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Completed

NCT Number: NCT03074383

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Workshop

Behavioral

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.

Other names: Self-Care Multidisciplinary Workshop for Diabetes

Usual Care

Behavioral

Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.

Primary outcomes

  1. Change in glycated hemoglobin from baseline at 12 months

    Time frame: 12 months

    Variation of glycated hemoglobin

Secondary outcomes

  1. Change in glycated hemoglobin from baseline at 6 months

    Time frame: 6 months

    Variation of glycated hemoglobin

  2. Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months

    Time frame: 6 months

    Diabetes Quality of Life Questionnaire

  3. Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months

    Time frame: 12 months

    Diabetes Quality of Life Questionnaire

  4. Glycated hemoglobin equal or less than 8,0

    Time frame: 12 months

    Number of patients reaching glycated hemoglobin equal or less than 8,0

  5. Glycated hemoglobin equal or less than 7,5

    Time frame: 12 months

    Number of patients reaching glycated hemoglobin equal or less than 7,5

  6. Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months

    Time frame: 6 months

    Change in SDSCA score 6 months after baseline

  7. Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months

    Time frame: 12 months

    Change in SDSCA score 12 months after baseline

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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