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Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial.

ABSTRACT: OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C > or =7.5%. RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005, who were taking oral hypoglycemic agents and/or insulin for > or =1 year, and who had A1C > or =7.5% at enrollment were randomly assigned to either active care management with home telemonitoring (ACM+HT group, n = 73) or a monthly care coordination telephone call (CC group, n = 77). Both groups received monthly calls for diabetes education and self-management review. ACM+HT group participants transmitted blood glucose, blood pressure, and weight to a nurse practitioner using the Viterion 100 TeleHealth Monitor; the nurse practitioner adjusted medications for glucose, blood pressure, and lipid control based on established American Diabetes Association targets. Measures were obtained at baseline, 3-month, and 6-month visits. RESULTS Baseline characteristics were similar in both groups, with mean A1C of 9.4% (CC group) and 9.6% (ACM+HT group). Compared with the CC group, the ACM+HT group demonstrated significantly larger decreases in A1C at 3 months (1.7 vs. 0.7%) and 6 months (1.7 vs. 0.8%; P < 0.001 for each), with most improvement occurring by 3 months. CONCLUSIONS Compared with the CC group, the ACM+HT group demonstrated significantly greater reductions in A1C by 3 and 6 months. However, both interventions improved glycemic control in primary care patients with previously inadequate control.

SUBMITTER: Stone RA

PROVIDER: S-EPMC2827492 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial.

Stone Roslyn A RA Rao R Harsha RH Sevick Mary Ann MA Cheng Chunrong C Hough Linda J LJ Macpherson David S DS Franko Carol M CM Anglin Rebecca A RA Obrosky D Scott DS Derubertis Frederick R FR

Diabetes care 20091215 3

OBJECTIVE We compared the short-term efficacy of home telemonitoring coupled with active medication management by a nurse practitioner with a monthly care coordination telephone call on glycemic control in veterans with type 2 diabetes and entry A1C > or =7.5%. RESEARCH DESIGN AND METHODS Veterans who received primary care at the VA Pittsburgh Healthcare System from June 2004 to December 2005, who were taking oral hypoglycemic agents and/or insulin for > or =1 year, and who had A1C > or =7.5% at ...[more]

PMID: 20009091

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Project description:BackgroundSelf-monitoring of blood glucose among people with type 2 diabetes not treated with insulin does not appear to be effective in improving glycemic control. We investigated whether health professional review of telemetrically transmitted self-monitored glucose results in improved glycemic control in people with poorly controlled type 2 diabetes.Methods and findingsWe performed a randomized, parallel, investigator-blind controlled trial with centralized randomization in family practices in four regions of the United Kingdom among 321 people with type 2 diabetes and glycated hemoglobin (HbA1c) >58 mmol/mol. The supported telemonitoring intervention involved self-measurement and transmission to a secure website of twice-weekly morning and evening glucose for review by family practice clinicians who were not blinded to allocation group. The control group received usual care, with at least annual review and more frequent reviews for people with poor glycemic or blood pressure control. HbA1c assessed at 9 mo was the primary outcome. Intention-to-treat analyses were performed. 160 people were randomized to the intervention group and 161 to the usual care group between June 6, 2011, and July 19, 2013. HbA1c data at follow-up were available for 146 people in the intervention group and 139 people in the control group. The mean (SD) HbA1c at follow-up was 63.0 (15.5) mmol/mol in the intervention group and 67.8 (14.7) mmol/mol in the usual care group. For primary analysis, adjusted mean HbA1c was 5.60 mmol/mol / 0.51% lower (95% CI 2.38 to 8.81 mmol/mol/ 95% CI 0.22% to 0.81%, p = 0·0007). For secondary analyses, adjusted mean ambulatory systolic blood pressure was 3.06 mmHg lower (95% CI 0.56-5.56 mmHg, p = 0.017) and mean ambulatory diastolic blood pressure was 2.17 mmHg lower (95% CI 0.62-3.72, p = 0.006) among people in the intervention group when compared with usual care after adjustment for baseline differences and minimization strata. No significant differences were identified between groups in weight, treatment pattern, adherence to medication, or quality of life in secondary analyses. There were few adverse events and these were equally distributed between the intervention and control groups. In secondary analysis, there was a greater number of telephone calls between practice nurses and patients in the intervention compared with control group (rate ratio 7.50 (95% CI 4.45-12.65, p < 0.0001) but no other significant differences between groups in use of health services were identified between groups. Key limitations include potential lack of representativeness of trial participants, inability to blind participants and health professionals, and uncertainty about the mechanism, the duration of the effect, and the optimal length of the intervention.ConclusionsSupported telemonitoring resulted in clinically important improvements in control of glycaemia in patients with type 2 diabetes in family practice. Current Controlled Trials, registration number ISRCTN71674628.Trial registrationCurrent Controlled Trials ISRCTN 71674628.

Project description:BackgroundHeart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory.ObjectiveA randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization.MethodsHF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied.ResultsAdherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study.ConclusionsHome telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources.Trial registrationClinicaltrials.gov NCT01759368; http://clinicaltrials.gov/show/NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z).

Project description:BackgroundThe prevalence of diabetes is increasing among adults globally, and there is a need for new models of health care delivery. Research has shown that self-management approaches encourage persons with chronic conditions to take a primary role in managing their daily care.ObjectiveThe objective of this study was to investigate whether the introduction of a health technology-supported self-management program involving telemonitoring and health counseling had beneficial effects on glycated hemoglobin (HbA1c), other clinical variables (height, weight, body mass index, blood pressure, blood lipid profile), and health-related quality of life (HRQoL), as measured using the Short Form Health Survey (SF-36) version 2 in patients with type 2 diabetes.MethodsThis was a pragmatic randomized controlled trial of patients with type 2 diabetes. Both the control and intervention groups received usual care. The intervention group also participated in additional health promotion activities with the use of the Prescribed Healthcare Web application for self-monitoring of blood glucose and blood pressure. About every second month or when needed, the general practitioner or the diabetes nurse reviewed the results and the health care activity plan.ResultsA total of 166 patients with type 2 diabetes were randomly assigned to the intervention (n=87) or control (n=79) groups. From the baseline to follow-up, 36 patients in the intervention group and 5 patients in the control group were lost to follow-up, and 2 patients died. Additionally, HbA1c was not available at baseline in one patient in the intervention group. A total of 122 patients were included in the final analysis after 19 months. There were no significant differences between the groups in the primary outcome HbA1c level (P=.33), and in the secondary outcome HRQoL as measured using SF-36. A total of 80% (67/87) of the patients in the intervention group at the baseline, and 98% (47/50) of the responders after 19-month intervention were familiar with using a personal computer (P=.001). After 19 months, nonresponders (ie, data from baseline) reported significantly poorer mental health in social functioning and role emotional subscales on the SF-36 (P=.03, and P=.01, respectively).ConclusionsThe primary outcome HbA1c level and the secondary outcome HRQoL did not differ between groups after the 19-month follow-up. Those lost to follow-up reported significantly poorer mental health than did the responders in the intervention group.Trial registrationClinicaltrials.gov NCT01478672; https://clinicaltrials.gov/ct2/show/NCT01478672 (Archived by WebCite at http://www.webcitation.org/6r4eILeyu).

Project description:Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined.The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes.One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients' mobile phones and alerts to a cardiologist's mobile phone as required.Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant improvements from baseline to post-study in BNP (decreased by 150 pg/mL, P = .02), LVEF (increased by 7.4%, P = .005) and self-care maintenance (increased by 7 points, P = .05) and management (increased by 14 points, P = .03), while the control group did not. No differences were found between the telemonitoring and control groups in terms of hospitalization, mortality, or emergency department visits, but the trial was underpowered to detect differences in these metrics.Our findings provide evidence of improved quality of life through improved self-care and clinical management from a mobile phone-based telemonitoring system. The use of the mobile phone-based system had high adherence and was feasible for patients, including the elderly and those with no experience with mobile phones.ClinicalTrials.gov NCT00778986.

Project description:BackgroundConnected devices that allow people with diabetes to monitor their blood glucose levels remotely with data visualization have been shown to improve self-care behavior in diabetes management. However, their effectiveness and usability for a low-middle-income, racially diverse population are unknown.ObjectiveThis study aims to evaluate the effects of remote telemonitoring with team-based management on people with uncontrolled type 2 diabetes.DesignThis was a pragmatic 52-week cluster-randomized controlled study among 11 primary care government practices in Malaysia.ParticipantsPeople with type 2 diabetes aged 18 and above, who had hemoglobin A1c ??7.5% but less than 11.0% within the past 3 months and resided in the state of Selangor.InterventionThe intervention group received home gluco-telemonitors and transmitted glucose data to a care team who could adjust therapy accordingly. The team also facilitated self-management by supporting participants to improve medication adherence, and encourage healthier lifestyle and use of resources to reduce risk factors. Usual care group received routine healthcare service.Main measureThe primary outcome was the change in HbA1c at 24 weeks and 52 weeks. Secondary outcomes included change in fasting plasma glucose, blood pressure, lipid levels, health-related quality of life, and diabetes self-efficacy.ResultsA total of 240 participants were recruited in this study. The telemonitoring group reported larger improvements in glycemic control compared with control at the end of study (week 24, -?0.05%; 95% CI -?0.10 to 0.00%) and at follow-up (week 52, -?0.03%; -?0.07 to 0.02%, p?=?0.226). Similarly, no differences in other secondary outcomes were observed, including the number of adverse events and health-related quality of life.ConclusionThis study indicates that there is limited benefit of replacing telemedicine with the current practice of self-monitoring of blood glucose. Further innovative methods to improve patient engagement in diabetes care are needed.Trial registrationClinicalTrials.gov identifier: NCT02466880.

Project description:BackgroundDiabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management.ObjectiveTo examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension.MethodsA 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management.ResultsOutcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers.ConclusionThe potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada.Trial registrationClinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).

Project description:BackgroundMost health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial.MethodsFour-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes.ResultsOf 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes.ConclusionsHealth TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others.Trial registrationClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.

Project description:BACKGROUND:Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), but the objective assessment of patient compliance with self-management recommendations has seldom been studied. OBJECTIVE:This study aimed to evaluate patient compliance with self-management recommendations of an innovative telemonitoring enhanced care program for CHF (ITEC-CHF). METHODS:We conducted a multicenter randomized controlled trial with a 6-month follow-up. The ITEC-CHF program comprised the provision of Bluetooth-enabled scales linked to a call center and nurse care services to assist participants with weight monitoring compliance. Compliance was defined a priori as weighing at least 4 days per week, analyzed objectively from weight recordings on the scales. The intention-to-treat principle was used to perform the analysis. RESULTS:A total of 184 participants (141/184, 76.6% male), with a mean age of 70.1 (SD 12.3) years, were randomized to receive either ITEC-CHF (n=91) or usual care (control; n=93), of which 67 ITEC-CHF and 81 control participants completed the intervention. For the compliance criterion of weighing at least 4 days per week, the proportion of compliant participants in the ITEC-CHF group was not significantly higher than that in the control group (ITEC-CHF: 67/91, 74% vs control: 56/91, 60%; P=.06). However, the proportion of ITEC-CHF participants achieving the stricter compliance standard of at least 6 days a week was significantly higher than that in the control group (ITEC-CHF: 41/91, 45% vs control: 23/93, 25%; P=.005). CONCLUSIONS:ITEC-CHF improved participant compliance with weight monitoring, although the withdrawal rate was high. Telemonitoring is a promising method for supporting both patients and clinicians in the management of CHF. However, further refinements are required to optimize this model of care. TRIAL REGISTRATION:Australian New Zealand Clinical Trial Registry ACTRN12614000916640; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366691.

Project description:Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement.We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points.For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans.Clinical Trials.gov Identifier: NCT00384748.

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Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial.

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Active care management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized controlled trial.

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