Improvement of Care for Outpatients With Type 2 Diabetes Through Self-Care Multidisciplinary Workshop for Diabetes

Study Overview
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Brief Summary
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Ninety-six patients with diabetes will be randomly assigned to maintain standard treatment or participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists of individual meetings, with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. The workshop will be offered in 3 different modules with 2 to 4 weeks difference between them. The variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.

Detailed Description
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Ninety-six patients with type 2 diabetes from our Diabetes Outpatient Clinic will be randomly assigned to maintain standard treatment or participate in the Self-Care Multidisciplinary Workshop for Diabetes. The workshop consists of 15-minute individual meetings with each professional of a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator and social worker) in which education and self-care topics will be approached aiming at the formation of knowledge and skills necessary for patient self-care. The workshop will be offered in 3 different modules with 2 to 4 weeks difference between them. Patients will be followed for 12 months. The variation of glycated hemoglobin as well as aspects associated with self-care, adherence and quality of life will be evaluated at the study entry, 6 and 12 months later.

Official Title
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Improvement of Care for Outpatients With Type 2 Diabetes at the Porto Alegre Clinic Hospital Through Self-Care Multidisciplinary Workshop for Diabetes: a Randomized Controlled Trial

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Workshop
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7.5% and age greater than 18 years Exclusion Criteria: Types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Workshop<br>Self-Care Multidisciplinary Workshop for Diabetes consist in individual meetings with a multidisciplinary team (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) in which education and self-care topics will be approached. The workshop will be offered in 3 different modules with 2-4 weeks difference between them. | Behavioral: Workshop<br>* A 15-minute Individual meetings with each professional (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) of the multidisciplinary team in which diabetes education and self-care topics will be approached.<br>* Other names: Self-Care Multidisciplinary Workshop for Diabetes;|
| Active Comparator: Usual Care<br>Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material. | Behavioral: Usual Care<br>* Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated hemoglobin from baseline at 12 months | Variation of glycated hemoglobin | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated hemoglobin from baseline at 6 months | Variation of glycated hemoglobin | 6 months | 
| Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months | Diabetes Quality of Life Questionnaire | 6 months | 
| Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months | Diabetes Quality of Life Questionnaire | 12 months | 
| Glycated hemoglobin equal or less than 8,0 | Number of patients reaching glycated hemoglobin equal or less than 8,0 | 12 months | 
| Glycated hemoglobin equal or less than 7,5 | Number of patients reaching glycated hemoglobin equal or less than 7,5 | 12 months | 
| Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months | Change in SDSCA score 6 months after baseline | 6 months | 
| Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months | Change in SDSCA score 12 months after baseline | 12 months |