Clinical trial NCT02132338: Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
Official title: Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Prevention
Health Education
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 191
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.).

Primary outcomes:
measure: Glycated hemoglobin level before and after intervention
timeFrame: 1 year after start of the intervention
Secondary outcomes:
measure: level of knowledge about diabetes mellitus
timeFrame: 1 year after start of the intervention
measure: diabetes mellitus empowerment for self-care
timeFrame: 1 year after start of the intervention
measure: tests such as cholesterol
timeFrame: 1 year after start of the intervention
measure: tests such as fasting glucose
timeFrame: 1 year after start of the intervention
measure: body mass index
timeFrame: 1 year after start of the intervention
Other outcomes:
measure: Loss of participants in the intervention by forfeit
timeFrame: 1 year after start of the intervention
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Heloisa Carvalho Torres, posdoctor
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Daniel Nogueira Cortez, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.