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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Workshop; Behavioral: Usual Care

• Registration Number: NCT03074383
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Study Start: 2017-03-20
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Workshop	Workshop	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.
Usual Care	Usual Care	Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.

Primary Outcome Measures

Name	Time	Method
Change in glycated hemoglobin from baseline at 12 months	12 months	Variation of glycated hemoglobin

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil