Development of mWellcare: an mHealth intervention for integrated management of hypertension and diabetes in low-resource settings mHealth intervention to support asthma self-management in adolescents: the ADAPT study Effective behavioral intervention strategies using mobile health applications for chronic disease management: a systematic review Mobile Health Medication Adherence and Blood Pressure Control in Renal Transplant Recipients: A Proof-of-Concept Randomized Controlled Trial A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders Information system support as a critical success factor for chronic disease management: Necessary but not sufficient Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development Case management and self-management support for frequent users with chronic disease in primary care: a pragmatic randomized controlled trial Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial A Randomized Trial of Mobile Health Support for Heart Failure Patients and Their Informal Caregivers: Impacts on Caregiver-reported Outcomes Older adults’ readiness to engage with eHealth patient education and self-care resources: a cross-sectional survey Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India Improved delivery of cardiovascular care (IDOCC) through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care Evaluation of a nurse-led disease management programme for chronic kidney disease: a randomized controlled trial. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial Case Management for Depression by Health Care Assistants in Small Primary Care Practices Feasibility and Preliminary Outcomes of a Web and Smartphone–Based Medication Self-Management Platform for Chronically Ill Patients Implementation and effectiveness of 'care navigation', coordinated management for people with complex chronic illness: rationale and methods of a randomised controlled A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol Understanding potential uptake of a proposed mHealth program to support caregiver home management of childhood illness in a resource-poor setting: a qualitative evaluation.
ABSTRACT Background : Cardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India . Innovative approaches such as clinical decision support ( CDS ) software could play a major role in improving the quality of hypertension/diabetes care in primary care setting s. Objective : To describe the steps and processes in the development of mWellcare , a complex intervention based on mobile health ( mHealth ) technology . Methods : The Medical Research Council framework was used to develop mWellcare in four steps : ( 1 ) identify gaps in usual care through literature review and health facility assessment s ; ( 2 ) identify the components of the intervention through discussion s and consultations with experts ; ( 3 ) develop intervention ( clinical algorithms and mHealth system ) ; and ( 4 ) evaluate acceptability and feasibility through pilot testing in five community health centers . Results : Lack of evidence -based , integrated , and systematic management of chronic conditions were major gaps identified . Experts in information technology , clinical fields , and public health professionals identified intervention components to address these gaps . Thereafter , clinical algorithm context ualized to primary care setting s were prepared and the mWellcare intervention was developed . During the 2-month pilot , 631 patients diagnosed with hypertension and /or diabetes were registered , with a follow-up rate of 36.2 % . The major barrier was resistance to follow mWellcare recommended patient workflow , and to overcome it , we emphasized onsite training and orientation program to cover all health care team member in each CHC . Conclusion : A pilot-tested mWellcare intervention is an mHealth system with important components , i.e. integrated management of chronic conditions , evidence -based CDS , longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit , which will be used by nurses at primary health care setting s in India . The effectiveness and cost-effectiveness of the intervention will be tested through a cluster r and omized trial ( trial registration number NCT02480062 ) Purpose Poor medication adherence in adolescents with asthma results in poorly controlled disease and increased morbidity . The aim of the ADolescent Adherence Patient Tool ( ADAPT ) study is to develop an mHealth intervention to support self-management and to evaluate the effectiveness in improving medication adherence and asthma control . Intervention The ADAPT intervention consists of an interactive smartphone application ( app ) connected to a desktop application for health care providers , in this study , the community pharmacist . The app contains several functions to improve adherence as follows : 1 ) a question naire function to rate asthma symptoms and monitor these over time ; 2 ) short movie clips with medication and disease information ; 3 ) a medication reminder ; 4 ) a chat function with peers ; and 5 ) a chat function with the pharmacist . The pharmacist receives data from the patient ’s app through the desktop application , which enables the pharmacist to send information and feedback to the patient . Study design The ADAPT intervention is tested in a community pharmacy-based cluster r and omized controlled trial in the Netherl and s , aim ing to include 352 adolescents with asthma . The main outcome is adherence , measured by patient ’s self-report and refill adherence calculated from pharmacy dispensing records . In addition , asthma control , illness perceptions , medication beliefs , and asthma-related quality of life are measured . Conclusion This study will provide in-depth knowledge on the effectiveness of an mHealth intervention to support asthma self-management in adolescents . These insights will also be useful for adolescents with other chronic diseases Background Mobile health ( mHealth ) has continuously been used as a method in behavioral research to improve self-management in patients with chronic diseases . However , the evidence of its effectiveness in chronic disease management in the adult population is still lacking . We conducted a systematic review to examine the effectiveness of mHealth interventions on process measures as well as health outcomes in r and omized controlled trials ( RCTs ) to improve chronic disease management . Methods Relevant r and omized controlled studies that were published between January 2005 and March 2016 were search ed in six data bases : PubMed , CINAHL , EMBASE , the Cochrane Library , PsycINFO , and Web of Science . The inclusion criteria were RCTs that conducted an intervention using mobile devices such as smartphones or tablets for adult patients with chronic diseases to examine disease management or health promotion . Results Of the 12 RCTs review ed , 10 of the mHealth interventions demonstrated statistically significant improvement in some health outcomes . The most common features of mHealth systems used in the review ed RCTs were real-time or regular basis symptom assessment s , pre-programed reminders , or feedbacks tailored specifically to the data provided by participants via mHealth devices . Most studies developed their own mHealth systems including mobile apps . Training of mHealth systems was provided to participants in person or through paper-based instructions . None of the studies reported the relationship between health outcomes and patient engagement levels on the mHealth system . Conclusions Findings from mHealth intervention studies for chronic disease management have shown promising aspects , particularly in improving self-management and some health outcomes Background Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities ( eg , hypertension , diabetes ) . These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients ’ physiological data . This technology is also relatively inexpensive , has an intuitive interface , and provides the capability for real-time personalized feedback to help motivate patient self-efficacy . Automated summary reports of patients ’ adherence and blood pressure can easily be uploaded to providers ’ networks helping reduce clinical inertia by reducing regimen alteration time . Objective The aim of this study was to assess the feasibility , acceptability , and preliminary outcomes of a prototype mobile health ( mHealth ) medication and blood pressure ( BP ) self-management system for kidney transplant patients with uncontrolled hypertension . Methods A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design . The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback . A 3-month proof-of-concept r and omized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray . Participants r and omized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging . Controls received st and ard of care and their adherence continued to be monitored with the medication tray reminders turned off . Providers received weekly summary reports of patient medication adherence and BP readings . Results Participation and retention rates were 41/55 ( 75 % ) and 31/34 ( 91 % ) , respectively . The prototype system appears to be safe , highly acceptable , and useful to patients and providers . Compared to the st and ard care control group ( SC ) , the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations . Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the st and ard care group ( 7 adjustments in 5 patients versus 3 adjustments in 3 patients ) during the 3-month trial based on the information provided in the weekly reports . Conclusions These data support the acceptability and feasibility of the prototype mHealth system . Further trials with larger sample sizes and additional biomarkers ( eg , whole blood medication levels ) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control  after kidney transplantation over longer time periods . Trial Registration Clinical trials.gov NCT01859273 ; http:// clinical trials.gov/ct2/show/NCT01859273 ( Archived by WebCite at http://www.webcitation.org/6IqfCa3A3 ) Background Nonadherence to prescribed medication regimens is a substantial barrier to the pharmacological management of alcohol use disorders . The availability of low-cost , sustainable interventions that maximize medication adherence would likely lead to improved treatment outcomes . Mobile health ( mHealth ) technologies are increasingly being adopted as a method of delivering behavioral health interventions and represent a promising tool for adherence interventions . We are evaluating a cell-phone – based intervention called AGATE that seeks to enhance adherence with regular text-messaging . Methods / Design A r and omized controlled effectiveness trial in the context of an eight-week open label naltrexone efficacy trial delivered in a naturalistic clinical setting . Treatment-seeking heavy drinkers ( N = 105 ) are currently being recruited and r and omly assigned to the AGATE intervention or a control condition .  Daily measures of alcohol use and medication side effects are being recorded via cell phone in both conditions . Additionally , participants r and omized to the AGATE condition receive medication reminders via SMS text message according to a schedule that adjusts according to their level of adherence . Discussion Results from this trial will provide initial information about the feasibility and efficacy of mHealth interventions for improving adherence to alcohol pharmacotherapies . Trial Registration NCT01349985 UNLABELLED Improvement of chronic disease management in primary care entails monitoring indicators of quality over time and across patients and practice s. Informatics tools are needed , yet implementing them remains challenging . OBJECTIVE To identify critical success factors enabling the translation of clinical and operational knowledge about effective and efficient chronic care management into primary care practice . DESIGN A prospect i ve case study of positive deviants using key informant interviews , process observation , and document review . SETTING A chronic disease management ( CDM ) collaborative of primary care physicians with documented improvement in adherence to clinical practice guidelines using a web-based patient registry system with CDM guideline -based flow sheet . PARTICIPANTS Thirty community-based physician participants using predominantly paper records , plus a project management team including the physician lead , project manager , evaluator and support team . ANALYSIS A critical success factor ( CSF ) analysis of necessary and sufficient pathways to the translation of knowledge into clinical practice . RESULTS A web-based CDM ' toolkit ' was found to be a direct CSF that allowed this group of physicians to improve their practice by tracking patient care processes using evidence -based clinical practice guideline -based flow sheets . Moreover , the information and communication technology ' factor ' was sufficient for success only as part of a set of seven direct CSF components including : health delivery system enhancements , organizational partnerships , funding mechanisms , project management , practice models , and formal knowledge translation practice s. Indirect factors that orchestrated success through the direct factor components were also identified . A central insight of this analysis is that a comprehensive quality improvement model was the CSF that drew this set of factors into a functional framework for successful knowledge translation . CONCLUSIONS In complex primary care setting s environment where physicians have low adoption rates of electronic tools to support the care of patients with chronic conditions , successful implementation may require a set of interrelated system and technology factors Background Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients . Pharmacists are suited to impact medication adherence given their training , skills , and frequent contact with patients . The Empowering pharmacists in asthma management through interactive SMS ( EmPhAsIS ) trial involves an intervention leveraging mobile health ( mHealth ) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma . Methods / Design This study is a pragmatic pharmacy-based , cluster , r and omized controlled trial with 12 months of intervention delivery and follow-up . Pharmacies ( the clusters ) will be r and omized at a 1:1 ratio to provide intervention or usual care . The EmPhAsIS intervention consists of patient asthma education , short message service (SMS)-based monthly assessment of adherence , and follow-up of non-adherent individuals by community pharmacists . There are no inclusion or exclusion criteria for pharmacies . Patients are eligible if they : are 14 years of age or older , fill a prescription for inhaled corticosteroid ( either monotherapy or in a combination inhaler with long-acting beta-agonists ) , have been diagnosed with asthma , possess a mobile phone with SMS capabilities , and have no communication difficulties such as inability to communicate in English , or significant impairment in vision , hearing , or speech . The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio , the ratio of the days of medication supplied to days in a given time interval . This study will also evaluate secondary outcomes including : asthma control , asthma-related quality of life , asthma-related hospital admissions , and use of reliever medications during the follow-up period . A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon . Discussion Considering the prevalence of asthma , the extent of the non-adherence problem in this disease , and the availability of effective treatments , there is a tremendous potential to reduce the burden of asthma through improving adherence . This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management . Trial registration Clinical Trials.gov identifier : NCT02170883 ; date of registration : 19 June 2014 Background Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer . While oral chemotherapy includes benefits such as ease of administration , convenience , and minimization of invasive infusions , patients receive less oversight , support , and symptom monitoring from clinicians . Additionally , adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens . With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology , we created a mobile health intervention for medication and symptom management . Objective The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app  to support adherence to oral chemotherapy and symptom management in patients with cancer . Methods We used a 5-step development model to create a comprehensive mobile app with theoretically informed content . The research and technical development team worked together to develop and iteratively test the app . In addition to the research team , key stakeholders including patients and family members , oncology clinicians , health care representatives , and practice administrators contributed to the content refinement of the intervention . Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the r and omized controlled trial . Results We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing . App components included  medication reminders , self-reporting of medication adherence and symptoms , an education library including nutritional information , Fitbit integration , social networking re sources , and individually tailored symptom management feedback .  We are conducting a r and omized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy , quality of life , and burden of symptoms and side effects . At every stage in this trial , we are engaging stakeholders to solicit feedback on our progress and next steps . Conclusions To our knowledge , we are the first to describe the development of an app design ed for people taking oral chemotherapy . The app addresses many concerns with oral chemotherapy , such as medication adherence and symptom management . Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients , caregivers , and clinicians . In our development process , we instantiated 7 of the 8 best practice s proposed in a recent review of mobile health app development . Our process demonstrated the importance of effective communication between research groups and technical teams , as well as meticulous planning of technical specifications before development begins . Future efforts should consider incorporating other proven strategies in software , such as gamification , to bolster the impact of mobile health apps . Forthcoming results from our r and omized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management . Trial Registration Clinical Trials.gov NCT02157519 ; https:// clinical trials.gov/ct2/show/NCT02157519 ( Archived by WebCite at http://www.webcitation.org/6prj3xfKA Background Chronic diseases represent a major challenge for health care and social services . A number of people with chronic diseases require more services due to characteristics that increase their vulnerability . Given the burden of increasingly vulnerable patients on primary care , a pragmatic intervention in four Family Medicine Groups ( primary care practice s in Quebec , Canada ) has been proposed for individuals with chronic diseases ( diabetes , cardiovascular diseases , respiratory diseases , musculoskeletal diseases and /or chronic pain ) who are frequent users of hospital services . The intervention combines case management by a nurse with group support meetings encouraging self-management based on the Stanford Chronic Disease Self-Management Program . The goals of this study are to : ( 1 ) analyze the implementation of the intervention in the participating practice s in order to determine how the various context s have influenced the implementation and the observed effects ; ( 2 ) evaluate the proximal ( self-efficacy , self-management , health habits , activation and psychological distress ) and intermediate ( empowerment , quality of life and health care use ) effects of the intervention on patients ; ( 3 ) conduct an economic analysis of the efficiency and cost-effectiveness of the intervention . Methods / Design The analysis of the implementation will be conducted using realistic evaluation and participatory approaches within four categories of stakeholders ( Family Medicine Group and health centre management , Family Medicine Group practitioners , patients and their families , health centre or community partners ) . The data will be obtained through individual and group interviews , project documentation review s and by documenting the intervention . Evaluation of the effects on patients will be based on a pragmatic r and omized before-after experimental design with a delayed intervention control group ( six months ) . Economic analysis will include cost-effectiveness and cost-benefit analysis . Discussion The integration of a case management intervention delivered by nurses and self-management group support into primary care practice s has the potential to positively impact patient empowerment and quality of life and hopefully reduce the burden on health care . Decision-makers , managers and health care professionals will be aware of the factors to consider in promoting the implementation of this intervention into other primary care practice s in the region and elsewhere . Trial Registration Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry : Introduction Multimorbidity increases care needs and primary care use among people with chronic diseases .  The Concerto Health Program ( CHP ) has been developed to optimise chronic disease management in primary care services . However , in its current version , the CHP primarily targets clinicians and does not aim to answer directly patients ’ and their informal caregivers ’ needs for chronic disease management . Various studies have shown that interventions that increase patient activation level are associated with better health outcomes . Furthermore , educational tools must be adapted to patients and caregivers in terms of health literacy and usability . This project aims to develop , implement and evaluate a user-centred , multifunctional and personalised eHealth platform ( CONCERTO+ ) to promote a more active patient role in chronic disease management and decision-making . Methods and analysis This project uses a collaborative research approach , aim ing at the personalisation of CHP through three phases : ( 1 ) the development of one module of an eHealth platform based on scientific evidence and user-centred design ; ( 2 ) a feasibility study of CONCERTO+ through a pilot cluster r and omised controlled trial where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ during 6 months and be compared to patients from a control practice receiving usual care and ( 3 ) an analysis of CONCERTO+ potential for scaling up . To do so , we will conduct two focus groups with patients and informal caregivers and individual interviews with health professionals at the two study sites , as well as health care managers , information officers and representatives of the Ministry of Health . Ethics and dissemination This study received ethical approval from Ethics Committee of Université Laval . The findings will be used to inform the effectiveness of CONCERTO+  to improve management care in chronic diseases . We will disseminate findings through presentations in scientific conferences and publication in peer- review ed journals . Trial registration number NCT03628963 ; Pre- results Background : Mobile health services may improve chronic illness care , but interventions rarely support informal caregivers ’ efforts . Objectives : To determine whether automated feedback to caregivers of chronic heart failure patients impacts caregiving burden and assistance with self-management . Research Design : R and omized comparative effectiveness trial . Subjects : A total of 369 heart failure patients were recruited from a Veterans Health Administration health care system . All patients participated with a “ CarePartner ” or informal caregiver outside their household . Intervention : Patients r and omized to “ st and ard mHealth ”  received weekly automated self-care support calls for 12 months with notifications about problems sent to clinicians . “ mobile health+CarePartner ” ( mHealth+CP ) patients received identical services , plus email summaries and suggestions for self-care assistance automatically sent to their CarePartners . Measures : At baseline , 6 , and 12 months , CarePartners completed assessment s of caregiving strain , depressive symptoms , and participation in self-care support . Results : mHealth+CP CarePartners reported less caregiving strain than controls at both 6 and 12 months ( both P⩽0.03 ) . That effect as well as improvements in depressive symptoms were seen primarily among CarePartners reporting greater burden at baseline ( P⩽0.03 for interactions between arm and baseline strain/depression at both endpoints ) . Although most mHealth+CP CarePartners increased the amount of time spent in self-care support , those with the highest time commitment at baseline reported decreases at both follow-ups ( all P<0.05 ) . mHealth+CP CarePartners reported more frequently attending patients ’ medical visits at 6 months ( P=0.049 ) and greater involvement in medication adherence at both endpoints ( both P⩽0.032 ) . Conclusions : When CarePartners experienced significant caregiving strain and depression , systematic feedback about their patient-partner decreased those symptoms . Feedback also increased most CarePartners ’ engagement in self-care Background This study examined access to digital technologies , skills and experience , and preferences for using web-based and other digital technologies  to obtain health information and advice among older adults in a large health plan . A primary aim was to assess the extent to which digital divides by race/ethnicity and age group might affect the ability of a large percentage of seniors , and especially those in vulnerable groups , to engage with online health information and advice modalities ( eHIA ) and mobile health ( mHealth ) monitoring tools . Methods A mailed survey was conducted with age-sex stratified r and om sample s of English-speaking non-Hispanic white , African-American/black ( black ) , Hispanic/Latino ( Latino ) , Filipino-American ( Filipino ) , and Chinese-American ( Chinese ) Kaiser Permanente Northern California members who were aged 65–79 years . Respondent data were weighted to the study population for the cross-sectional analyses . Results Older seniors and black , Latino , and Filipino seniors have less access to digital tools , less experience performing a variety of online tasks , and are less likely to believe that they would be capable of going online for health information and advice compared to younger and white Non-Hispanic seniors . Consequently , they are also less likely to be interested in using eHIA modalities . Conclusions The same subgroups of seniors that have previously been shown to have higher prevalence of chronic conditions and greater difficulties with healthcare access are also less likely to adopt use of eHIA and  mHealth monitoring technologies . At the patient population level , this digital divide is important to take into account when planning health information and chronic disease management programs . At the individual patient level , to provide good patient-centered care , it is important for providers to assess rather than assume digital access , eHealth skills , and preferences prior to recommending use of web-based re sources and mHealth tools Introduction Rising burden of cardiovascular disease ( CVD ) and diabetes is a major challenge to the health system in India . Innovative approaches such as mobile phone technology ( mHealth ) for electronic decision support in delivering evidence -based and integrated care for hypertension , diabetes and comorbid depression have potential to transform the primary healthcare system . Methods and analysis mWellcare trial is a multicentre , cluster r and omised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India .  mWellcare system is an And roid-based mobile application design ed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records , sending alerts and reminders for follow-up and adherence to medication . We recruited a total of 3702 participants from 40 Community Health Centres ( CHCs ) , with ≥90 at each of the CHCs in the intervention and control ( enhanced care ) arms . The primary outcome is the difference in mean change ( from baseline to 1 year ) in systolic blood pressure and glycated haemoglobin ( HbA1c ) between the two treatment arms . The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose , total cholesterol , predicted 10-year risk of CVD , depression , smoking behaviour , body mass index and alcohol use between the two treatment arms and cost-effectiveness . Ethics and dissemination The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine . Findings will be disseminated widely through peer- review ed publications , conference presentations and other mechanisms . Trial registration mWellcare trial is registered with Clinical trial.gov ( Registration number NCT02480062 ; Pre- results ) and Clinical Trial Registry of India ( Registration number CTRI/2016/02/006641 ) . The current version of the protocol is Version 2 date d 19 October 2015 and the study sponsor is Public Health Foundation of India , Gurgaon , India ( www.phfi.org ) Background There is a need to find innovative approaches for translating best practice s for chronic disease care into daily primary care practice routines . Primary care plays a crucial role in the prevention and management of cardiovascular disease . There is , however , a substantive care gap , and many challenges exist in implementing evidence -based care . The Improved Delivery of Cardiovascular Care ( IDOCC ) project is a pragmatic trial design ed to improve the delivery of evidence -based care for the prevention and management of cardiovascular disease in primary care practice s using practice outreach facilitation . Methods The IDOCC project is a stepped-wedge cluster r and omized control trial in which Practice Outreach Facilitators work with primary care practice s to improve cardiovascular disease prevention and management for patients at highest risk . Primary care practice s in a large health region in Eastern Ontario , Canada , were eligible to participate . The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period . Starting with audit and feedback , consensus building , and goal setting , the practice s are supported in changing practice behavior by incorporating chronic care model elements . These elements include ( a ) evidence -based decision support for providers , ( b ) delivery system re design for practice s , ( c ) enhanced self-management support tools provided to practice s to help them engage patients , and ( d ) increased community re source linkages for practice s to enhance referral of patients . The primary outcome is a composite score measured at the level of the patient to represent each practice 's adherence to evidence -based guidelines for cardiovascular care . Qualitative analysis of the Practice Outreach Facilitators ' written narratives of their ongoing practice interactions will be done . These textual analyses will add further insight into underst and ing critical factors impacting project implementation . Discussion This pragmatic , stepped-wedge r and omized controlled trial with both quantitative and process evaluations demonstrates innovative methods of implementing large-scale quality improvement and evidence -based approaches to care delivery . This is the first Canadian study to examine the impact of a large-scale multifaceted cardiovascular quality -improvement program in primary care . It is anticipated that through the evaluation of IDOCC , we will demonstrate an effective , practical , and sustainable means of improving the cardiovascular health of patients across Canada . Trial Registration Clinical Trials.gov : BACKGROUND Patients with end stage renal failure require dialysis and strict adherence to treatment plans to sustain life . However , non-adherence is a common and serious problem among patients with chronic kidney disease . There is a scarcity of studies in examining the effects of disease management programmes on patients with chronic kidney disease . OBJECTIVES This paper examines whether the study group receiving the disease management programme  have better improvement than the control group , comparing outcomes at baseline ( O1 ) , at 7 weeks at the completion of the programme ( O2 ) and at 13 weeks ( O3 ) . METHODS This is a r and omized controlled trial . The outcome measures were non-adherence in diet , fluid , dialysis and medication , quality of life , satisfaction , symptom control , complication control and health service utilisation . RESULTS There was no significant difference between the control and study group for the baseline measures , except for sleep . Significant differences ( p<0.05 ) were found between the control and study group at O2 in the outcome measures of diet degree non-adherence , sleep , symptom , staff encouragement , overall health and satisfaction . Sustained effects at O3 were noted in the outcome measures of continuous ambulatory peritoneal dialysis ( CAPD ) non-adherence degree , sleep , symptom , and effect of kidney disease . CONCLUSIONS Many studies exploring chronic disease management have neglected the group with end stage renal failure and this study fills this gap . This study has employed an innovative model of skill mix using specialist and general nurses and demonstrated patient improvement in diet non-adherence , CAPD non-adherence , aspects of quality of life and satisfaction with care . Re design ing chronic disease management programmes helps to optimize the use of different levels of skills and re sources to bring about positive outcomes Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency . After a r and omized controlled trial of a multilingual automated telephone self-management support program ( ATSM ) improved patient-centered dimensions of diabetes care in safety net clinics , we collaborated with a nonprofit Medicaid managed care plan to translate research into practice , offering ATSM as a covered benefit and augmenting ATSM to promote medication activation . This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project ( SMARTSteps ) . Methods / Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English , Cantonese , or Spanish and receive care at 4 publicly-funded clinics . Through language -stratified r and omization , participants were assigned to four intervention statuses : SMARTSteps-ONLY , SMARTSteps-PLUS , or wait-list for either intervention . In addition to usual primary care , intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care , medication adherence , safety concerns , psychological issues , and preventive services . Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning . SMARTSteps-PLUS also included health coach calls to promote medication activation , adherence and intensification , if triggered by ATSM-reported non-adherence , refill non-adherence from pharmacy cl aims , or suboptimal cardiometabolic indicators . Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months . For participants who agreed to structured telephone interviews at baseline and 6 months ( n = 252 ) , primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care . We will also evaluate 6-month changes in cardiometabolic ( HbA1c , blood pressure , and LDL ) and utilization indicators for all participants . Discussion Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net setting s. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable population s with chronic disease . Trial Registration Clinical Trials.gov : Background The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems . This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies . Methods In this multicenter open-label trial , 1,360 patients recruited after hospitalization for heart failure exacerbation ( 38 % ) or from the community ( 62 % ) were r and omly assigned to either disease management or usual care . Disease management , delivered by multi-disciplinary teams , included coordination of care , patient education , monitoring disease symptoms and patient adherence to medication regimen , titration of drug therapy , and home tele-monitoring of body weight , blood pressure and heart rate . Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists . The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause . Secondary endpoints included the number of all hospital admissions , health-related quality of life and depression during follow-up . Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center . Results During the follow-up , 388 ( 56.9 % ) patients assigned to disease management and 387 ( 57.1 % ) assigned to usual care had a primary endpoint event . The median ( range ) time elapsed until the primary endpoint event or end of study was 2.0 ( 0–5.0 ) years among patients assigned to disease management , and 1.8 ( 0–5.0 ) years among patients assigned to usual care ( adjusted hazard ratio , 0.908 ; 95 % confidence interval , 0.788 to 1.047 ) . Hospital admissions were mostly ( 70 % ) unrelated to heart failure . Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up . Conclusions This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint , but it improved health-related quality of life and depression . A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care . Clinical trial registration Clinical trials.gov identifier : NCT00533013 . Trial registration date : 9 August 2007 . Initial protocol release date : 20 September 2007 Context Few studies have evaluated whether health care assistants can improve care for depressed patients .  Contribution Patients who were r and omly assigned to receive telephone case management by health care assistants  reported slightly greater improvements in depression symptoms , better adherence to antidepressant therapies , and more favorable assessment s of the quality of their care than did patients r and omly assigned to receive usual care .  Implication Telephone case management facilitated by health care assistants may be a feasible mechanism for small primary care practice s to improve care of their patients with depression . The Editors Depression causes a substantial disease burden ( 1 ) and is responsible for annual health care costs of about $ 83.1 billion in the United States ( 2 , 3 ) . Most patients with depression are treated in primary care ( 46 ) . Collaborative care can improve depression outcomes by providing decision support and clinical information for family physicians , as well as self-management support and follow-up for patients . However , evidence regarding collaborative depression care stems mostly from academic or managed care setting s in the United States ( 711 ) . In these trials , family physicians generally relied on mental health case managers and decision support from mental health specialists ( 12 ) . Case management is a patient-centered element of collaborative care that may be effective in primary care ( 13 ) . It comprises systematic tracking of patients , support for continuing the treatment , and taking action in the case of nonadherence or lack of improvement ( 14 ) . Collaborative depression care has generally yielded positive results in diverse primary care setting s ( 7 ) . The IMPACT ( Improving MoodPromoting Access to Collaborative Treatment ) trial found that care managers who were supervised by psychiatrists and who provided education and support for medication adherence reduced depression symptoms in older patients ( 15 ) . Dietrich and colleagues ( 16 ) found that telephone support , provided by a trained , central ly based mental health care manager who was supervised by a psychiatrist , improved depression symptoms . Dobscha and colleagues ( 17 ) evaluated a primary care decision-support team for depression ( comprising a psychiatrist and a mental health nurse ) and found improved care processes but no differences in depression symptoms ( 17 ) , possibly because of less intensive follow-up of patients . Small , isolated primary care setting s often have limited re sources ( 18 ) . In the United States , 26 % of primary care practice s are solo practice s or 2-person partnerships , in which extensive collaborative models would be difficult to implement , and 22 % are located in rural areas with limited access to mental health specialists ( 19 ) . Health care assistants are established professionals in primary care setting s. They have less training than U.S. physician assistants or nurse practitioners , who provide first-contact care , and need not be college graduates ( 20 ) . In Germany , health care assistants have 3 years of on-the-job training . They are mainly responsible for administrative tasks in general practice but provide basic clinical procedures ( 21 ) . Health care assistants are a potentially important re source for enhancing patient care in primary care setting s ( 20 ) . Our aim was to evaluate whether case management by a practice -based health care assistant can reduce depression symptoms and improve the process of care for patients with major depression in small primary care practice s. Methods We design ed a pragmatic , cluster r and omized , controlled trial that used practice as the unit of r and omization to avoid contamination ( 22 ) . The institutional review board of Goethe University Frankfurt am Main , Frankfurt am Main , Germany , approved the study protocol on 25 April 2005 ( 23 ) . We used written consent procedures for family physicians and patients . We recruited practice s between February 2005 and May 2005 and patients between May 2005 and July 2006 . We carried out the intervention between June 2005 and August 2007 . We completed the last follow-up for study patients in September 2007 . Setting and Participants After calculating the sample size ( 24 ) , we informed all 1600 family physicians registered with the medical association of the state of Hesse , Germany ( m and atory registration ) , about the trial and invited them by mail to participate in information meetings . As the registration list presents only names and addresses , we checked inclusion criteria only for those who participated in the meetings . We stopped recruiting when 74 practice s had enrolled , even though more practice s were interested in participating . Inclusion criteria for the practice s were acceptance of all major health plans ( 90 % of patients are covered by this type of insurance ) ( 25 ) ; provision of a primary care service , according to the definition of Starfield and colleagues ( 26 ) ; and management by a family physician . Patients were screened on special date s and referred to the trial by the family physician in the primary care practice . Inclusion criteria for patients were diagnosis of major depression with indication for any antidepressive treatment , age 18 to 80 years , access to a private telephone , ability to give informed consent , and ability to communicate in German . The diagnosis of major depression was based on a score of more than 9 points and a categorical diagnosis in the Patient Health Question naire-9 ( PHQ-9 ) ( 27 ) , and was confirmed by the family physician by using the checklists in the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , and International Classification of Diseases , Tenth Edition . New patients were double-screened with the same procedure within 2 weeks . Exclusion criteria were confirmed pregnancy , severe alcohol or illicit drug consumption , or acute suicidal ideation assessed by the family physician . R and omization and Interventions The data safety and monitoring board stratified the practice s according to the size of the city and performed computer-based r and omization . Patient r and om assignment status was nested within the practice status . The data safety and monitoring board was responsible for allocation concealment by keeping the r and omization results in a secure data base . Because of the practice staff training required for the behavioral intervention , patients , health care assistants , family physicians , and research ers were not blinded to assignment once the trial was started . We design ed our case management intervention in accordance with the Chronic Care Model ( 28 , 29 ) , which emphasizes proactive support for the patient by the entire practice team . We trained 1 health care assistant from each practice assigned to the intervention group in 2 workshops ( an 11-hour and a 6-hour workshop ) . This interactive training included information on depression , communication skills , telephone monitoring , and behavioral activation for the patient ( 3032 ) . The health care assistants contacted their patients by telephone twice a week in the first month and than once a month for the following 11 months . They monitored depression symptoms and adherence to medication by using the Depression Monitoring List ( 33 ) . Health care assistants also encouraged patients to follow self-management activities , such as medication adherence and activation for pleasant or social activities . The assistants provided this information to the family physician in a structured report that stratified the urgency of the contact by a robot scheme . Family physicians in both the intervention and control groups received training on evidence -based depression treatment guidelines ( 34 ) . During the trial , other forms of disease or case management programs were uncommon in Germany ( 35 ) . No study practice carried out case management for any other diseases . Outcomes and Follow-up Self-rating question naires were h and ed out to the patients at baseline and at 6 and 12 months after baseline . Patients filled in the question naires at home and sent them back to the practice . We collected the question naires in the practice s and collected data from patient records ( number of family physician and specialist contacts , hospitalization , and prescribed medication ) . Research staff carried out data input and management ( 36 ) . Serious adverse events were reported to the data safety and monitoring board . Clinical Outcomes The primary outcome was depression symptoms , which we assessed by using the primary carevali date d PHQ-9 ( 37 ) . Each item is scored from 0 ( not at all ) to 3 ( nearly every day ) , for a total score that ranges from 0 to 27 ( high scores indicate more severe depression ) . We assessed response ( 50 % improvement in PHQ-9 score ) and remission status ( PHQ-9 score<5 ) as secondary outcomes . We also report data for the following secondary outcomes : quality of life , patient assessment of chronic illness care , and medication adherence . We measured health-related quality of life by using the  Medical Outcomes Study Short Form 36 ( SF-36 ) ( 38 , 39 ) and the  EuroQol-5D  ( 40 ) . The SF-36 allows the calculation of scores for physical health and mental health ( range , 0 to 100 ; higher scores indicate better status ) . The EuroQol-5D is a generic instrument that measures health-related quality of life with a visual analogue scale ( range , 0 to 100 ; higher ratings indicate higher quality of life ) . We determined the number of physical comorbid conditions by counting the documented diagnoses from different diagnostic groups listed in the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , and International Classification of Diseases , Tenth Edition , excluding all psychiatric diagnoses in the patient record . We assessed severity of chronic physical diseases by using the Chronic Disease Score , on the basis of prescription data from the patient record ( 41 ) . Process-of-Care Outcomes We assessed the number of family physician and mental health specialist contacts , as well as prescriptions for Objective The aim of this study was to assess the feasibility and preliminary outcomes of a medication self-management platform for chronically ill patients , Medplan . Methods We performed a 6-month single-arm prospect i ve pre-post intervention study of patients receiving treatment for hypertension and /or dyslipidemia and /or heart failure and /or human immunodeficiency virus infection . During the pre-intervention phase , participants were followed according to their usual care ; during the intervention phase , they used Medplan . We evaluated adherence , health outcomes , healthcare re sources and measured the satisfaction of patients and health care professionals . Results The study population comprised 42 patients . No differences were found in adherence to medication measured by proportion of days covered with medication ( PDC ) . However , when adherence was measured using the SMAQ , the percentage of adherent patients improved during the intervention phase ( p < 0.05 ) , and the number of days with missed doses decreased ( p < 0.05 ) . Adherence measured using the Medplan app showed poor concordance with PDC . No differences were found in health outcomes or in the use of health care re sources during the study period . The mean satisfaction score for Medplan was 7.2 ± 2.7 out of 10 among patients and 7.3 ± 1.7 among health care professionals . In fact , 71.4 % of participants said they would recommend the app to a friend , and 88.1 % wanted to continue using it . Conclusion The Medplan platform proved to be feasible and was well accepted by its users . However , its impact on adherence differed depending on the assessment method . The lack of effect on PDC is mainly because patients were already good adherers at baseline . The study enabled us to vali date the platform in real patients using many different mobile devices and to identify potential barriers to scaling up the platform Background Chronic illness is a significant driver of the global burden of disease and associated health care costs . People living with severe chronic illness are heavy users of acute hospital services ; better coordination of their care could potentially improve health outcomes while reducing hospital use . The Care Navigation trial will evaluate an in-hospital coordinated care intervention on health service use and quality of life in chronically ill patients . Methods / Design A r and omised controlled trial in 500 chronically ill patients presenting to the emergency department of a hospital in Western Sydney , Australia . Participants have three or more hospital admissions within a previous 12 month period and either aged ≥70 years ; or aged ≥45 years and of Aboriginal or Torres Strait Isl and er descent ; or aged ≥ 16 with a diagnosis of a respiratory or cardiology related illness . Patients are r and omised to either the coordinated care program ( Care Navigation ) , or to usual care . The Care Navigation program consists of dedicated nurses who conduct patient risk assessment s , oversee patient nursing while in hospital , and guide development of a care plan for the management of chronic illness after being discharged from hospital . These nurses also book community appointments and liaise with general practitioners . The main outcome variables are the number of emergency department re-presentations and hospital readmissions , and quality of life during a 24 month follow-up . Secondary outcomes are length of hospital stay , mortality , time to first hospital re-admission , time to first emergency department re-presentation , patient satisfaction , adherence to prescribed medications , amount and type of in-hospital referrals made for consultations and diagnostic testing , and the number and type of community health referrals . A process evaluation and economic analysis will be conducted alongside the r and omised trial . Discussion A trial of in-hospital care coordination may support recent evidence that engaging primary health services in care plans linked to multidisciplinary team support improves patient outcomes and reduces costs to the health system . This will inform local , national and international health policy . Trial registration Australia New Zeal and Clinical Trials Registry Background Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia , affecting an estimated 2.7 million Americans . The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic ; therefore , it is challenging to detect and record an occurrence in a “ real world ” setting . To date , mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated . This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality -adjusted life years . Furthermore , sending a daily electrocardiogram transmission , coupled with receiving educational and motivational text messages aim ed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions ( e.g. , hypertension , diabetes , heart failure , etc . ) . Therefore , we are currently conducting a r and omized controlled trial to assess the efficacy of a mobile health intervention , iPhone ® Helping Evaluate Atrial fibrillation Rhythm through Technology ( iHEART ) versus usual cardiac care . Methods The iHEART study is a single center , prospect i ve , r and omized controlled trial . A total of 300 participants with a recent history of atrial fibrillation will be enrolled . Participants will be r and omized 1:1 to receive the iHEART intervention , receiving an iPhone ® equipped with an AliveCor ® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months . Discussion This will be the first study to investigate the utility of a mobile health intervention in a “ real world ” setting . We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention 's impact on improving clinical outcomes , quality of life , quality -adjusted life-years and disease-specific knowledge . Trial registration NCT02731326 ; Verified April BACKGROUND Extensive uptake of mobile phones offers an unprecedented opportunity to improve global healthcare delivery , especially among underserved population s.  Mobile health ( mHealth ) has been increasingly recognized as a promising approach to addressing challenges in global maternal-child health and may play an important role in accelerating progress towards improved outcomes . However , more evidence guiding development of mHealth interventions is needed . The current study explores factors that may support or hinder adoption and use of a proposed mHealth intervention to improve caregiver home management of common childhood illnesses in order to shape program development . METHODS Elicitation interviews were conducted with a convenience sample of 25 mothers recruited from a larger cluster-r and omized survey sample in the Cono Norte region of Arequipa , Peru . Interview data were analyzed in Spanish to preserve important cultural nuances . RESULTS Thematic analysis revealed potential facilitators of and barriers to uptake of the proposed mHealth program . Potential facilitators of caregiver participation include opportunity to engage in two-way communication with healthcare providers , development of instrumental and support knowledge to care for sick children , and healthcare challenges faced in a re source -poor community . Potential barriers include preference for in-person healthcare visits , program cost , text messaging abilities , and concern around program legitimacy . CONCLUSIONS This study underscores the potential for mHealth to improve global healthcare delivery in the area of maternal-child health . It demonstrates that mHealth interventions can meet the needs of vulnerable population s by offering novel approaches to promoting evidence -based care . This in-depth underst and ing of factors that may influence participation and use of this proposed mHealth program will help shape development of the intervention in this community
There is potential for mHealth tools to better facilitate adherence to chronic disease management , but the evidence supporting its current effectiveness is mixed .
BACKGROUND Adherence to chronic disease management is critical to achieving improved health outcomes , quality of life , and cost-effective health care .
As the burden of chronic diseases continues to grow globally , so does the impact of non-adherence .
Mobile technologies are increasingly being used in health care and public health practice ( mHealth ) for patient communication , monitoring , and education , and to facilitate adherence to chronic diseases management .
OBJECTIVE We conducted a systematic review of the literature to evaluate the effectiveness of mHealth in supporting the adherence of patients to chronic diseases management ( " mAdherence " ) , and the usability , feasibility , and acceptability of mAdherence tools and platforms in chronic disease management among patients and health care providers .