Telemonitoring Intervention Research Articles

A telemonitoring intervention design for patients with poorly controlled type 2 diabetes: protocol for a feasibility study.

Maintaining optimal glycemic control in type 2 diabetes (T2D) is difficult. Telemedicine has the potential to support people with poorly regulated T2D in the achievement of glycemic control, especially if the telemedicine solution includes a telemonitoring component. However, the ideal telemonitoring design for people with T2D remains unclear. Therefore, the aim of this feasibility study is to evaluate the feasibility of two telemonitoring designs for people with non-insulin-dependent T2D with a goal of identifying the optimal telemonitoring intervention for a planned future large-scale randomized controlled trial. This 3-month randomized feasibility study will be conducted in four municipalities in North Denmark starting in January 2024. There will be 15 participants from each municipality. Two different telemonitoring intervention designs will be tested. One intervention will include self-monitoring of blood glucose (SMBG) combined with sleep and mental health monitoring. The second intervention will include an identical setup but with the addition of blood pressure and activity monitoring. Two municipalities will be allocated to one intervention design, whereas the other two municipalities will be allocated to the second intervention design. Qualitative interviews with participants and clinicians will be conducted to gain insight into their experiences with and acceptance of the intervention designs and trial procedures (e.g., blood sampling and questionnaires). In addition, sources of differences in direct intervention costs between the two alternative interventions will be investigated. Telemonitoring has the potential to support people with diabetes in achieving glycemic control, but the existing evidence is inconsistent, and thus, the optimal design of interventions remains unclear. The results of this feasibility study are expected to produce relevant information about telemonitoring designs for people with T2D and help guide the design of future studies. A well-tested telemonitoring design is essential to ensure the quality of telemedicine initiatives, with goals of user acceptance and improved patient outcomes. ClinicalTrials.gov, ID: NCT06134934 . Registered November 1, 2023. The feasibility trial has been approved (N-20230026) by the North Denmark Region Committee on Health Research Ethics (June 5, 2023).

0537 Enhancing PAP Adherence in Black and Hispanic Patients Utilizing an Automated Telemonitoring Intervention

0537 Enhancing PAP Adherence in Black and Hispanic Patients Utilizing an Automated Telemonitoring Intervention

Bottom-Up Analysis of Telemonitoring Costs: A Case Study in Slovenian Primary Care.

Telemonitoring improves clinical outcomes in patients with arterial hypertension (AH) and type 2 diabetes (T2D), however, cost structure analyses are lacking. This study seeks to explore the cost structure of telemonitoring for the elderly with AH and T2D in primary care and identify factors influencing costs for potential future expansions. Infrastructure, operational, patient participation, and out-of-pocket costs were determined using a bottom-up approach. Infrastructure costs were determined by dividing equipment and telemonitoring platform expenses by the number of participants. Operational and patient participation costs were determined by considering patient training time, data measurement/review time, and teleconsultation time. The change in out-of-pocket costs was assessed in both groups using a structured questionnaire and 12-month expenditure data. Statistical analysis employed an unpaired sample t-test, Mann-Whitney U test, and chi-square test. A total of 117 patients aged 71.4±4.7 years were included in the study. The telemonitoring intervention incurred an annual infrastructure costs of €489.4 and operational costs of €97.3 (95% CI 85.7-109.0) per patient. Patient annual participation costs were €215.6 (95% CI 190.9-241.1). Average annual out-of-pocket costs for both groups were €345 (95% CI 221-469). After 12 months the telemonitoring group reported significantly lower out-of-pocket costs (€132 vs. €545, p<0.001), driven by reduced spending on food, dietary supplements, medical equipment, and specialist check-ups compared to the standard care group. To optimise the cost structure of telemonitoring, strategies like shortening the telemonitoring period, developing a national telemonitoring platform, using patient devices, integrating artificial intelligence into platforms, and involving nurse practitioners as telemedicine centre coordinators should be explored.

Association Between Participation in a Heart Failure Telemonitoring Program and Health Care Utilization and Death Within an Integrated Health Care Delivery System

BackgroundThe clinical usefulness of remote telemonitoring to reduce postdischarge health care use and death in adults with heart failure (HF) remains controversial. Methods and ResultsWithin a large integrated health care delivery system, we matched patients enrolled in a postdischarge telemonitoring intervention from 2015 to 2019 to patients not receiving telemonitoring at up to a 1:4 ratio on age, sex, and calipers of a propensity score. Primary outcomes were readmissions for worsening HF and all-cause death within 30, 90, and 365 days of the index discharge; secondary outcomes were all-cause readmissions and any outpatient diuretic dose adjustments. We matched 726 patients receiving telemonitoring to 1985 controls not receiving telemonitoring, with a mean age of 75 ± 11 years and 45% female. Patients receiving telemonitoring did not have a significant reduction in worsening HF hospitalizations (adjusted rate ratio [aRR] 0.95, 95% confidence interval [CI] 0.68–1.33), all-cause death (adjusted hazard ratio 0.60, 95% CI 0.33–1.08), or all-cause hospitalization (aRR 0.82, 95% CI 0.65–1.05) at 30 days, but did have an increase in outpatient diuretic dose adjustments (aRR 1.84, 95% CI 1.44–2.36). All associations were similar at 90 and 365 days postdischarge. ConclusionsA postdischarge HF telemonitoring intervention was associated with more diuretic dose adjustments but was not significantly associated with HF-related morbidity and mortality.

Distance Monitoring of Advanced Cancer Patients with Impaired Cardiac and Respiratory Function Assisted at Home: A Study Protocol in Italy.

During the pandemic, telemedicine and telehealth interventions have been leading in maintaining the continuity of care independently of patients' physical location. However, the evidence available about the effectiveness of the telehealth approach for advanced cancer patients with chronic disease is limited. This interventional randomized pilot study aims to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home. The purpose of the current paper is to describe the design of the telemonitoring intervention in a home palliative and supportive care setting with the objective of optimizing the management of patients, improving both their quality of life and psychological status and the caregiver's perceived care burden. This study may improve scientific knowledge regarding the impact of telemonitoring. Moreover, this intervention could foster continuous healthcare delivery and closer communication among the physician, patient and family, enabling the physician to have an updated overview of the clinical trajectory of the disease. Finally, the study may help family caregivers to maintain their habits and professional position and to limit financial consequences.

The potential of blood pressure telemonitoring: experience in the UK and Japan.

Hypertension is the most important and modifiable risk factor for cardiovascular disease (CVD) morbidity and mortality worldwide, and a growing issue as the global population with hypertension increases (estimated to be 626 million women and 652 million men in 2019, almost double the number in 1990). In addition, global control rates for hypertension remain poor: 23% for women and 18% for men in 2019 (Lancet. 2021:957). Measures to reduce the number of poorly controlled hypertensive patients are urgently needed. Remarkable advances in healthcare technology have changed healthcare delivery dramatically in the last decade with out-of-office blood pressure (BP) telemonitoring being widely used in clinical research (Hypertension. 2020:1368). We have demonstrated the efficacy of BP telemonitoring and digital intervention for the management of hypertension in the Telemonitoring And Self-Management IN the control of Hypertension (TASMINH) trials (Lancet. 2010:163, JAMA. 2014:799, Lancet. 2018:949), the Home and Online Management and Evaluation of Blood Pressure (HOME BP) trial (BMJ. 2021:m4858), and the HERB Digital Hypertension 1(HERB-DH1) pivotal trial (Eur Heart J. 2021:4111). A recent meta-analysis found that home BP telemonitoring improved office systolic BP (SBP) by 3.99 mmHg and home BP telemonitoring plus additional support (e.g., counselling and medications management) also showed a reduction of office SBP by 2.44 mmHg versus home BP telemonitoring alone (J Hum Hypertens. 2017:427). This evidence suggests that BP telemonitoring is an optimal tool for reducing BP levels and that combining BP telemonitoring and co-interventions would be the most effective approach for the management of hypertension. There are additional benefits from BP telemonitoring system in clinical practice, including assessment of accurate and reliable out-of-office BP data, and ease of BP measurement and recording by patients without the need for manual systems. Furthermore, such systems can reduce nonadherence of antihypertensive medications and clinical inertia, both of which contribute to a treatment-resistant hypertension (J Hypertens. 2017:2346, J Hypertens. 2021:1238). In practical terms, telemonitoring also facilitates optimal BP management for patients living in geographically remote or poorly medically resourced areas (Hypertension. 2021:1927). In this session, through discussion of the evidence base and clinical experience in the UK and Japan, we will examine the prospects of BP telemonitoring systems for the future management of hypertension. We will examine how BP telemonitoring systems are used and affect BP control in both clinical trials and subsequent implementation. In addition, by comparing such work in the UK and Japan, we will assess the potential of BP telemonitoring systems as a solution to the inadequate BP control status worldwide.

Effect of telemonitoring and telerehabilitation on physical activity, exercise capacity, health-related quality of life and healthcare use in patients with chronic lung diseases or COVID-19: A scoping review

Background Telemonitoring and telerehabilitation can support home-based pulmonary rehabilitation (PR) and benefit patients with lung diseases or COVID-19. This study aimed to (1) identify which telemonitoring and telerehabilitation interventions (e.g. videoconferencing) are used to provide telehealth care for people with chronic respiratory conditions or COVID-19, and (2) provide an overview of the effects of telemonitoring and telerehabilitation on exercise capacity, physical activity, health-related QoL (HRQoL), and healthcare use in patients with lung diseases or COVID-19. Methods A search was performed in the electronic databases of Ovid MEDLINE, EMBASE, and Cinahl through 15 June 2021. Subject heading and keywords were used to reflect the concepts of telemonitoring, telerehabilitation, chronic lung diseases, and COVID-19. Studies that explored the effect of a telerehabilitation and/or telemonitoring intervention, in patients with a chronic lung disease such as asthma, chronic obstructive pulmonary diseases (COPD), or COVID-19, and reported the effect of the intervention in one or more of our outcomes of interest were included. Excluding criteria included evaluation of new technological components, teleconsultation or one-time patient assessment. Results This scoping review included 44 publications reporting the effect of telemonitoring (25 studies), telerehabilitation (8 studies) or both (11 studies) on patients with COPD (35 studies), asthma (5 studies), COPD and asthma (1 study), and COVID-19 (2 studies). Patients who received telemonitoring and/or telerehabilitation had improvements in exercise capacity in 9 out of 11 (82%) articles, better HRQoL in 21 out of 25 (84%), and fewer health care use in 3 out of 3 (100%) articles compared to pre-intervention. Compared to controls, no statistically significant differences were found in the intervention groups’ exercise capacity in 5 out 6 (83%) articles, physical activity in 3 out of 3 (100%) articles, HRQoL in 21 out of 25 (84%) articles, and healthcare use in 15 out of 20 (75%) articles. The main limitation of the study was the high variability between the characteristics of the studies, such as the number and age of the patients, the outcome measures, the duration of the intervention, the technological components involved, and the additional elements included in the interventions that may influence the generalization of the results. Conclusion Telemonitoring and telerehabilitation interventions had a positive effect on patient outcomes and appeared to be as effective as standard care. Therefore, they are promising alternatives to support remote home-based rehabilitation in patients with chronic lung diseases or COVID-19.

Patient Perspectives of a Non-Invasive Telemonitoring Tool for Patients with Heart Failure.

AimAdvancements in telemonitoring (TM) for patients with heart failure (HF) are incongruous because of the effect of TM intervention and various types of TM. This study aimed to clarify patients’ experiences in using the TM tool.MethodsThis was a qualitative study. Data were evaluated using qualitative content analysis. Nine patients with heart failure → HF participated and completed the 1-month study period.ResultsThe experience of this TM tool was determined using semi-structured interviews followed by qualitative content analysis. Finally, five themes emerged: habituation of self-care behaviour, no burden for use, a feeling of security, additional functions and advice rather than guidance.ConclusionThis TM tool is easy to use and has the potential to promote self-management in patients with HF. Based on the aforementioned findings, we revised this tool and added some functions and will perform additional tests.

Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission.

AimsTo evaluate a telemonitoring strategy based on automated text messaging and telephone support after heart failure (HF) hospitalization.Methods and resultsThe MESSAGE‐HF study is a prospective multicentre, randomized, nationwide trial enrolling patients from 30 clinics in all regions of Brazil. HF patients with reduced left ventricular ejection fraction (<40%) and access to mobile phones are eligible after an acute decompensated HF hospitalization. Patients meeting eligibility criteria undergo an initial feasibility text messaging assessment and are randomized to usual care or telemonitoring intervention. All patients receive a HF booklet with basic information and recommendations about self‐care. Patients in the intervention group receive four daily short text messages (educational and feedback) during the first 30 days of the protocol to optimize self‐care; the feedback text messages from patients could trigger diuretic adjustments or a telephone call from the healthcare team. After 30 days, the frequency of text messages can be adjusted. Patients are followed up after 30, 90, and 180 days, with final status ascertained at 365 days by telephone. Our primary endpoint is the change in N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) levels after 180 days. Secondary endpoints include changes in NT‐proBNP after 30 days; health‐related quality of life, HF self‐care, and knowledge scales after 30 and 180 days; and a composite outcome of HF hospitalization and cardiovascular death, adjudicated by a blinded and independent committee.ConclusionsThe MESSAGE‐HF trial is evaluating an educational and self‐care promotion strategy involving a simple, intensive, and tailored telemonitoring system. If proven effective, it could be applied to a broader population worldwide.

Patient Perspectives on Innovative Telemonitoring Enhanced Care Program for Chronic Heart Failure (ITEC-CHF): Usability Study.

BackgroundTelemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but little is known about the usability and patients’ willingness to engage with this technology.ObjectiveThis study aims to evaluate feedback from patients with CHF following participation in the Innovative Telemonitoring Enhanced Care program for CHF (ITEC-CHF) study.MethodsThe telemonitoring intervention consisted of three components: remote weight monitoring, structured telephone support, and nurse-led collaborative care. Participants were provided with electronic weighing scales (W550; ForaCare), and a computer tablet (Galaxy Tab A; Samsung). They were asked to weigh themselves on the provided scales daily. Telemonitoring was integrated with a personal assistance call service and a nurse care service according to their workflows in usual care. Feedback on the usability of ITEC-CHF was collected via survey from study participants following 6 months of receiving telemonitoring care for their body weight. Survey responses were provided on a 5-point Likert scale and through open-ended questions to determine participants’ perceived benefits and barriers to using ITEC-CHF.ResultsA total of 67 participants (49/67, 73% male), with a mean age of 69.8 (SD 12.4) years completed the survey. The majority of participants agreed or strongly agreed that the ITEC-CHF program was easy to use (61/67, 91%), easy to navigate (51/65, 78%), useful (59/65, 91%), and made them feel more confident in managing their weight (57/67, 85%). Themes related to participants’ perceptions of telemonitoring included increased support for early intervention of clinical deterioration, improved compliance to daily weighing, a sense of reassurance, and improved self-care and accountability, among others.ConclusionsITEC-CHF was rated highly on usability and was well accepted by users as part of their routine self-management activities. Participants were willing to use telemonitoring because they perceived a broad spectrum of benefits for CHF management.Trial RegistrationAustralian New Zealand Clinical Trial Registry ID ACTRN 12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.

Domains and Methods Used to Assess Home Telemonitoring Scalability: Systematic Review.

BackgroundThe COVID-19 pandemic catalyzed the adoption of home telemonitoring to cope with social distancing challenges. Recent research on home telemonitoring demonstrated benefits concerning the capacity, patient empowerment, and treatment commitment of health care systems. Moreover, for some diseases, it revealed significant improvement in clinical outcomes. Nevertheless, when policy makers and practitioners decide whether to scale-up a technology-based health intervention from a research study to mainstream care delivery, it is essential to assess other relevant domains, such as its feasibility to be expanded under real-world conditions. Therefore, scalability assessment is critical, and it encompasses multiple domains to ensure population-wide access to the benefits of the growing technological potential for home telemonitoring services in health care.ObjectiveThis systematic review aims to identify the domains and methods used in peer-reviewed research studies that assess the scalability of home telemonitoring–based interventions under real-world conditions.MethodsThe authors followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines and used multiple databases (PubMed, Scopus, Web of Science, and EconLit). An integrative synthesis of the eligible studies was conducted to better explore each intervention and summarize relevant information concerning the target audience, intervention duration and setting, and type of technology. Each study design was classified based on the strength of its evidence. Lastly, the authors conducted narrative and thematic analyses to identify the domains, and qualitative and quantitative methods used to support scalability assessment.ResultsThis review evaluated 13 articles focusing on the potential of scaling up a home telemonitoring intervention. Most of the studies considered the following domains relevant for scalability assessment: problem (13), intervention (12), effectiveness (13), and costs and benefits (10). Although cost-effectiveness was the most common evaluation method, the authors identified seven additional cost analysis methods to evaluate the costs. Other domains were less considered, such as the sociopolitical context (2), workforce (4), and technological infrastructure (3). Researchers used different methodological approaches to assess the effectiveness, costs and benefits, fidelity, and acceptability.ConclusionsThis systematic review suggests that when assessing scalability, researchers select the domains specifically related to the intervention while ignoring others related to the contextual, technological, and environmental factors, which are also relevant. Additionally, studies report using different methods to evaluate the same domain, which makes comparison difficult. Future work should address research on the minimum required domains to assess the scalability of remote telemonitoring services and suggest methods that allow comparison among studies to provide better support to decision makers during large-scale implementation.

Effects of technology-enabled blood pressure monitoring in primary care: A quasi-experimental trial

Introduction Technology to enhance hypertension management is increasingly used in primary care; however, it has not been evaluated in an Asian primary care setting. We aimed to understand the clinical impact and cost-effectiveness of a technology-enabled home blood pressure monitor when deployed in primary care, and patients’ perspectives about the technology. Methods A quasi-experimental cohort study was conducted in a polyclinic in Singapore. In total, 120 patients with hypertension were assigned to the telemonitoring intervention group. Patients received a home blood pressure device connected to the clinical care team's dashboard through a mobile gateway. Tele-consultations and nurse-led tele-support were carried out using established clinical protocols. In total, 120 patients assigned to the control group continued to receive usual care in the polyclinic. Clinical outcomes, cost-effectiveness, and patient satisfaction were measured 6 months after recruitment. Results In total, 217 patients completed 6 months of follow-up. Telemonitoring intervention patients had significantly increased odds of having controlled blood pressure by a factor of 2.69 (p = 0.01), with the greatest improvement in those whose blood pressure was uncontrolled at baseline (p < 0.05). The incremental cost-effectiveness ratios for all patients was S$23,935.14/quality-adjusted life year (<1 gross domestic product per capita), which was very cost-effective based on World Health Organization cost-effectiveness thresholds. There was greater satisfaction in telemonitoring intervention group relating to the convenience of recording and sharing blood pressure measurements with the health care team, consultation advice received, understanding by the health care team of their condition, and were more motivated to monitor their blood pressure. Discussion Telemonitoring with tele-consultation improved blood pressure control and was more cost-effective than usual care. Patients receiving telemonitoring intervention were also more motivated and satisfied with their care.

Tailored or adapted interventions for adults with chronic obstructive pulmonary disease and at least one other long-term condition: a mixed methods review.

Tailored or adapted interventions for adults with chronic obstructive pulmonary disease and at least one other long-term condition: a mixed methods review.

A Telemonitoring Intervention for Cirrhotic Ascites Management Is Cost-Saving.

BackgroundPatients with cirrhosis and ascites experience frequent hospital admissions, leading to poor quality of life and high healthcare costs. Monitoring weight is a component of ascites care and telemonitoring may improve outcomes and costs.GoalsWe aimed to evaluate the cost and outcomes of current care compared to a telemonitoring system for ascites.StudyWe developed a decision-analytic model that examined 100 simulated patients over a 6-month horizon. We compared usual care to a new telemonitoring program, which we estimate costs $50,000/6 months.ResultsThe cost of standard of care for 100 patients with cirrhotic ascites over a 6-month period is $167,500 more expensive than telemonitoring. By varying parameter probabilities by ± 10% and outcome costs by ± 20%, we found that standard of care remains more expensive than care with a telemonitoring intervention by $9400 to $340,200 per 6-month period. Standard of care leads to 9 more admissions (range 4 to 12) than a telemonitoring intervention, while telemonitoring leads to 9 more outpatient visits (range 6 to 9) and 28 additional outpatient large volume paracenteses (LVPs) (range 17 to 28). With more and less expensive telemonitoring interventions, standard of care remained more expensive. With 50% adherence to the intervention, standard of care was $89,848 more expensive.ConclusionsIn almost all probability and cost scenarios, a telemonitoring intervention is cost-saving for the management of cirrhotic ascites. Using hospital admissions as a surrogate for quality of care, patient outcomes are improved primarily though more proactive medical intervention and more LVPs.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10620-021-07013-2.

E-Health solution for home patient telemonitoring in early post-acute TIA/Minor stroke during COVID-19 pandemic

BackgroundWhen it comes to critical early post-acute TIA/stroke phase, there is a lack of a comprehensive multi-parametric telemonitoring system. The COVID-19 emergency, its related global mobility restrictions and fear of hospitalization further highlighted the need of a comprehensive solution. ObjectiveWe aimed to design and test a pragmatic e-Health system based on multiparametric telemonitoring to support of TIA/stroke patients in sub-acute phase during the COVID-19 pandemic. MethodsWe proposed a telemonitoring system and protocol for TIA/minor stroke patients during COVID-19 pandemic for patients at risk of stroke recurrence. This system involves the use of portable devices for BP/HR/SpO2/temperature sensing, panic-button, gateway, and a dedicated ICT platform. The protocol is a 14-day multiparametric telemonitoring, therapy, and emergency intervention based on vital sign alteration notifications. We conducted a proof-of-concept validation test on 8 TIA/minor stroke patients in the early post-acute phase (< 14 days from ischemic event). ResultsThe proposed solution allowed to promptly and remotely identify vital sign alterations at home during the early post-acute phase, allowing therapy and behavioral intervention adjustments. Also, we observed a significant improvement of quality of life, as well as a significant reduction of anxiety and depression status. TUQ showed ease of use, good interface quality and high user satisfaction of the proposed solution. The 3-month follow-up showed total adherence of prescribed therapy and no stroke/TIA recurrence or other emergency department admissions. ConclusionThe proposed e-Health solution and telemonitoring protocol may be highly useful for early post-acute remote patient management, thus supporting constant monitoring and patient adherence to the treatment pathway, especially during the COVID-19 emergency.

Impact of a telemonitoring intervention in patients with chronic heart failure in Germany: A difference-in-difference matching approach using real-world data

Introduction The aim of this study was to evaluate the effects of a non-invasive telemonitoring intervention on mortality, healthcare costs, and hospital and pharmaceutical utilisation in patients with chronic heart failure (CHF) of a large statutory health insurer in Germany. Methods In a retrospective observational cohort study using real-world data, we assessed differences between 635 patients who received a telemonitoring intervention versus 635 receiving usual care covering 36 months after intervention. We used propensity score matching on a set of 102 parameters collected in the 24-month pre-intervention period to correct for observed differences, as well as difference-in-difference (DiD) estimators to account for unobserved differences. We analysed the effect of the intervention for up to three years on (i) all-cause mortality; (ii) costs (i.e. inpatient stays, ambulatory care, pharmaceuticals, and medical aids and appliances); and (iii) healthcare utilisation (i.e. length and number of hospital stays, number of prescriptions). Results DiD estimates suggest lower inpatient costs of the telemonitoring group of up to €1160 (95% confidence interval (CI): –2253 to –69) in year three. Ambulatory care costs increased significantly in all three years up to €316 (95% CI: 1267 to 505) per year. Telemonitoring had a positive effect on survival (hazard ratio = 0.71; 95% CI: 0.51 to 0.99) and increased the number of prescriptions for diuretics. Effects were more prominent for patients with severe CHF. Discussion The study suggests that the telemonitoring intervention led to a significant decrease in mortality and a shift in costs from the inpatient to the ambulatory care sector 36 months after intervention.

Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study

BackgroundHome telemonitoring is a promising approach to optimizing outcomes for patients with Type 2 Diabetes; however, this care strategy has not been adapted for use with understudied and underserved Hispanic/Latinos (H/L) patients with Type 2 Diabetes.MethodsA formative, Community-Based Participatory Research approach was used to adapt a home telemonitoring intervention to facilitate acceptability and feasibility for vulnerable H/L patients. Utilizing the ADAPT-ITT framework, key stakeholders were engaged over an 8-month iterative process using a combination of strategies, including focus groups and structured interviews. Nine Community Advisory Board, Patient Advisory, and Provider Panel Committee focus group discussions were conducted, in English and Spanish, to garner stakeholder input before intervention implementation.Focus groups and structured interviews were also conducted with 12 patients enrolled in a 1-month pilot study, to obtain feedback from patients in the home to further adapt the intervention. Focus groups and structured interviews were approximately 2 hours and 30 min, respectively. All focus groups and structured interviews were audio-recorded and professionally transcribed. Structural coding was used to mark responses to topical questions in the moderator and interview guides.ResultsTwo major themes emerged from qualitative analyses of Community Advisory Board/subcommittee focus group data. The first major theme involved intervention components to maximize acceptance/usability. Subthemes included tablet screens (e.g., privacy/identity concerns; enlarging font sizes; lighter tablet to facilitate portability); cultural incongruence (e.g., language translation/literacy, foods, actors “who look like me”); nursing staff (e.g., ensuring accessibility; appointment flexibility); and, educational videos (e.g., the importance of information repetition). A second major theme involved suggested changes to the randomized control trial study structure to maximize participation, including a major restructuring of the consenting process and changes designed to optimize recruitment strategies. Themes from pilot participant focus group/structured interviews were similar to those of the Community Advisory Board such as the need to address and simplify a burdensome consenting process, the importance of assuring privacy, and an accessible, culturally congruent nurse.ConclusionsThese findings identify important adaptation recommendations from the stakeholder and potential user perspective that should be considered when implementing home telemonitoring for underserved patients with Type 2 Diabetes.Trial registrationNCT03960424; ClinicalTrials.gov (US National Institutes of Health). Registered 23 May 2019. Registered prior to data collection. https://www.clinicaltrials.gov/ct2/show/NCT03960424?term=NCT03960424&draw=2&rank=1

Effects of Different Telemonitoring Strategies on Chronic Heart Failure Care: Systematic Review and Subgroup Meta-Analysis.

BackgroundTelemonitoring studies in chronic heart failure are characterized by mixed mortality and hospitalization outcomes, which have deterred the uptake of telemonitoring in clinical practice. These mixed outcomes may reflect the diverse range of patient management strategies incorporated in telemonitoring. To address this, we compared the effects of different telemonitoring strategies on clinical outcomes.ObjectiveThe aim of this systematic review and subgroup meta-analysis was to identify noninvasive telemonitoring strategies attributing to improvements in all-cause mortality or hospitalization outcomes for patients with chronic heart failure.MethodsWe reviewed and analyzed telemonitoring strategies from randomized controlled trials (RCTs) comparing telemonitoring intervention with usual care. For each strategy, we examined whether RCTs that applied the strategy in the telemonitoring intervention (subgroup 1) resulted in a significantly lower risk ratio (RR) of all-cause mortality or incidence rate ratio (IRR) of all-cause hospitalization compared with RCTs that did not apply this strategy (subgroup 2).ResultsWe included 26 RCTs (N=11,450) incorporating 18 different telemonitoring strategies. RCTs that provided medication support were found to be associated with a significantly lower IRR value than RCTs that did not provide this type of support (P=.01; subgroup 1 IRR=0.83, 95% CI 0.72-0.95 vs subgroup 2 IRR=1.02, 95% CI 0.93-1.12). RCTs that applied mobile health were associated with a significantly lower IRR (P=.03; IRR=0.79, 95% CI 0.64-0.96 vs IRR=1.00, 95% CI 0.94-1.06) and RR (P=.01; RR=0.67, 95% CI 0.53-0.85 vs RR=0.95, 95% CI 0.84-1.07).ConclusionsTelemonitoring strategies involving medication support and mobile health were associated with improvements in all-cause mortality or hospitalization outcomes. These strategies should be prioritized in telemonitoring interventions for the management of patients with chronic heart failure.

Evaluation of a Heart Failure Telemonitoring Program Through a Microsimulation Model: Cost-Utility Analysis.

BackgroundHeart failure (HF) is a major public health issue in Canada that is associated with high prevalence, morbidity, and mortality rates and high financial and social burdens. Telemonitoring (TM) has been shown to improve all-cause mortality and hospitalization rates in patients with HF. The Medly program is a TM intervention integrated as standard of care at a large Canadian academic hospital for ambulatory patients with HF that has been found to improve patient outcomes. However, the cost-effectiveness of the Medly program is yet to be determined.ObjectiveThis study aims to conduct a cost-utility analysis of the Medly program compared with the standard of care for HF in Ontario, Canada, from the perspective of the public health care payer.MethodsUsing a microsimulation model, individual patient data were simulated over a 25-year time horizon to compare the costs and quality-adjusted life years (QALYs) between the Medly program and standard care for patients with HF treated in the ambulatory care setting. Data were sourced from a Medly Program Evaluation study and literature to inform model parameters, such as Medly’s effectiveness in reducing mortality and hospitalizations, health care and intervention costs, and model transition probabilities. Scenario analyses were conducted in relation to HF severity and TM deployment models. One-way deterministic effectiveness analysis and probabilistic sensitivity analysis were performed to explore the impact on the results of uncertainty in model parameters.ResultsThe Medly program was associated with an average total cost of Can $102,508 (US $77,626) per patient and total QALYs of 5.51 per patient compared with the average cost of Can $97,497 (US $73,831) and QALYs of 4.95 per patient in the Standard Care Group. This led to an incremental cost of Can $5011 (US $3794) and incremental QALY of 0.566, resulting in an incremental cost-effectiveness ratio of Can $8850 (US $6701)/QALY. Cost-effectiveness improved in relation to patients with advanced HF and with deployment models in which patients used their own equipment. Baseline and alternative scenarios consistently showed probabilities of cost-effectiveness greater than 85% at a willingness-to-pay threshold of Can $50,000 (US $37,718). Although the results showed some sensitivity to assumptions about effectiveness parameters, the intervention was found to remain cost-effective.ConclusionsThe Medly program for patients with HF is cost-effective compared with standard care using commonly reported willingness-to-pay thresholds. This study provides evidence for decision makers on the use of TM for HF, supports the use of a nurse-led model of TM that embeds clinically validated algorithms, and informs the use of economic modeling for future evaluations of early-stage health informatics technology.

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P=0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P=0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.