Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALWorkshop
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.
BEHAVIORALUsual Care
Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated hemoglobin from baseline at 12 months | 12 months | Variation of glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin equal or less than 8,0 | 12 months | Number of patients reaching glycated hemoglobin equal or less than 8,0 |
| 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 6 months | 6 months | Change in SDSCA score 6 months after baseline |
| 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 Diabetes Quality of Life Questionnaire from baseline at 12 months | 12 months | Diabetes Quality of Life Questionnaire |
Countries
Brazil
Outcome results
None listed