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

NCT03074383 | Completed

• 1 other identifier: 16-0646
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in glycated hemoglobin from baseline at 12 months

  Variation of glycated hemoglobin

  12 months

Secondary Outcomes (7)

• Change in glycated hemoglobin from baseline at 6 months

  6 months

• Variation of Diabetes Quality of Life Questionnaire from baseline at 6 months

  6 months

• Variation of Diabetes Quality of Life Questionnaire from baseline at 12 months

  12 months

• Glycated hemoglobin equal or less than 8,0

  12 months

• Glycated hemoglobin equal or less than 7,5

  12 months

Study Arms (2)

Workshop

EXPERIMENTAL

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.

Behavioral: Workshop

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

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.

Also known as: Self-Care Multidisciplinary Workshop for Diabetes

Workshop

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with previous diagnosis of type 2 diabetes, HbA1c greater than 7.5% and age greater than 18 years

You may not qualify if:

• Types of diabetes other than type 2 diabetes; neurological, psychiatric or cognitive impairment that prevents proper understanding and participation in the workshop

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Beatriz DAgord Schaan, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 8, 2017
• Study Start: March 20, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 1, 2019
• Last Updated: September 28, 2020

Record last verified: 2020-09

Locations

BR (1)