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

NCT ID: NCT02132338

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-11-30

Brief 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.

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The Education Health Program

Intervention forth knowledge and attitudes necessary for self-care

Group Type: EXPERIMENTAL

The Education Health Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Provide knowledge; Attitudes; and skills to care self-management and empowerment of diabetes mellitus.

Eligibility Criteria

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.).

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

HELOISA DE CARVALHO TORRES

Postdoctoral

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heloisa Carvalho Torres, posdoctor

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Daniel Nogueira Cortez, master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28061840 (View on PubMed)

Other Identifiers

CAAE 22372013.2.000.5149

Identifier Type: -

Identifier Source: org_study_id