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Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial.

ABSTRACT: Web-based personal health records (PHRs) have been advocated as a means to improve type 2 diabetes mellitus (DM) care. However, few Web-based systems are linked directly to the electronic medical record (EMR) used by physicians.We randomized 11 primary care practices. Intervention practices received access to a DM-specific PHR that imported clinical and medications data, provided patient-tailored decision support, and enabled the patient to author a "Diabetes Care Plan" for electronic submission to their physician prior to upcoming appointments. Active control practices received a PHR to update and submit family history and health maintenance information. All patients attending these practices were encouraged to sign up for online access.We enrolled 244 patients with DM (37% of the eligible population with registered online access, 4% of the overall population of patients with DM). Study participants were younger (mean age, 56.1 years vs 60.3 years; P < .001) and lived in higher-income neighborhoods (median income, $53,784 vs $49,713; P < .001) but had similar baseline glycemic control compared with nonparticipants. More patients in the intervention arm had their DM treatment regimens adjusted (53% vs 15%; P < .001) compared with active controls. However, there were no significant differences in risk factor control between study arms after 1 year (P = .53).Previsit use of online PHR linked to the EMR increased rates of DM-related medication adjustment. Low rates of online patient account registration and good baseline control among participants limited the intervention's impact on overall risk factor control.clinicaltrials.gov Identifier: NCT00251875.

SUBMITTER: Grant RW

PROVIDER: S-EPMC3829635 | biostudies-literature | 2008 Sep

REPOSITORIES: biostudies-literature

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Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial.

Grant Richard W RW Wald Jonathan S JS Schnipper Jeffrey L JL Gandhi Tejal K TK Poon Eric G EG Orav E John EJ Williams Deborah H DH Volk Lynn A LA Middleton Blackford B

Archives of internal medicine 20080901 16

<h4>Background</h4>Web-based personal health records (PHRs) have been advocated as a means to improve type 2 diabetes mellitus (DM) care. However, few Web-based systems are linked directly to the electronic medical record (EMR) used by physicians.<h4>Methods</h4>We randomized 11 primary care practices. Intervention practices received access to a DM-specific PHR that imported clinical and medications data, provided patient-tailored decision support, and enabled the patient to author a "Diabetes C ...[more]

PMID: 18779465

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Project description:Background and objectivesPatient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record-based enhanced personal health record to disseminate CKD stage-specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator program for patients with CKD with enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4.Design, setting, participants, & measurementsTwo hundred and nine patients from six outpatient clinics (in both primary care and nephrology settings) were randomized in a 2×2 factorial design into four-study groups: (1) enhanced personal health record only, (2) patient navigator only, (3) both, and (4) usual care (control) group. Primary outcome measure was the change in eGFR over a 2-year follow-up period. Secondary outcome measures included acquisition of appropriate CKD-related laboratory measures, specialty referrals, and hospitalization rates.ResultsMedian age of the study population was 68 years old, and 75% were white. At study entry, 54% of patients were followed by nephrologists, and 88% were on renin-angiotensin system blockers. After a 2-year follow-up, rate of decline in eGFR was similar across the four groups (P=0.19). Measurements of CKD-related laboratory parameters were not significantly different among the groups. Furthermore, referral for dialysis education and vascular access placement, emergency room visits, and hospitalization rates were not statistically significant different between the groups.ConclusionsWe successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD.

Project description:BackgroundNational guidelines for managing diabetes set standards for care. We sought to determine whether a 1-year intensive multitherapy program resulted in greater goal attainment than usual care among patients with poorly controlled type 2 diabetes mellitus.MethodsWe identified patients with poorly controlled type 2 diabetes receiving outpatient care in the community or at our hospital. Patients 30-70 years of age with a hemoglobin A1c concentration of 8% or greater were randomly assigned to receive intensive multitherapy (n = 36) or usual care (n = 36).ResultsThe average hemoglobin A1c concentration at entry was 9.1% (standard deviation [SD] 1%) in the intensive therapy group and 9.3% (SD 1%) in the usual therapy group. By 12 months, a higher proportion of patients in the intensive therapy group than in the control group had achieved Canadian Diabetes Association (CDA) goals for hemoglobin A(1c) concentrations (goal < or = 7.0%: 35% v. 8%), diastolic blood pressure (goal < 80 mm Hg: 64% v. 37%), low-density lipoprotein cholesterol (LDL-C) levels (goal < 2.5 mmol/L: 53% v. 20%) and triglyceride levels (goal < 1.5 mmol/L: 44% v. 14%). There were no significant differences between the 2 groups in attaining the targets for fasting plasma glucose levels, systolic blood pressure or total cholesterol:high-density lipoprotein cholesterol ratio. None of the patients reached all CDA treatment goals. By 18 months, differences in goal attainment were no longer evident between the 2 groups, except for LDL-C levels. Quality of life, as measured by a specific questionnaire, increased in both groups, with a greater increase in the intensive therapy group (13% [SD 10%] v. 6% [SD 13%], p < 0.003).InterpretationIntensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association. However, 6 months after intensive therapy stopped and patients returned to usual care, the benefits had vanished.

Project description:BackgroundType 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM.MethodsA parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential.ResultsForty participants (Mage = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity.ConclusionsThe study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements.Trial registrationISRCTN, ISRCTN67421464 . Registered 17/12/2018.

Project description:BACKGROUND:This study was designed to evaluate the efficiency and tolerability of empagliflozin (EMPA) as monotherapy or add-on to existing therapy in patients with type 2 diabetes mellitus (T2DM). METHODS:Randomized controlled trials (RCTs) comparing efficacy and safety of EMPA vs placebo or EMPA plus other antidiabetes drugs vs placebo plus other oral antidiabetes drugs (OADs) in T2DM were recruited from electronic database Pubmed, Web of Knowledge, and Cochrane Central Register of Controlled Trials (CENTRAL), supplemented by a hand search of the reference lists of selected articles. Main effect sizes were change from baseline on glycemia control, body weight, blood pressure, and complications (i.e., incidence of urinary and genital tract infections, and morbidity of hypoglycemia and hyperglycemia). Random-effects model was used to account for clinical or methodologic heterogeneity across studies. RESULTS:Fifteen RCTs with a total number of 7891 individuals (5374 in EMPA group and 2517 in control group) were suitable for this meta-analysis. The results demonstrated that significant improvements in glycemia control, body weight, and blood pressure were associated with EMPA application (i.e., monotherapy and add-on therapy) in patient with T2DM when compared with placebo. Meanwhile, EMPA 10 and 20?mg improved glycemia, body weight, and blood pressure control for patients with T2DM. There was no significant difference in incidence of hypoglycemia and urinary tract infections across EMPA and placebo group. Significant reduced risk of hyperglycemia was revealed in EMPA group vs placebo (risk ratio: 0.34, 95%confidence interval: 0.23-0.49, P?<?.00001), except in patients on background insulin therapy. However, increased risk of genital infection was noted across EMPA vs placebo (risk ratio: 2.59, 95% confidence interval: 1.80-3.71, P?<?.00001). CONCLUSION:Our evidence supports the application of EMPA in treatment of patients with T2DM who are obesity or at risk of weight gain.

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Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial.

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Practice-linked online personal health records for type 2 diabetes mellitus: a randomized controlled trial.

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