Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment

With health education, patients will have knowledge of the disease and may modify their attitudes to diabetes. Have a different behavior, will perform self-management of their health. Will adhere to physical activity, the better control of the disease and have quality of life. Empower the patient through the educational practices.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: The Education Health Program

Detailed Description

In this sense, from the perspective that the routine monitoring of users with type 2 diabetes should be performed at the primary health care, which has the structural axis the family health team, and that education is fundamental to the self-management of diabetes mellitus care, applying a evaluative research based on an educational program to check before and after clinical, anthropometric data and validated instruments can provide an effective means of control and prevention of disease.

The purpose of randomization is to compare the effects and values of the dependent variables ( knowledge about diabetes mellitus, psychological attitudes, adherence to practices related to physical activity and diet self-care, empowerment for self-care in diabetes mellitus and control of clinical indicators ) in the experimental group with the group control, which are associated with the independent variable ( educational program). For the experimental group an educational systematized process, to evaluate the scope for enhancing the educational process with emphasis on Diabetes empowerment to provide self-care, thereby improving disease control will be performed. Have the control group will maintain the traditional care through individual consultations and information about the disease, through leaflets that could assist in the educational process for self-management of care. All subjects in the experimental group and the control group will be questioned in the pre -test and post - test by related instruments: (1) knowledge of the diabetes mellitus, (2) attitudes toward the psychological aspects, (3) self-care (medication adherence, diet and physical activity), (4) empowerment for self-care in diabetes mellitus and (5) clinical indicators.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• users from 30 years of age diagnosed with type 2 diabetes mellitus,
• degree of education above the fourth grade of elementary education and
• ability to attend the education program.

Exclusion Criteria:

• users with reading disability and
• chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The Education Health Program; Intervention forth knowledge and attitudes necessary for self-care

Behavioral: The Education Health Program; The operation of the educational program for the group under intervention will consist of groups operating with the triad of diabetes mellitus (pathophysiology of the disease, physical activity and diet), to be held in five times (cycles) approach, an interval of three months being held between them . In each session, participants will be the same (under multidisciplinary team intervention), the content will also be the same, however, using different educational strategies. During the intervals between cycles these users will be monitored by phone by equity and / or nursing students of the Federal University of São João Del Rei properly trained to do so. The educational program will be developed in five times (T0, T3, T6, T9, T12) and with an interval of three months. At every moment the educational process will be conducted with three consecutive meetings with one week interval. In summary, 15 educational sessions with the experimental group will be held.; Other Names: Provide knowledge;; Attitudes;; and skills to care self-management and empowerment of diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated hemoglobin level before and after intervention	The intervention groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of knowledge about diabetes mellitus	The intervention and control groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention
diabetes mellitus empowerment for self-care	The intervention and control groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention
tests such as cholesterol	The intervention and control groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention
tests such as fasting glucose	The intervention and control groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention
body mass index	The intervention and control groups will be followed for 1 year. During this period glycated hemoglobins in time 0,3,6 and 12 months will be harvested.	1 year after start of the intervention

Other Outcome Measures

Outcome Measure	Time Frame
Loss of participants in the intervention by forfeit	1 year after start of the intervention

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Director: Heloisa Carvalho Torres, posdoctor, Federal University of Minas Gerais; Principal Investigator: Daniel Nogueira Cortez, master, Federal University of Minas Gerais

Publications and helpful links

General Publications

• Cortez DN, Macedo MM, Souza DA, Dos Santos JC, Afonso GS, Reis IA, Torres HC. Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial. BMC Public Health. 2017 Jan 6;17(1):41. doi: 10.1186/s12889-016-3937-5.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Estimate): May 7, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Prevention; Health Education; Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CAAE 22372013.2.000.5149