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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02132338
• Other study ID #: CAAE 22372013.2.000.5149
• Status: Enrolling by invitation
• Phase: Phase 0
• First received: April 22, 2014
• Last updated: May 5, 2014
• Start date: June 2014
• Est. completion date: November 2017

Study information

• Verified date: May 2014
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Plataforma Brasil
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 191
• Est. completion date: November 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Loss of participants in the intervention by forfeit		1 year after start of the intervention	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No