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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03074383
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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 treatment satisfaction will be evaluated at the study entry, 6 and 12 months later.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Workshop Behavioral: Usual Care Not Applicable

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 treatment satisfaction will be evaluated at the study entry, 6 and 12 months later.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Change in glycated hemoglobin from baseline at 12 months [ Time Frame: 12 months ]
    Variation of glycated hemoglobin


Secondary Outcome Measures :
  1. Change in glycated hemoglobin from baseline at 6 months [ Time Frame: 6 months ]
    Variation of glycated hemoglobin

  2. Variation of Diabetes Treatment Satisfaction Questionnaire from baseline at 6 months [ Time Frame: 6 months ]
    Diabetes Treatment Satisfaction Questionnaire

  3. Variation of Diabetes Treatment Satisfaction Questionnaire from baseline at 12 months [ Time Frame: 12 months ]
    Diabetes Treatment Satisfaction Questionnaire

  4. Glycated hemoglobin equal or less than 8,0 [ Time Frame: 12 months ]
    Number of patients reaching glycated hemoglobin equal or less than 8,0

  5. Glycated hemoglobin equal or less than 7,5 [ Time Frame: 12 months ]
    Number of patients reaching glycated hemoglobin equal or less than 7,5

  6. Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 6 months [ Time Frame: 6 months ]
    Change in SDSCA score 6 months after baseline

  7. Variation of Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) from baseline at 12 months [ Time Frame: 12 months ]
    Change in SDSCA score 12 months after baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074383


Locations
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Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Study Director: Beatriz DAgord Schaan, PhD Hospital de Clinicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03074383    
Other Study ID Numbers: 16-0646
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases