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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Workshop; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Self-Care Multidisciplinary Workshop for Diabetes
Active Comparator: Usual Care; Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.	Behavioral: Usual Care; Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glycated hemoglobin from baseline at 12 months	Variation of glycated hemoglobin	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Beatriz DAgord Schaan, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 16-0646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No