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Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial.

ABSTRACT: to compare the adherence and empowerment of patients with type 2 diabetes mellitus for self-care practices and glycemic control in group education strategies and home visits.Clinical trial with ten randomized clusters, performed with 238 patients with type 2 diabetes mellitus distributed in group education, home visit, and control group. Socio-demographic data, glycated hemoglobin and those obtained from the self-care and empowerment questionnaires were collected. Statistical analysis was performed separately by educational strategy.the mean age of the patients was 57.8 years old (SD = 9.4 years old), with a predominantly female participation (66.4%). Both strategies presented similar results regarding adherence to self-care practices and patient empowerment. There was also a reduction in glycated hemoglobin levels; however, only in the education group, the difference presented statistical significance (p <0.001).the strategies were effective; however, group education presented better glycemic control results in relation to the home visit. International registry: NCT02132338 and national: RBR-92j38t in the clinical trials registry.

SUBMITTER: Santos JCD

PROVIDER: S-EPMC5738960 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial.

Santos Jéssica Caroline Dos JCD Cortez Daniel Nogueira DN Macedo Maísa Mara Lopes MML Reis Edna Afonso EA Reis Ilka Afonso IA Torres Heloísa Carvalho HC

Revista latino-americana de enfermagem 20171221

<h4>Objective</h4>to compare the adherence and empowerment of patients with type 2 diabetes mellitus for self-care practices and glycemic control in group education strategies and home visits.<h4>Method</h4>Clinical trial with ten randomized clusters, performed with 238 patients with type 2 diabetes mellitus distributed in group education, home visit, and control group. Socio-demographic data, glycated hemoglobin and those obtained from the self-care and empowerment questionnaires were collected ...[more]

PMID: 29267547

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Project description:Importance:Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity. Objective:To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss. Design, Setting, and Participants:This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention. Interventions:Participants randomized to the GMV group (n?=?136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n?=?127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits). Main Outcomes and Measures:Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions. Results:Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P?=?.44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P?<?.001) and greater weight loss (mean difference, -3.7 kg; 95% CI, -5.5 to -1.9 kg; P?<?.001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P?<?.001) during the 48-week period. Conclusions and Relevance:In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes. Trial Registration:ClinicalTrials.gov identifier: NCT01973972.

Project description:ObjectivesThe effectiveness and costs associated with addition of pharmacist-led group medical visits to standard care for patients with Type-2 Diabetes Mellitus (T2DM) is unknown.MethodsRandomized-controlled-trial in three US Veteran Health Administration (VHA) Hospitals, where 250 patients with T2DM, HbA1c >7% and either hypertension, active smoking or hyperlipidemia were randomized to either (1) addition of pharmacist-led group-medical-visits or (2) standard care alone for 13 months. Group (4-6 patients) visits consisted of 2-hour, education and comprehensive medication management sessions once weekly for 4 weeks, followed by quarterly visits. Change from baseline in cardiovascular risk estimated by the UKPDS-risk-score, health-related quality-of-life (SF36v) and institutional healthcare costs were compared between study arms.ResultsAfter 13 months, both groups had similar and significant improvements from baseline in UKPDS-risk-score (-0.02 ±0.09 and -0.04 ±0.09, group visit and standard care respectively, adjusted p<0.05 for both); however, there was no significant difference between the study arms (adjusted p = 0.45). There were no significant differences on improvement from baseline in A1c, systolic-blood-pressure, and LDL as well as health-related quality-of-life measures between the study arms. Compared to 13 months prior, the increase in per-person outpatient expenditure from baseline was significantly lower in the group visit versus the standard care arm, both during the study intervention period and at 13-months after study interventions. The overall VHA healthcare costs/person were comparable between the study arms during the study period (p = 0.15); then decreased by 6% for the group visit but increased by 13% for the standard care arm 13 months post-study (p<0.01).ConclusionsAddition of pharmacist-led group medical visits in T2DM achieved similar improvements from baseline in cardiovascular risk factors than usual care, but with reduction in the healthcare costs in the group visit arm 13 months after completion compared to the steady rise in cost for the usual care arm.Trial registrationNCT00554671 ClinicalTrials.gov.

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Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial.

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Comparison of education group strategies and home visits in type 2 diabetes mellitus: clinical trial.

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