NCT02132338

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
191

participants targeted

Target at P75+ for early_phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2014

Longer than P75 for early_phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

April 22, 2014

Last Update Submit

May 5, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusPreventionHealth Education

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • level of knowledge about diabetes mellitus

    1 year after start of the intervention

  • diabetes mellitus empowerment for self-care

    1 year after start of the intervention

  • tests such as cholesterol

    1 year after start of the intervention

  • tests such as fasting glucose

    1 year after start of the intervention

  • body mass index

    1 year after start of the intervention

Other Outcomes (1)

  • Loss of participants in the intervention by forfeit

    1 year after start of the intervention

Study Arms (1)

The Education Health Program

EXPERIMENTAL

Intervention forth knowledge and attitudes necessary for self-care

Behavioral: The Education Health Program

Interventions

The Education Health ProgramBEHAVIORAL

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.

Also known as: Provide knowledge;, Attitudes;, and skills to care self-management and empowerment of diabetes mellitus.
The Education Health Program

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 28061840DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Health Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Heloisa Carvalho Torres, posdoctor

    Federal University of Minas Gerais

    STUDY DIRECTOR

  • Daniel Nogueira Cortez, master

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral

Study Record Dates

First Submitted

April 22, 2014

First Posted

May 7, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

November 1, 2017

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

BR(1)