Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
The Education Health Program
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Prevention, Health Education
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.).
Sites / Locations
- Federal University of Minas Gerais
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Education Health Program
Arm Description
Intervention forth knowledge and attitudes necessary for self-care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02132338
First Posted
April 22, 2014
Last Updated
May 5, 2014
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02132338
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Prevention, Health Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Education Health Program
Arm Type
Experimental
Arm Description
Intervention forth knowledge and attitudes necessary for self-care
Intervention Type
Behavioral
Intervention Name(s)
The Education Health Program
Other Intervention Name(s)
Provide knowledge;, Attitudes;, and skills to care self-management and empowerment of diabetes mellitus.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycated hemoglobin level before and after intervention
Description
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.
Time Frame
1 year after start of the intervention
Secondary Outcome Measure Information:
Title
level of knowledge about diabetes mellitus
Description
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.
Time Frame
1 year after start of the intervention
Title
diabetes mellitus empowerment for self-care
Description
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.
Time Frame
1 year after start of the intervention
Title
tests such as cholesterol
Description
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.
Time Frame
1 year after start of the intervention
Title
tests such as fasting glucose
Description
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.
Time Frame
1 year after start of the intervention
Title
body mass index
Description
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.
Time Frame
1 year after start of the intervention
Other Pre-specified Outcome Measures:
Title
Loss of participants in the intervention by forfeit
Time Frame
1 year after start of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heloisa Carvalho Torres, posdoctor
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Nogueira Cortez, master
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28061840
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
We'll reach out to this number within 24 hrs