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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074383
• Other study ID #: 16-0646
• Status: Completed
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: September 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Workshop
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.
• Usual Care
Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycated hemoglobin from baseline at 12 months	Variation of glycated hemoglobin	12 months
Secondary	Change in glycated hemoglobin from baseline at 6 months	Variation of glycated hemoglobin	6 months
Secondary	Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months	Diabetes Quality of Life Questionnaire	6 months
Secondary	Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months	Diabetes Quality of Life Questionnaire	12 months
Secondary	Glycated hemoglobin equal or less than 8,0	Number of patients reaching glycated hemoglobin equal or less than 8,0	12 months
Secondary	Glycated hemoglobin equal or less than 7,5	Number of patients reaching glycated hemoglobin equal or less than 7,5	12 months
Secondary	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
Secondary	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