Clinical trial NCT03074383: Improvement of Care for Outpatients With Type 2 Diabetes Through Self-Care Multidisciplinary Workshop for Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in glycated hemoglobin from baseline at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in glycated hemoglobin from baseline at 6 months
timeFrame: 6 months
measure: Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months
timeFrame: 6 months
measure: Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months
timeFrame: 12 months
measure: Glycated hemoglobin equal or less than 8,0
timeFrame: 12 months
measure: Glycated hemoglobin equal or less than 7,5
timeFrame: 12 months
measure: Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months
timeFrame: 6 months
measure: Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Beatriz DAgord Schaan, PhD
role: STUDY_DIRECTOR
References: