thus, severe COPD exacerbation frequency identifies patients across a health care system at high risk for future COPD-related health care utilization and overall mortality.
Project description:Background:To support patients with COPD in their self-management of symptom worsening, we developed Adaptive Computerized COPD Exacerbation Self-management Support (ACCESS), an innovative software application that provides automated treatment advice without the interference of a health care professional. Exacerbation detection is based on 12 symptom-related yes-or-no questions and the measurement of peripheral capillary oxygen saturation (SpO2), forced expiratory volume in one second (FEV1), and body temperature. Automated treatment advice is based on a decision model built by clinical expert panel opinion and Bayesian network modeling. The current paper describes the validity of ACCESS. Methods:We performed secondary analyses on data from a 3-month prospective observational study in which patients with COPD registered respiratory symptoms daily on diary cards and measured SpO2, FEV1, and body temperature. We examined the validity of the most important treatment advice of ACCESS, ie, to contact the health care professional, against symptom- and event-based exacerbations. Results:Fifty-four patients completed 2,928 diary cards. One or more of the different pieces of ACCESS advice were provided in 71.7% of all cases. We identified 115 symptom-based exacerbations. Cross-tabulation showed a sensitivity of 97.4% (95% CI 92.0-99.3), specificity of 65.6% (95% CI 63.5-67.6), and positive and negative predictive value of 13.4% (95% CI 11.2-15.9) and 99.8% (95% CI 99.3-99.9), respectively, for ACCESS' advice to contact a health care professional in case of an exacerbation. Conclusion:In many cases (71.7%), ACCESS gave at least one self-management advice to lower symptom burden, showing that ACCES provides self-management support for both day-to-day symptom variations and exacerbations. High sensitivity shows that if there is an exacerbation, ACCESS will advise patients to contact a health care professional. The high negative predictive value leads us to conclude that when ACCES does not provide the advice to contact a health care professional, the risk of an exacerbation is very low. Thus, ACCESS can safely be used in patients with COPD to support self-management in case of an exacerbation.
Project description:Introduction:Self-management interventions with Written Action Plans and case management support have been shown to improve outcomes in patients with chronic obstructive pulmonary disease (COPD). Novel telehealth technologies may improve self-management interventions. The objectives of this study were to determine whether the use of an interactive phone telesystem increases Action Plan adherence, improves exacerbation recovery and reduces healthcare use in a real-life practice of a COPD clinic. Methods:Initially, 40 patients were followed by a COPD telesystem for 1 year. Detailed data from patients' behaviours during exacerbations was recorded. The telesystem use was then extended to 256 patients from a real-life COPD clinic. Healthcare utilisation for the year before and after telesystem enrolment was then assessed through hospital administrative databases. Results:Thirty-three of the 40 patients completed the initial 1-year study. Eighty-one exacerbations were reported in the 1-year follow-up. Action Plan adherence was observed for 72% of the exacerbations and those who were adherent had a significantly faster exacerbation recovery time. The large-scale implementation of the telesystem resulted in a significant decrease in the proportion of patients with ≥1 respiratory-related emergency room (ER) visits (120 before vs 110 after enrolment, p<0.001) and with ≥1 COPD-related hospitalisations (75 before vs 65 after enrolment, p<0.001). Discussion:COPD Written Action Plan adherence was further enhanced with the use of telehealth technologies in a specialised clinic with experience in COPD self-management. Patients followed by the telesystem recovered faster from exacerbations and had a further decrease in COPD-related ER visits and hospitalisations. Trial registration number:NCT02275078.
Project description:Chronic obstructive pulmonary disease (COPD) prevalence in Canada has risen over time. COPD-related exacerbations contribute to the increased health care utilization (HCU) in this population. This study investigated the impact of exacerbations on COPD-related HCU.This retrospective observational cohort study used patient data from the Québec provincial health insurance databases. Eligible patients with a new HCU claim with a diagnostic billing for COPD during 2001-2010 were followed until March 31, 2011. Exacerbation rates and time to first exacerbation were assessed. Unadjusted analyses and multivariable models compared the rate of HCU by exacerbation classification (any [moderate/severe], moderate, or severe).The exacerbation event rate in patients with an exacerbation was 34.3 events/100 patient-years (22.7 for moderate exacerbations and 11.6 for severe exacerbations). Median time to first exacerbation of any classification was 37 months. In unadjusted analyses, COPD-related HCU significantly increased with exacerbation severity. In the multivariable, HCU rates were significantly higher after exacerbation versus before exacerbation (p < 0.01) for patients with an exacerbation or moderate exacerbations. For severe exacerbations, general practitioner, respiratory specialist, emergency room, and hospital visits were significantly higher after exacerbation versus before exacerbation (p < 0.001).Exacerbations were associated with increased HCU, which was more pronounced for patients with severe exacerbations. Interventions to reduce the risk of exacerbations in patients with COPD may reduce disease burden.