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INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

ABSTRACT: BACKGROUND:The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting. METHODS:This is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80?years with deficient glycaemic control (HbA1c > 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d'Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. DISCUSSION:This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care. TRIAL REGISTRATION:Clinicaltrials.gov . registration number. NCT02663245; January 25, 2016.

SUBMITTER: Mollo A

PROVIDER: S-EPMC6367799 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

Molló Àngels À Berenguera Anna A Rubinat Esther E Vlacho Bogdan B Mata Manel M Franch Josep J Bolíbar Bonaventura B Mauricio Dídac D

BMC family practice 20190207 1

<h4>Background</h4>The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment ...[more]

PMID: 30732583

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Project description:BACKGROUND:Self-efficacy has been shown to be positively correlated with self-care behaviour and glycaemic control among patients with type 2 diabetes mellitus. However, such evidence is lacking in the Malaysian primary care setting. The objectives of this study were to i) determine the levels of self-efficacy, self-care behaviour and glycaemic control among patients with type 2 diabetes mellitus in the Malaysian primary care setting ii) determine the relationship between self-efficacy, self-care behaviour and glycaemic control iii) determine the factors associated with glycaemic control. METHODS:This was a cross-sectional study involving patients with type 2 diabetes mellitus from two public primary care clinics in Malaysia. Self-efficacy and self-care behaviour levels were measured using previously translated and validated DMSES and SDSCA questionnaires in Malay versions, respectively. Glycaemic control was measured using HbA1c. RESULTS: A total of 340 patients with type 2 diabetes mellitus were recruited. The total mean (±SD) of self-efficacy and self-care behaviour scores were 7.33 (±2.25) and 3.76 (±1.87), respectively. A positive relationship was found between self-efficacy and self-care behaviour (r 0.538, P <?0.001). Higher self-efficacy score was shown to be correlated with lower HbA1c (r -?0.41, P <?0.001). Multiple linear regression analysis demonstrated that higher self-efficacy scores (b -?0.398; 95% CI: -0.024, -?0.014; P <?0.001), shorter duration of diabetes (b 0.177; 95% CI: 0.002, 0.007; P <?0.001) and smaller waist circumference (b 0.135; 95% CI: 0.006, 0.035; P =?0.006), were significantly associated with good glycaemic control. CONCLUSION:This study demonstrated that higher self-efficacy was correlated with improved self-care behaviour and better glycaemic control. Findings of this study suggest the importance of including routine use of self-efficacy measures in the management of type 2 diabetes mellitus in primary care.

Project description:IntroductionType 2 diabetes (T2D) is one of the most frequent comorbid medical conditions in pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual and infant. Achieving glycaemic control can be challenging for Medicaid-insured pregnant individuals who experience a high burden of unmet social needs. Multifaceted provider-patient-based approaches are needed to improve glycaemic control in this high-risk pregnant population. Mobile health (mHealth) applications (app), provider dashboards, continuous glucose monitoring (CGM) and addressing social needs have been independently associated with improved glycaemic control in non-pregnant individuals living with diabetes. The combined effect of these interventions on glycaemic control among pregnant individuals with T2D remains to be evaluated.Methods and analysisIn a two-arm randomised controlled trial, we will examine the combined effects of a multicomponent provider-patient intervention, including a patient mHealth app, provider dashboard, CGM, a community health worker to address non-medical health-related social needs and team-based care versus the current standard of diabetes and prenatal care. We will recruit 124 Medicaid-insured pregnant individuals living with T2D, who are ≤20 weeks of gestation with poor glycaemic control measured as a haemoglobin A1c ≥ 6.5% assessed within 12 weeks of trial randomisation or within 12 weeks of enrolling in prenatal care from an integrated diabetes and prenatal care programme at a tertiary care academic health system located in the Midwestern USA. We will measure how many individuals achieve the primary outcome of glycaemic control measured as an A1c<6.5% by the time of delivery, and secondarily, adverse pregnancy outcomes; patient-reported outcomes (eg, health and technology engagement, literacy and comprehension; provider-patient communication; diabetes self-efficacy; distress, knowledge and beliefs; social needs referrals and utilisation; medication adherence) and CGM measures of glycaemic control (in the intervention group).Ethics and disseminationThe Institutional Review Board at The Ohio State University approved this study (IRB: 2022H0399; date: 3 June 2023). We plan to submit manuscripts describing the user-designed methods and will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.Trial registration numberNCT05662462.

Project description:BackgroundThe purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes.MethodsWe screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months.ResultsWe randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference -2.57 mmol/mol; 95% CI -4.5, -0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (-0.55 mmol/mol; 95% CI -2.46, 1.35; p = 0.57), or INT vs CON arms (-2.14 mmol/mol; 95% CI -4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON -4.76 mmol/mol; 95% CI -7.75, -1.78 mmol/mol) than in older participants (-0.46 mmol/mol; 95% CI -2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (-6.01 mmol/mol; 95% CI -9.56, -2.46 age < 65 years old and -0.22 mmol/mol; 95% CI -2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (-7.0 mmol/mol; 95% CI -11.5, -2.5; p = 0.003).ConclusionThe NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months.Trial registrationISRCTN34805606 . Retrospectively registered 14.4.16.

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INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

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INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control.

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