Using a mobile health application to support self-management in COPD: a qualitative study

Background

Telehealth shows promise for supporting patients in managing their long-term health conditions, such as chronic obstructive pulmonary disease (COPD). However, it is currently unclear how patients, and particularly older people, may benefit from these technological interventions.

Aim

To explore patients’ expectations and experiences of using a mobile telehealth-based (mHealth) application and to determine how such a system may impact on their perceived wellbeing and ability to manage their COPD.

Design and setting

Embedded qualitative study using interviews with patients with COPD from various community NHS services: respiratory community nursing service, general practice, and pulmonary rehabilitation.

Method

An embedded qualitative study was conducted to which patients were recruited using purposive sampling to achieve maximum variation. Interviews were carried out prior to receiving the mHealth system and again after a 6-month period. Data were analysed using a grounded theory approach.

Results

The sample comprised 19 patients (aged 50–85 years) with varied levels of computer skills. Patients identified no difficulties in using the mHealth application. The main themes encapsulating patients’ experience of using the mHealth application related to an increased awareness of the variability of their symptoms (onset of exacerbation and recovery time) and reassurance through monitoring (continuity of care).

Conclusion

Patients were able to use the mHealth application, interpret clinical data, and use these within their self-management approach regardless of previous knowledge. Telehealth interventions can complement current clinical care pathways to support self-management behaviour.     

Issues in mHealth: Findings From Key Informant Interviews

Background

mHealth is enjoying considerable interest and private investment in the United States. A small but growing body of evidence indicates some promise in supporting healthy behavior change and self-management of long-term conditions. The unique benefits mobile phones bring to health initiatives, such as direct access to health information regardless of time or location, may create specific issues for the implementation of such initiatives. Other issues may be shared with general health information technology developments.

Objective

To determine the important issues facing the implementation of mHealth from the perspective of those within the US health system and those working in mHealth in the United States.

Methods

Semistructured interviews were conducted with 27 key informants from across the health and mHealth sectors in the United States. Interviewees were approached directly following an environmental scan of mHealth in the United States or recommendation by those working in mHealth.

Results

The most common issues were privacy and data security, funding, a lack of good examples of the efficacy and cost effectiveness of mHealth in practice, and the need for more high-quality research. The issues are outlined and categorized according to the environment within which they predominantly occur: policy and regulatory environments; the wireless industry; the health system; existing mHealth practice; and research.

Conclusions

Many of these issues could be addressed by making the most of the current US health reform environment, developing a strategic and coordinated approach, and seeking to improve mHealth practice.     

The Role of Mobile Technologies in Health Care Processes: The Case of Cancer Supportive Care

Background

Health care systems are gradually moving toward new models of care based on integrated care processes shared by different care givers and on an empowered role of the patient. Mobile technologies are assuming an emerging role in this scenario. This is particularly true in care processes where the patient has a particularly enhanced role, as is the case of cancer supportive care.

Objective

This paper aims to review existing studies on the actual role and use of mobile technology during the different stages of care processes, with particular reference to cancer supportive care.

Methods

We carried out a review of literature with the aim of identifying studies related to the use of mHealth in cancer care and cancer supportive care. The final sample size consists of 106 records.

Results

There is scant literature concerning the use of mHealth in cancer supportive care. Looking more generally at cancer care, we found that mHealth is mainly used for self-management activities carried out by patients. The main tools used are mobile devices like mobile phones and tablets, but remote monitoring devices also play an important role. Text messaging technologies (short message service, SMS) have a minor role, with the exception of middle income countries where text messaging plays a major role. Telehealth technologies are still rarely used in cancer care processes. If we look at the different stages of health care processes, we can see that mHealth is mainly used during the treatment of patients, especially for self-management activities. It is also used for prevention and diagnosis, although to a lesser extent, whereas it appears rarely used for decision-making and follow-up activities.

Conclusions

Since mHealth seems to be employed only for limited uses and during limited phases of the care process, it is unlikely that it can really contribute to the creation of new care models. This under-utilization may depend on many issues, including the need for it to be embedded into broader information systems. If the purpose of introducing mHealth is to promote the adoption of integrated care models, using mHealth should not be limited to some activities or to some phases of the health care process. Instead, there should be a higher degree of pervasiveness at all stages and in all health care delivery activities.     

The Performance of mHealth in Cancer Supportive Care: A Research Agenda

Background

Since the advent of smartphones, mHealth has risen to the attention of the health care system as something that could radically change the way health care has been viewed, managed, and delivered to date. This is particularly relevant for cancer, as one of the leading causes of death worldwide, and for cancer supportive care, since patients and caregivers have key roles in managing side effects. Given adequate knowledge, they are able to expect appropriate assessments and interventions. In this scenario, mHealth has great potential for linking patients, caregivers, and health care professionals; for enabling early detection and intervention; for lowering costs; and achieving better quality of life. Given its great potential, it is important to evaluate the performance of mHealth. This can be considered from several perspectives, of which organizational performance is particularly relevant, since mHealth may increase the productivity of health care providers and as a result even the productivity of health care systems.

Objective

This paper aims to review studies on the evaluation of the performance of mHealth, with particular focus on cancer care and cancer supportive care processes, concentrating on its contribution to organizational performance, as well as identifying some indications for a further research agenda.

Methods

We carried out a review of literature, aimed at identifying studies related to the performance of mHealth in general or focusing on cancer care and cancer supportive care.

Results

Our analysis revealed that studies are almost always based on a single dimension of performance. Any evaluations of the performance of mHealth are based on very different methods and measures, with a prevailing focus on issues linked to efficiency. This fails to consider the real contribution that mHealth can offer for improving the performance of health care providers, health care systems, and the quality of life in general.

Conclusions

Further research should start by stating and explaining what is meant by the evaluation of mHealth’s performance and then conduct more in-depth analysis in order to create shared frameworks to specifically identify the different dimensions of mHealth’s performance.     

Improving Diabetes Management With a Patient Portal: Qualitative Study of a Diabetes Self-Management Portal

Background

Effective management and care of diabetes is crucial to reducing associated risks such as heart disease and kidney failure. With increasing access and use of the Internet, online chronic disease management is being explored as a means of providing patients with support and the necessary tools to monitor and manage their disease.

Objective

The objective of our study was to evaluate the experience of patients and providers using an online diabetes management portal for patients.

Methods

Participants were recruited from a large sample population of 887 for a follow-up questionnaire to be completed after 6 months of using the patient portal. Participants were presented with the option to participate in an additional interview and, if the participant agreed, a time and date was scheduled for the interview. A 5-item, open-ended questionnaire was used to capture providers'' opinions of the patient portal. Providers included general practitioners (GPs), nurses, nurse practitioners (NPs), dieticians, diabetes educators (DECs), and other clinical staff.

Results

A total of 854 patients were consented for the questionnaire. Seventeen (8 male, 9 female) patients agreed to participate in a telephone interview. Sixty-four health care providers completed the five open-ended questions; however, an average of 48.2 responses were recorded per question. Four major themes were identified and will be discussed in this paper. These themes have been classified as: facilitators of disease management, barriers to portal use, patient-provider communication and relationship, and recommendations for portal improvements.

Conclusions

This qualitative study shows that online chronic disease management portals increase patient access to information and engagement in their health care, but improvements in the portal itself may improve usability and reduce attrition. Furthermore, this study identifies a grey area that exists in the roles that GPs and AHPs should play in the facilitation of online disease management.     

The Invisible Work of Personal Health Information Management Among People With Multiple Chronic Conditions: Qualitative Interview Study Among Patients and Providers

Background

A critical problem for patients with chronic conditions who see multiple health care providers is incomplete or inaccurate information, which can contribute to lack of care coordination, low quality of care, and medical errors.

Objective

As part of a larger project on applications of consumer health information technology (HIT) and barriers to its use, we conducted a semistructured interview study with patients with multiple chronic conditions (MCC) with the objective of exploring their role in managing their personal health information.

Methods

Semistructured interviews were conducted with patients and providers. Patients were eligible if they had multiple chronic conditions and were in regular care with one of two medical organizations in New York City; health care providers were eligible if they had experience caring for patients with multiple chronic conditions. Analysis was conducted from a grounded theory perspective, and recruitment was concluded when saturation was achieved.

Results

A total of 22 patients and 7 providers were interviewed; patients had an average of 3.5 (SD 1.5) chronic conditions and reported having regular relationships with an average of 5 providers. Four major themes arose: (1) Responsibility for managing medical information: some patients perceived information management and sharing as the responsibility of health care providers; others—particularly those who had had bad experiences in the past—took primary responsibility for information sharing; (2) What information should be shared: although privacy concerns did influence some patients’ perceptions of sharing of medical data, decisions about what to share were also heavily influenced by their understanding of health and disease and by the degree to which they understood the health care system; (3) Methods and tools varied: those patients who did take an active role in managing their records used a variety of electronic tools, paper tools, and memory; and (4) Information management as invisible work: managing transfers of medical information to solve problems was a tremendous amount of work that was largely unrecognized by the medical establishment.

Conclusions

We conclude that personal health information management should be recognized as an additional burden that MCC places upon patients. Effective structural solutions for information sharing, whether institutional ones such as care management or technological ones such as electronic health information exchange, are likely not only to improve the quality of information shared but reduce the burden on patients already weighed down by MCC.     

Ethnic differences in primary care management of diabetes and cardiovascular disease in people with serious mental illness

Background

Patients with serious mental illness (SMI) have high rates of cardiovascular disease (CVD). In contrast to widespread perception, their access to effective chronic disease management is as high as for the general population. However, previous studies have not included analysis by ethnicity.

Aim

To identify differences in CVD and diabetes management, by ethnicity, among people with SMI.

Design and setting

Three inner east London primary care trusts with an ethnically diverse and socially deprived population. Data were obtained from 147 of 151 general practices.

Method

Coded demographic and clinical data were obtained from GP electronic health records using EMIS Web. The sample used was the GP registered population on diabetes or CVD registers (52 620); of these, 1223 also had SMI.

Results

The population prevalence of CVD and diabetes is 7.2%; this rises to 18% among those with SMI. People with SMI and CVD or diabetes were found to be as likely to achieve clinical targets as those without SMI. Blood pressure control was significantly better in people with SMI; however, they were more likely to smoke and have a body mass index above 30 kg/m². Ethnic differences in care were identified, with south Asian individuals achieving better cholesterol control and black African or Caribbean groups achieving poorer blood pressure control.

Conclusion

Risk factor management for those with SMI shows better control of blood pressure and glycosylated haemoglobin than the general population. However, smoking and obesity rates remain high and should be the target of public health programmes. Ethnic differences in management mirror those in the general population. Ethnic monitoring for vulnerable groups provides evidence to support schemes to reduce health inequalities.     

CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions

Background

Web-based and mobile health interventions (also called “Internet interventions” or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building.

Objective

To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions.

Methods

A literature review was conducted, followed by a survey among eHealth experts and a workshop.

Results

A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem.

Conclusions

CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.     

Burden of disease in Nari?o,Colombia, 2010

Objective:

This study sought to measure burden of disease and identifies health priorities from the Disability Adjusted Life Years (DALYs) indicator.

Methods:

This is the first study on burden of disease for a department in Colombia by using a standardized methodology. By using the

DALYs indicator, burden of disease was identified in the department of Nariño according to the guidelines established by the World Health Organization.

Results:

The DALYs in the Department of Nariño highlight the emergence of communicable, maternal, perinatal, and nutritional diseases during the first years of life; of accidents and lesions among youth, and non-communicable diseases in older individuals. Also, accidents and lesions are highlighted in men and non-communicable diseases in women.

Conclusions:

This study is part of the knowledge management process in the Departmental Health Plan for Nariño - Colombia 2012-2015 and contributes to the system of indicators of the 2012 ten-year public health plan. This research evidences that communicable diseases generate the biggest part of the burden of disease in the Department of Nariño, that DALYs due to non-communicable diseases are on the rise, and that accidents and lesions, especially due to violence are an important cause of DALYs in this region, which is higher than that of the country.     

Adherence in Internet Interventions for Anxiety and Depression: Systematic Review

Background

Open access websites which deliver cognitive and behavioral interventions for anxiety and depression are characterised by poor adherence. We need to understand more about adherence in order to maximize the impact of Internet-based interventions on the disease burden associated with common mental disorders.

Objective

The aims of this paper are to review briefly the adherence literature with respect to Internet interventions and to investigate the rates of dropout and compliance in randomized controlled trials of anxiety and depression Web studies.

Methods

A systematic review of randomized controlled trials using Internet interventions for anxiety and depression was conducted, and data was collected on dropout and adherence, predictors of adherence, and reasons for dropout.

Results

Relative to reported rates of dropout from open access sites, the present study found that the rates of attrition in randomized controlled trials were lower, ranging from approximately 1 - 50%. Predictors of adherence included disease severity, treatment length, and chronicity. Very few studies formally examined reasons for dropout, and most studies failed to use appropriate statistical techniques to analyze missing data.

Conclusions

Dropout rates from randomized controlled trials of Web interventions are low relative to dropout from open access websites. The development of theoretical models of adherence is as important in the area of Internet intervention research as it is in the behavioral health literature. Disease-based factors in anxiety and depression need further investigation.     

Satisfaction and adherence of patients with amputations to physiotherapy service at public hospitals in KwaZulu-Natal,South Africa

Background

Individuals who have undergone a lower limb amputation require comprehensive rehabilitation from the multidisciplinary team to ensure optimal treatment outcomes and social integration. Physiotherapists play a pivotal role within the multidisciplinary team and offer patients physical and psychosocial rehabilitative care. Determining patients'' satisfaction levels and exploring factors affecting adherence to physiotherapy interventions can inform practice and improve service delivery of rehabilitation within resource poor settings such as South Africa.

Objectives

To determine the level of satisfaction with physiotherapy services rendered to acute and sub-acute in-patients with lower limb amputations and to explore factors affecting adherence to physiotherapy intervention.

Methods

A prospective survey of 35 patients with lower limb amputations from four public hospitals in South Africa was undertaken. A modified version of the Hampstead rehabilitation centre patient satisfaction questionnaire was utilised.

Results

Majority of participants were satisfied with the physiotherapy services whilst a few reported dissatisfaction. Three themes emerged whilst exploring the patients'' experience relating to adherence to physiotherapy programmes. Themes included service delivery, patient-therapist interaction and participation barriers and facilitators.

Conclusion

Recommendations aimed to improve quality of care and healthcare outcomes thereby enhancing the participants'' adherence to the physiotherapy programme.     

The Impact of Electronic Patient Portals on Patient Care: A Systematic Review of Controlled Trials

Background

Modern information technology is changing and provides new challenges to health care. The emergence of the Internet and the electronic health record (EHR) has brought new opportunities for patients to play a more active role in his/her care. Although in many countries patients have the right to access their clinical information, access to clinical records electronically is not common. Patient portals consist of provider-tethered applications that allow patients to electronically access health information that are documented and managed by a health care institution. Although patient portals are already being implemented, it is still unclear in which ways these technologies can influence patient care.

Objective

To systematically review the available evidence on the impact of electronic patient portals on patient care.

Methods

A systematic search was conducted using PubMed and other sources to identify controlled experimental or quasi-experimental studies on the impact of patient portals that were published between 1990 and 2011. A total of 1,306 references from all the publication hits were screened, and 13 papers were retrieved for full text analysis.

Results

We identified 5 papers presenting 4 distinct studies. There were no statistically significant changes between intervention and control group in the 2 randomized controlled trials investigating the effect of patient portals on health outcomes. Significant changes in the patient portal group, compared to a control group, could be observed for the following parameters: quicker decrease in office visit rates and slower increase in telephone contacts; increase in number of messages sent; changes of the medication regimen; and better adherence to treatment.

Conclusions

The number of available controlled studies with regard to patient portals is low. Even when patient portals are often discussed as a way to empower patients and improve quality of care, there is insufficient evidence to support this assumption.     

The Effect of Patient Portals on Quality Outcomes and Its Implications to Meaningful Use: A Systematic Review

Background

The Health Information Technology for Economic and Clinical Health (HITECH) Act imposes pressure on health care organizations to qualify for “Meaningful Use”. It is assumed that portals should increase patient participation in medical decisions, but whether or not the use of portals improves outcomes remains to be seen.

Objective

The purpose of this systemic review is to outline and summarize study results on the effect of patient portals on quality, or chronic-condition outcomes as defined by the Agency for Healthcare Research and Quality, and its implications to Meaningful Use since the beginning of 2011. This review updates and builds on the work by Ammenwerth, Schnell-Inderst, and Hoerbst.

Methods

We performed a systematic literature search in PubMed, CINAHL, and Google Scholar. We identified any data-driven study, quantitative or qualitative, that examined a relationship between patient portals, or patient portal features, and outcomes. We also wanted to relate the findings back to Meaningful Use criteria. Over 4000 articles were screened, and 27 were analyzed and summarized for this systematic review.

Results

We identified 26 studies and 1 review, and we summarized their findings and applicability to our research question. Very few studies associated use of the patient portal, or its features, to improved outcomes; 37% (10/27) of papers reported improvements in medication adherence, disease awareness, self-management of disease, a decrease of office visits, an increase in preventative medicine, and an increase in extended office visits, at the patient’s request for additional information. The results also show an increase in quality in terms of patient satisfaction and customer retention, but there are weak results on medical outcomes.

Conclusions

The results of this review demonstrate that more health care organizations today offer features of a patient portal than in the review published in 2011. Articles reviewed rarely analyzed a full patient portal but instead analyzed features of a portal such as secure messaging, as well as disease management and monitoring. The ability of patients to be able to view their health information electronically meets the intent of Meaningful Use, Stage 2 requirements, but the ability to transmit to a third party was not found in the review.     

Patient and Provider Attitudes Toward the Use of Patient Portals for the Management of Chronic Disease: A Systematic Review

Background

Patient portals provide patients with the tools to better manage and understand their health status. However, widespread adoption of patient portals faces resistance from patients and providers for a number of reasons, and there is limited evidence evaluating the characteristics of patient portals that received positive remarks from patients and providers.

Objective

The objectives of this systematic review are to identify the shared characteristics of portals that receive favorable responses from patients and providers and to identify the elements that patients and providers believe need improvement.

Methods

The authors conducted a systematic search of the CINAHL and PubMed databases to gather data about the use of patient portals in the management of chronic disease. Two reviewers analyzed the articles collected in the search process in order remove irrelevant articles. The authors selected 27 articles to use in the literature review.

Results

Results of this systematic review conclude that patient portals show significant improvements in patient self-management of chronic disease and improve the quality of care provided by providers. The most prevalent positive attribute was patient-provider communication, which appeared in 10 of 27 articles (37%). This was noted by both patients and providers. The most prevalent negative perceptions are security (concerns) and user-friendliness, both of which occurred in 11 of 27 articles (41%). The user-friendliness quality was a concern for patients and providers who are not familiar with advanced technology and therefore find it difficult to navigate the patient portal. The high cost of installation and maintenance of a portal system, not surprisingly, deters some providers from implementing such technology into their practice, but this was only mentioned in 3 of the 27 articles (11%). It is possible that the incentives for meaningful use assuage the barrier of cost.

Conclusions

This systematic review revealed mixed attitudes from patients and their providers regarding the use of patient portals to manage their chronic disease. The authors suggest that a standard patient portal design providing patients with the resources to understand and manage their chronic conditions will promote the adoption of patient portals in health care organizations.     

Chronic disease detection and access: does access improve detection,or does detection make access more difficult?

Background

The recorded detection of chronic disease by practices is generally lower than the prevalence predicted by population surveys.

Aim

To determine whether patient-reported access to general practice predicts the recorded detection rates of chronic diseases in that setting.

Design and setting

A cross-sectional study involving 146 general practices in Leicestershire and Rutland, England.

Method

The numbers of patients recorded as having chronic disease (coronary heart disease, chronic obstructive pulmonary disease, hypertension, diabetes) were obtained from Quality and Outcomes Framework (QOF) practice disease registers for 2008–2009. Characteristics of practice populations (deprivation, age, sex, ethnicity, proportion reporting poor health, practice turnover, list size) and practice performance (achievement of QOF disease indicators, patient experience of being able to consult a doctor within 2 working days and book an appointment >2 days in advance) were included in regression models.

Results

Patient characteristics (deprivation, age, poor health) and practice characteristics (list size, turnover, QOF achievement) were associated with recorded detection of more than one of the chronic diseases. Practices in which patients were more likely to report being able to book appointments had reduced recording rates of chronic disease. Being able to consult a doctor within 2days was not associated with levels of recorded chronic disease.

Conclusion

Practices with high levels of deprivation and older patients have increased rates of recorded chronic disease. As the number of patients recorded with chronic disease increased, the capacity of practices to meet patients'' requests for appointments in advance declined. The capacity of some practices to detect and manage chronic disease may need improving.     

Quality of routine spirometry tests in Dutch general practices

Background

Spirometry is an indispensable tool for diagnosis and monitoring of chronic airways disease in primary care.

Aim

To establish the quality of routine spirometry tests in general practice, and explore associations between test quality and patient characteristics.

Design of study

Analysis of routine spirometry test records.

Setting

Fifteen general practices which had a working agreement with a local hospital pulmonary function laboratory for spirometry assessment regarding test quality and interpretation.

Method

Spirometry tests were judged by a pulmonary function technician and a chest physician. Proportions of test adequacy were analysed using markers for manoeuvre acceptability and test reproducibility derived from the 1994 American Thoracic Society spirometry guideline. Associations between quality markers and age, sex, and severity of obstruction were examined using logistic regression.

Results

Practices performed a mean of four (standard deviation = 2) spirometry tests per week; 1271 tests from 1091 adult patients were analysed; 96.4% (95% confidence interval [CI] = 95.6 to 97.2) of all tests consisted of ≥3 blows. With 60.6% of tests, forced expiratory time was the marker with the lowest acceptability rate. An overall 38.8% (95% CI = 36.0 to 41.6) of the tests met the acceptability as well as reproducibility criteria. Age, sex, and severity of obstruction were associated with test quality markers.

Conclusion

The quality of routine spirometry tests was better than in previous reports from primary care research settings, but there is still substantial room for improvement. Sufficient duration of forced expiratory time is the quality marker with the highest rate of inadequacy. Primary care professionals should be aware of patient characteristics that may diminish the quality of their spirometry tests. Further research is needed to establish to what extent spirometry tests that are inadequate, according to stringent international expert criteria, result in incorrect clinical interpretations in general practice.     

A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial

Background

Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers’ needs for information about the patient’s status or how the caregiver can help.

Objective

We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach.

Methods

We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a “CarePartner” outside their household. Patients randomized to “standard mHealth” (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients’ responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to “mHealth+CP” (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient’s status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments.

Results

Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, P<.01), and 10.2% more mHealth+CP patients reported talking with their CarePartner at least twice per week at the 6-month follow-up (P=.048). mHealth+CP patients were less likely to report negative emotions during those interactions at both endpoints (both P<.05), were consistently more likely to report taking medications as prescribed during weekly IVR assessments, and also were less likely to report breathing problems or weight gains (all P<.05). Among patients with more depressive symptoms at enrollment, those randomized to mHealth+CP were more likely than standard mHealth patients to report excellent or very good general health during weekly IVR calls.

Conclusions

Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal caregiver outside the household improved HF patients’ medication adherence and caregiver communication. mHealth+CP may also decrease patients’ risk of HF exacerbations related to shortness of breath and sudden weight gains. mHealth+CP may improve quality of life among patients with greater depressive symptoms. Weekly health and self-care monitoring via mHealth tools may identify intervention effects in mHealth trials that go undetected using typical, infrequent retrospective surveys.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00555360","term_id":"NCT00555360"}}NCT00555360; https://clinicaltrials.gov/ct2/show/{"type":"clinical-trial","attrs":{"text":"NCT00555360","term_id":"NCT00555360"}}NCT00555360 (Archived by WebCite at http://www.webcitation.org/6Z4Tsk78B).