Type 2 Diabetes MellitusEarly Phase 1NCT02132338
Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
A Early Phase 1 study testing The Education Health Program in people with Type 2 Diabetes Mellitus, run by Federal University of Minas Gerais at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- The Education Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Nov 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- users with reading disability and
- chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- The Education Health Program
- Keywords
- Type 2 Diabetes Mellitus, Prevention, Health Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Education Health ProgramBehavioural
Also called Provide knowledge;, Attitudes;, and skills to care self-management and empowerment of diabetes mellitus.
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.
| Study group | Role | What they receive |
|---|---|---|
| The Education Health Program | Experimental | Intervention forth knowledge and attitudes necessary for self-care Receives: Behavioral: The Education Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after start of the intervention
Secondary outcomes (5)
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.
Measured: 1 year after start of the intervention
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.
Measured: 1 year after start of the intervention
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.
Measured: 1 year after start of the intervention
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.
Measured: 1 year after start of the intervention
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.
Measured: 1 year after start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HELOISA DE CARVALHO TORRES, Federal University of Minas Gerais
- Investigators
- Heloisa Carvalho Torres, posdoctor, Study director, Federal University of Minas GeraisDaniel Nogueira Cortez, master, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132338
- Sponsor's protocol ID
- CAAE 22372013.2.000.5149
- Status last verified
- May 2014
- First submitted
- 22 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28061840
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Educational Program of Diabetes Mellitus: Focus on Empowerment
- ClinicalTrials.gov ID
- NCT02132338
- Acronym / sponsor ID
- CAAE 22372013.2.000.5149
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Prevention, Health Education
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Education Health Program | Experimental | Behavioral: The Education Health ProgramIntervention forth knowledge and attitudes necessary for self-care |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- users with reading disability and
- chronic complications (defined as kidney failure, blindness, amputation of limbs, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Education Health ProgramAlso: Provide knowledge;, Attitudes;, and skills to care self-management and empowerment of diabetes mellitus.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. | Behavioural | The Education Health Program |
Primary outcome
Glycated hemoglobin level before and after intervention
Time frame: 1 year after start of the 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.
5 secondary outcomes
level of knowledge about diabetes mellitus
Time frame: 1 year after start of the intervention
diabetes mellitus empowerment for self-care
Time frame: 1 year after start of the intervention
tests such as cholesterol
Time frame: 1 year after start of the intervention
tests such as fasting glucose
Time frame: 1 year after start of the intervention
body mass index
Time frame: 1 year after start of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Derived from this study: PubMed 28061840Cortez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heloisa Carvalho Torres, posdoctor study director
Federal University of Minas Gerais
Daniel Nogueira Cortez, master principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing The Education Health Program in people with Type 2 Diabetes Mellitus, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin level before and after intervention (time frame: 1 year after start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02132338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.