Model-driven diabetes care: study protocol for a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Skrovseth SO
PROVIDER: S-EPMC3655925 | biostudies-literature | 2013 May
REPOSITORIES: biostudies-literature
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Model-driven diabetes care: study protocol for a randomized controlled trial.
Skrøvseth Stein Olav SO Årsand Eirik E Godtliebsen Fred F Joakimsen Ragnar M RM
Trials 20130514
<h4>Background</h4>People with type 1 diabetes who use electronic self-help tools register a large amount of information about their disease on their participating devices; however, this information is rarely utilized beyond the immediate investigation. We have developed a diabetes diary for mobile phones and a statistics-based feedback module, which we have named Diastat, to give data-driven feedback to the patient based on their own data.<h4>Method</h4>In this study, up to 40 participants will ...[more]
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Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.
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Project description:BACKGROUND:Diabetes is a common disease with self-management a key aspect of care. Large prospective trials have shown that maintaining glycated hemoglobin less than 7% greatly reduces complications but translating this level of control into everyday clinical practice can be difficult. Intensive improvement programs are successful in attaining control in patients with type 2 diabetes, however, many patients experience glycemic relapse once returned to routine care. This early relapse is, in part, due to decreased adherence in self-management behaviors. OBJECTIVE:This paper describes the design of the Glycemic Relapse Prevention study. The purpose of this study is to determine the optimal frequency of maintenance intervention needed to prevent glycemic relapse. The primary endpoint is glycemic relapse, which is defined as glycated hemoglobin greater than 8% and an increase of 1% from baseline. METHODS:The intervention consists of telephonic contact by a nurse practitioner with a referral to a dietitian if indicated. This intervention was designed to provide early identification of self-care problems, understanding the rationale behind the self-care lapse and problem solve to find a negotiated solution. A total of 164 patients were randomized to routine care (least intensive), routine care with phone contact every three months (moderate intensity) or routine care with phone contact every month (most intensive). CONCLUSION:The baseline patient characteristics are similar across the treatment arms. Intervention fidelity analysis showed excellent reproducibility. This study will provide insight into the important but poorly understood area of glycemic relapse prevention.
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Project description:BackgroundType 1 diabetes is a disease with complex therapeutic recommendations that require day-to-day lifestyle changes. Motivational Interviewing is a communication tool that has proved effective in changing behaviors in people with addictions, obesity and type 2 diabetes. Our objective is to evaluate the effects of a Motivational Interviewing intervention in people with type 1 diabetes.MethodsSixty-six patients with type 1 diabetes and hemoglobin A1c >= 8% have been included and randomly assigned (computer-generated sequence, sealed envelopes, ratio 1:1) either to the intervention or to the control group. In the intervention group, appointments every 4 months with the endocrinologist include Motivational Interviewing; in the control group, the appointments proceed as usual. Patients will be followed for 16 months. The primary outcome will be self-care behaviors, assessed by a validated questionnaire, the Diabetes Self-Care Inventory-Revised Version. Secondary outcomes include: HbA1c, motivation for self-care, self-efficacy, health-related quality of life, satisfaction with professional-patient relationship, and fulfillment of patients' own objectives. The practitioners receive training in Motivational Interviewing in order to help them promote adherence to self-care, encourage patient motivation and improve the doctor-patient relationship. The Motivational Interviewing intervention will be evaluated by two psychologists, blinded to the assigned treatment, through video recordings of the sessions and the administration of a purpose-built questionnaire, the EVEM 2.0 scale.DiscussionThere is evidence that MI can improve self-care in type 2 diabetes. In this study, we aim to evaluate the effect of MI on self-care and HbA1c in people with type 1 diabetes.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03906786, identifier NCT03906786.
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Project description:BACKGROUND: A new model of complex diabetes care is provided by a multidisciplinary team which incorporates general practitioner (GP) Clinical Fellows supported by an Endocrinologist and diabetes educator within a community-based general practice setting. This study evaluates the health and clinical benefits of the new model of care, assesses the acceptability of the model to patients, GPs and other health professionals, and examines the cost-effectiveness of the model. METHODS/DESIGN: The study is an open, non-inferiority randomised controlled trial with data collected at baseline, 6 and 12 months. Participants are identified from new patients on hospital-based diabetes outpatient clinic waiting lists and new GP referrals. Eligible consenting patients are randomised to either a community practice site (intervention) or a hospital site (usual care). In the intervention model, medical care is led by a GP Clinical Fellow in partnership with an Endocrinologist. Quantitative measures include clinical indicators with HbA1c as the primary outcome; patient-reported outcomes include health-related quality of life, mental health and satisfaction with care. Qualitative methods will be used to explore the perspectives and experiences of patients and providers regarding the new model of care. An economic evaluation will also be undertaken. DISCUSSION: This model of care seeks to improve the quality and safety of healthcare at the interface between the hospital and primary care sectors for patients with complex diabetes. The study will provide empirical evidence about the impact of the model of care on health outcomes, patient and clinician satisfaction, as well as any economic impacts. TRIAL REGISTRATION: Clinical Trials Registry Number: ACTRN12612000380897.
| S-EPMC3831821 | biostudies-other
Project description:BackgroundWorld-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.Methods/designThis two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orControl groupStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.DiscussionForty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].
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Project description:BackgroundThe prevalence of hypertension is high and increasing in China in recent years. The treatment and control of hypertension calls for long-term management beyond hospital, which is hard to implement in traditional care settings. Integrated care combined with information technology can promote high-quality healthcare services across the life-course. However, few studies have applied a customized integrated care model in community-based hypertension management in China, catering to the emerging "three-manager" mode. This study aims to identify the effectiveness of a pathway-driven eHealth-based integrated model that implemented as a full-featured telehealth system to facilitate standardized management of hypertension in China.MethodsThe trial has been designed as a 1-year, non-blinded superiority trial with two parallel groups. A total of 402 hypertensive patients who meet the eligibility criteria will be recruited and randomized with a 1:1 allocation. All the participants will receive a mobile device for self-management, which is a part of our telehealth system. Participants in the control group will only use the device for BP measurement and receive regular follow-ups from care providers according to the guidelines. Participants in the intervention group will gain full access to the system and receive intervention based on the proposed model (a well-designed coordinated care pathway consisting of 9 tasks). Outcomes will be measured mainly on three occasions (at inclusion, at 6 months, and at 12 months). The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes include changes in diastolic blood pressure, biochemical indexes related to hypertension, lifestyles, self-management adherence, and hypertension awareness, as well as work efficiency of care providers.DiscussionThis study aims to investigate whether a pathway-driven eHealth-based integrated care model based on the "three-manager" mode will improve hypertension control in China. Success of the model would help improve the quality of present community-based management procedures and benefit more patients with uncontrolled hypertension.Trial registrationChinese Clinical Trial Registry ChiCTR1900027645 . Registered on November 22, 2019.
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Project description:BackgroundPoint-of-care ultrasound (POCUS) is a tool in increasing use, but there is still a lack of basics for its routine use and evidence of its impact in intensive care.ObjectiveTo measure the impact of POCUS on resource utilization, diagnostic accuracy, and clinical management in medical-surgical intensive care units (ICUs).MethodsProspective, controlled study, in two polyvalent ICUs. The patients were randomly assigned to POCUS or control group.InterventionsPOCUS patients received systematic ultrasound examination of optic nerve, lung/pleura, heart, abdomen, and venous system, performed at the bedside by trained intensivists. Control patients were treated by critical care specialists who do not perform ultrasound in their clinical practice.ResultsWe included 80 patients, 40 per group. There were no significant differences in age, sex, APACHE II score, or admission diagnosis. POCUS group used fewer resources per patient in the first 5 days of hospitalization: chest radiography (2.6 ± 2.0 vs 4.1 ± 3.5, P = 0.01), additional ultrasound evaluations performed by a radiology specialist (0.6 ± 0.7 vs 1.1 ± 0.7, P = 0.002), and computed tomography studies (0.5 ± 0.6 vs 0.9 ± 0.7, P = 0.007). Time to perform any requested ultrasound evaluation after ICU admission was 2.1 ± 1.6 h versus 7.7 ± 6.7 h (P = 0.001). Systematic ultrasound evaluation led to better characterization of ICU admission diagnosis in 14 (35%) patients and change in clinical management in 24 (60%). POCUS group had lower fluid balance at 48 and 96 h after admission (P = 0.01) and spent less time mechanically ventilated (5.1 ± 5.7 days vs 8.8 ± 9.4, P = 0.03).ConclusionsSystematic application of POCUS may decrease utilization of conventional diagnostic imaging resources and time of mechanical ventilation, and facilitate meticulous intravenous fluid administration in critically ill patients during the first week of stay in the ICU. Trial registration ClinicalTrials.gov Identifier: NCT03608202.
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Project description:BackgroundLaboratory services have a central role in supporting screening, diagnosis, and management of patients. The increase in chronic disease management in primary care for conditions such as diabetes mellitus requires regular monitoring of patients' biochemical parameters. This process offers a route for improving the quality of care that patients receive by using test results as a vehicle for delivering educational messages as well as the test result itself.AimTo develop and evaluate the effectiveness of a quality improvement initiative to improve the care of patients with diabetes using test report reminders.DesignA programme of four cluster randomised controlled trials within one population of general practices.ParticipantsGeneral practices in Newcastle-upon-Tyne, UK.InterventionBrief educational messages added to paper and electronic general practice laboratory test reports introduced over two phases. Phase One messages, attached to Haemoglobin A1c (HbA1c) reports, targeted glycaemic and cholesterol control. Phase Two messages, attached to albumin:creatinine ratio (ACR) reports, targeted blood pressure (BP) control and foot inspection.OutcomesGeneral practice mean levels of HbA1c and cholesterol (Phase One) and diastolic and systolic BP and proportions of patients having undergone foot inspections (Phase Two); number of tests requested.
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Project description:Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N?=?55) or usual care group (UC: N?=?55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients' and healthcare professionals' satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.ClinicalTrials.gov registration: NCT02511093 . Retrospectively registered on 28 July 2015.
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