Type 2 Diabetes MellitusPhase 4NCT01316367
Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing PRECEDE HPE model and CHPE in people with Type 2 Diabetes Mellitus and Cardiovascular Risk Factor, run by Hospital Carlos III, Madrid at 1 site in Spain.
Trial summary
BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. Read more about this study
- Who is it for?
- Ages 31 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Risk Factor
- What is being tested?
- PRECEDE HPE model and CHPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 4
- 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 31 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose > 200 mg/dl or oral glucose of > 200 mg/dl at 2 h, twice, or plasma fasting glucose of > 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)
Who cannot join
- Gestational diabetes
- Patients involved in clinical trials
- Patients with life expectancy less than 1 year (according to clinical judgment)
- Patients who refused to participate
- Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.
METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.
Read the detailed description
Assignment to the Health Promotion Education (HPE) will be random, three centers will use conventional HPE (the control group) and the remaining five will use PRECEDE-type HPE. Eligible patients are selected from a list of DM2 patients by each professional using random sampling, until the predetermined sample size is attained.
Conventional HPE is defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, and was complemented by the criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults for 2004-2007
- Being tested
- PRECEDE HPE model, CHPE
- Keywords
- Health Promotion Education, Type 2 Diabetes Mellitus, Cardiovascular Risk Factors, Spain
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECEDE HPE modelBehavioural
The model considers the influence of the following three factors on health-related behavior:
- Predisposing: factors influencing the patient's motivation to undertake the behavior to be analyzed or encouraged.
- Facilitators: factors influencing the level of easiness or difficulty the patient and his/her family have in undertaking a given behavior.
- Reinforcing: factors arising after the patient has undertaken the behavior, and which reward or punish it.
CHPEBehavioural
The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Health Promotion Education (CHPE). | Active comparator | The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation. Receives: Behavioral: CHPE |
| PRECEDE HPE model | Experimental | Not described Receives: Behavioral: PRECEDE HPE model |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
Measured: Final (before 2 years follow-up)
Secondary outcomes (3)
Blood Pressure
Systolic and Diastolic Blood Pressure
Measured: Final (before 2 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Measured: Final (before 2 years of follow-up)
Body Mass Index (BMI)
Measured: Final (before 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startFeb 2003
- Primary completionFeb 2005
- Study completionMar 2005
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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Carlos III, Madrid
- Sponsor type
- University, hospital or other
- Investigators
- Miguel A Salinero, MD, Principal investigator, Hospital Carlos III, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316367
- Sponsor's protocol ID
- HCIII-0106
- Other IDs
- PI02-0567
- Status last verified
- Mar 2003
- First submitted
- 15 Mar 2011
- Last updated
- 16 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Salinero-Fort MA, Carrillo-de Santa Pau E, Arrieta-Blanco FJ, Abanades-Herranz JC, Martin-Madrazo C, Rodes-Soldevila B, de Burgos-Lunar C. Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus. BMC Public Health. 2011 Apr 28;11:267. doi: 10.1186/1471-2458-11-267.
PubMed 21524316
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01316367
- Acronym / sponsor ID
- HCIII-0106
- Keywords
- Health Promotion Education, Type 2 Diabetes Mellitus, Cardiovascular Risk Factors, Spain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospital Carlos III, MadridUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 16 Mar 2011 (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.
BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.
METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.
Detailed description
Assignment to the Health Promotion Education (HPE) will be random, three centers will use conventional HPE (the control group) and the remaining five will use PRECEDE-type HPE. Eligible patients are selected from a list of DM2 patients by each professional using random sampling, until the predetermined sample size is attained.
Conventional HPE is defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, and was complemented by the criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults for 2004-2007
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Health Promotion Education (CHPE). | Active comparator | Behavioral: CHPEThe CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation. |
| PRECEDE HPE model | Experimental | Behavioral: PRECEDE HPE model |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose > 200 mg/dl or oral glucose of > 200 mg/dl at 2 h, twice, or plasma fasting glucose of > 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)
Key exclusion criteria (5 listed)
- Gestational diabetes
- Patients involved in clinical trials
- Patients with life expectancy less than 1 year (according to clinical judgment)
- Patients who refused to participate
- Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.
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 |
|---|---|---|
| PRECEDE HPE modelThe model considers the influence of the following three factors on health-related behavior: * Predisposing: factors influencing the patient's motivation to undertake the behavior to be analyzed or encouraged. * Facilitators: factors influencing the level of easiness or difficulty the patient and his/her family have in undertaking a given behavior. * Reinforcing: factors arising after the patient has undertaken the behavior, and which reward or punish it. | Behavioural | PRECEDE HPE model |
| CHPEThe CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation. | Behavioural | Conventional Health Promotion Education (CHPE). |
Primary outcome
HbA1c level
Time frame: Final (before 2 years follow-up)
3 secondary outcomes
Blood Pressure
Time frame: Final (before 2 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Time frame: Final (before 2 years of follow-up)
Body Mass Index (BMI)
Time frame: Final (before 2 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Derived from this study: PubMed 21524316Salinero-Fort MA, Carrillo-de Santa Pau E, Arrieta-Blanco FJ, Abanades-Herranz JC, Martin-Madrazo C, Rodes-Soldevila B, de Burgos-Lunar C. Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus. BMC Public Health. 2011 Apr 28;11:267. doi: 10.1186/1471-2458-11-267.
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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.
Miguel A Salinero, MD principal investigator
Hospital Carlos III, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRECEDE HPE model and CHPE in people with Type 2 Diabetes Mellitus and Cardiovascular Risk Factor, run by Hospital Carlos III, Madrid at 1 site in Spain.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 16 Mar 2011. 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 Spain. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c level (time frame: Final (before 2 years follow-up)). 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 NCT01316367, 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 16 Mar 2011.