An Internet-based health gateway device for interactive communication and automatic data uploading: Clinical efficacy for type 2 diabetes in a multi-centre trial

2016 ◽  
Vol 23 (6) ◽  
pp. 595-604 ◽  
Author(s):  
Jae Hyoung Cho ◽  
Hun-Sung Kim ◽  
Seung Hyun Yoo ◽  
Chang Hee Jung ◽  
Woo Je Lee ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare System ◽  
Glucose Control ◽  
Large Scale ◽  
Diabetes Management ◽  
Intervention Group ◽  
Diabetes Control ◽  
Control Group ◽  
Anthropometric Parameters ◽  
Automatic Data

Introduction The aim of this study was to improve the quality of diabetes control and evaluate the efficacy of an Internet-based integrated healthcare system for diabetes management and safety. Methods We conducted a large-scale, multi-centre, randomized clinical trial involving 484 patients. Patients in the intervention group ( n = 244) were treated with the Internet-based system for six months, while the control group ( n = 240) received the usual outpatient management over the same period. HbA1c, blood chemistries, anthropometric parameters, and adverse events were assessed at the beginning of the study, after three months, and the end of the study. Results There were no initial significant differences between the groups with respect to demographics and clinical parameters. Upon six-month follow-up, HbA1c levels were significantly decreased from 7.86 ± 0.69% to 7.55 ± 0.86% within the intervention group ( p < 0.001) compared to 7.81 ± 0.66% to 7.70 ± 0.88% within the control group. Postprandial glucose reduction was predominant. A subgroup with baseline HbA1c higher than 8% and good compliance achieved a reduction of HbA1c by 0.8 ± 1.05%. Glucose control and waist circumference reduction were more effective in females and subjects older than 40 years of age. There were no adverse events associated with the intervention. Discussion This e-healthcare system was effective for glucose control and body composition improvement without associated adverse events in a multi-centre trial. This system may be effective in improving diabetes control in the general population.

scholarly journals Effectiveness of a clinic-based randomized controlled intervention for type 2 diabetes management: an innovative model of intensified diabetes management in Mainland China (C-IDM study)

2020 ◽  
Vol 8 (1) ◽  
pp. e001030 ◽  
Author(s):  
Qinglin Lou ◽  
Qing Ye ◽  
Haidi Wu ◽  
Zhiyong Wang ◽  
Robert S Ware ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Large Scale ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mainland China ◽  
Outcome Variable ◽  
Control Group ◽  
Randomized Controlled

ObjectivesHighly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.Research design and methodsA 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.ResultsOverall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).ConclusionsThe C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.Trial registration numberChiCTR-IOR-15006019.

scholarly journals Benefit of Digital Tools Used for Integrated Personalized Diabetes Management: Results From the PDM-ProValue Study Program

2019 ◽  
Vol 14 (2) ◽  
pp. 240-249
Author(s):  
Lutz Heinemann ◽  
Wendelin Schramm ◽  
Helena Koenig ◽  
Annette Moritz ◽  
Iris Vesper ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
Diabetes Management ◽  
Intervention Group ◽  
Digital Tools ◽  
Clinical Inertia ◽  
Control Group ◽  
Traffic Light ◽  
Study Program ◽  
Therapeutic Concept ◽  
Cluster Randomized

Background: Integrated personalized diabetes management (iPDM) is a digitally supported therapeutic concept to improve patient-physician interaction to overcome the aspects of clinical inertia. Integrated personalized diabetes management can support decision making and improve therapeutic outcomes of suboptimally controlled persons with insulin-treated type 2 diabetes (T2D). In this paper, we report the results of an analysis of the PDM-ProValue study program on the effectiveness and perceived benefit of this approach, with a focus on how physicians used and assessed the digital tools provided for the iPDM process. Materials and Methods: The study program included two 12-month, prospective, controlled, cluster-randomized multicenter trials. A total of 101 practices participated with 907 patients. Practices were cluster-randomized to an intervention group and a control group. Digital tools for data visualization and analysis applied were used. HCP were asked to assess the use, relevance, and usefulness of the tools. Results: A clear preference was stated for the visual overview over more statistically complex analyses. A total of 83% of the participants rated a high relevance of the “daily profile,” 81% of the “total profile,” and 68% the “risk illustrated by traffic light symbols” for the therapy decision. The overall iPDM process was very favorably rated with respect to structuredness and potential for personalized treatment and well accepted among health care professionals (HCP). Conclusions: Embedding digital tools in a structured process (iPDM) were proved to provide a benefit for insulin-treated T2D patients and their physicians. These results offer insight for further development and improvement of the tools and add information on how to overcome clinical inertia.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

scholarly journals Clean Air Act mitigate the cognitive deterioration in older adults

2021 ◽  
Author(s):  
Yao Yao ◽  
Xiaozhen Lv ◽  
Chengxuan Qiu ◽  
Jiajianghui Li ◽  
Xiao Wu ◽  
...  
Keyword(s):  
Air Pollution ◽  
Cognitive Aging ◽  
Large Scale ◽  
Mmse Score ◽  
Intervention Group ◽  
Clean Air Act ◽  
Control Group ◽  
Cognitive Deterioration ◽  
Clean Air ◽  
The Government

Abstract Air pollution may accelerate cognitive aging, it is unclear whether large-scale interventions by Clean Air Act can mitigate the cognitive deterioration. Here, we conducted a difference-in-differences analysis based on Chinese Longitudinal Healthy Longevity Survey during 2014 and 2018. Intervention group came from where the government set a strict target of reducing air pollution, whereas control group lived in areas without reduction target. Global cognitive functions were measured using the Mini-Mental State Examination (MMSE). We found the intervention group with implementing Clean Air Act had a significantly smaller decline in MMSE score compared to the control group. Interquartile increases in PM2.5 and SO2 concentrations were significantly associated with a faster decline of MMSE score by 1.78 and 0.92 points, respectively. Implementing stringent clean air policies, especially in low- and middle-income countries may mitigate the risk of cognitive aging in older people.

scholarly journals Sauna Yoga Superiorly Improves Flexibility, Strength, and Balance: A Two-Armed Randomized Controlled Trial in Healthy Older Adults

2019 ◽  
Vol 16 (19) ◽  
pp. 3721 ◽  
Author(s):  
Bucht ◽  
Donath
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Intervention Group ◽  
Control Group ◽  
Minimization Method ◽  
Important Indicator ◽  
Randomized Controlled ◽  
Eyes Closed ◽  
Healthy Elderly

Besides strength and balance, flexibility is an important indicator of health-related physical fitness. Thus, the aim of this two-armed randomized controlled pilot trial was to investigate whether sauna yoga at a moderate temperature (50 °C) beneficially affects flexibility, strength, balance, and quality of life (QOL) in healthy elderly community dwellers. Participants were randomly assigned to an intervention group (INT, n = 11, age: 68.7 ± 5.9) or control group (CON, n = 12, age: 69.3 ± 4.9), using the minimization method. Age, physical activity, gender, and the primary outcome flexibility were used as strata for group allocation. Both groups completed similar exercises in the sauna over eight weeks. Only the INT group was exposed to moderate temperatures of 50 °C. Large and statistically significant improvement in favor of the sauna group (INT) was observed for the chair sit-and-reach test (INT: +83%, CON +3%, p = 0.028, nр² = 0.24). The shoulder and lateral spine flexibility were not relevantly affected. Strength in the lower extremities merely showed a tendency to significant changes (INT: 16%, CON: 3%, p = 0.061, nр² = 0.181). Additionally, balance abilities, with eyes closed, improved (INT: 187%, CON +58%, p = 0.056, nр² = 0.189) in favor of the INT group. QOL only improved in favor of the INT for environmental dimension (INT: +7%, CON: 0%, p = 0.034, nр² = 0.227). These first but preliminary findings indicate that sauna yoga may serve as a promising and feasible means to improve flexibility in elderly people. Strength and balance do not meaningfully benefit from a sauna environment, although strength improved to a slightly higher extent in the sauna group. Future large-scale research is needed to elucidate underlying mechanisms and corroborate these findings

scholarly journals Testing the Effectiveness of a Mixed-Method Pilot Intervention in Reducing Risky Driving Due to Aggression and Stress

Safety ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. 11
Author(s):  
Maria Papadakaki ◽  
Nikolaos Stamou ◽  
Stefanos Bessas ◽  
Stavroula Lioliou ◽  
Jooannes Chliaoutakis
Keyword(s):  
Mixed Method ◽  
Large Scale ◽  
Driving Simulator ◽  
Intervention Group ◽  
Cognitive Restructuring ◽  
Driving Performance ◽  
Control Group ◽  
Driving Behaviors ◽  
Experiential Instruction ◽  
Pilot Intervention

The study aimed at testing the effectiveness of a mixed-method pilot intervention in reducing risky self-reported driving performance, upon addressing stress and aggression while driving. The study recruited individuals who had performed these behaviors during the year preceding the study and allocated them into an intervention (n = 10) and a control group (n = 30). A pre-and postintervention evaluation design was employed to explore changes in risky self-reported driving behaviors, 12 months after the intervention. The intervention involved 2 h of experiential instruction and 1 h of cognitive restructuring using a driving simulator and scenarios appropriate for the processing of driving stress, aggression, and risk. The intervention group displayed significant improvements in the scales of “Hazard Monitoring” (p = 0.037) and “Covered Violations” (p = 0.049) at the postintervention level. No statistically significant differences were identified in terms of self-reported driving performance between the intervention and the control group at postintervention level. Launching large-scale experimental surveys with broadened cognitive restructuring approaches seems important to deepen our understanding of the behavioral change processes and increase the effectiveness of future interventions.

Corticosteroid as an Adjunct in the Treatment of Endobronchial Tuberculosis: A Systematic Review & Meta-analysis

2020 ◽  
Vol 16 (1) ◽  
pp. 53-60
Author(s):  
Nihar R. Mishra ◽  
Manoj K. Panigrahi ◽  
Girish C. Bhatt ◽  
Rashmi R. Das
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Intervention Group ◽  
Oral Prednisolone ◽  
Oral Steroid ◽  
Control Group ◽  
Eligibility Criteria ◽  
Steroid Group ◽  
Significant Difference ◽  
Endobronchial Tuberculosis

Background: Corticosteroid exerts anti-inflammatory action and can prevent tissue damage resulting from various causes. Studies have shown that corticosteroids may prevent the damaging effect of tuberculosis (TB) in various organs, but there is no published meta-analysis specifically looking for the effect of corticosteroid in endobronchial TB. Objective: To synthesize the evidence regarding the usefulness of corticosteroid in endo-bronchial TB. Methods: A comprehensive search was performed of the major electronic databases till 30th November 2018. Randomized trials comparing treatment with corticosteroid as an adjunct to antitubercular drugs (ATT) versus placebo/no treatment in endobronchial TB were included. Three authors independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data. The review is registered at PROSPERO database [CRD42016047063]. Results: Out of 525 search results, 4 trials including 205 patients (151 children) were eligible for inclusion. Oral prednisolone was used in various dose schedules. Rifampicin containing ATT regimen was used in 3 trials. The bronchoscopy findings showed no significant improvement at 1 month (effect size could not be calculated due to 0 event in the intervention group, p = 0.05), 2 months (RR 1.26, 95% CI 0.89 to 1.8), and at completion of ATT (RR 0.63, 95% CI 0.1 to 4.14) in steroid-treated group compared to the control group. The need for repeat bronchoscopy was significantly decreased in the steroid group (RR 0.13, 95% CI 0.02 to 0.9). Among the adverse events, the infection rate was significantly lesser in the steroid group (RR 0.53, 95% CI 0.29 to 0.97); but other adverse events (mortality, hypertension, and abdominal distension) showed no significant difference between the two groups. The GRADE evidence generated was of very low quality. Conclusions: The present meta-analysis showed that oral steroid does not help patients with endobronchial tuberculosis. However, the quality of evidence was very low. Future trials with robust design and a larger sample size would be required to provide any firm recommendation regarding the use of oral prednisolone in endobronchial tuberculosis.

scholarly journals Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Green Tea ◽  
Case Reports ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

Follow-up Intervention: Its Effect on Compliance Behavior to a Diabetes Regimen

1990 ◽  
Vol 16 (4) ◽  
pp. 291-295 ◽  
Author(s):  
Angela L. Estey ◽  
Meng H. Tan ◽  
Karen Mann
Keyword(s):  
Home Visit ◽  
Diabetes Management ◽  
Glycosylated Hemoglobin ◽  
Intervention Group ◽  
Dependent Diabetes Mellitus ◽  
Control Group ◽  
Standard Protocol ◽  
Weight Changes ◽  
Telephone Calls

This study tested the hypothesis that follow-up intervention (by telephone calls and home visit) affects compliance in patients with non-insulin-dependent diabetes mellitus (NIDDM). Sixty NIDDM patients were randomly assigned to two groups—a control group, which received the standard protocol (3-day educational program and a review session 1 month after the program); and an intervention group, which received the standard protocol as well as a series offour telephone calls and one home visit by a registered nurse over a 3-month period. Compliance to prescribed regimens was determined by analyzing three sets of data: changes in pre- to poststudy glycosylated hemoglobin (HbA1c) values; changes in pre- to poststudy weight; and frequency with which self-monitoring of blood glucose (SMBG) was practiced. Results showed that SMBG practice was significantly better for the intervention group. No significant differences were seen in poststudy HbA 1c values and weight changes between the two groups. Follow-up inter vention by telephone calls and home visit can enhance patient compliance to certain aspects of the prescribed diabetes management plan.

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