Prediabetic StatePhase 4DE-PLAN ENCT01365013
Evaluation of the Translation of the DE-PLAN Program for the Primary Prevention of Type 2 Diabetes in Routine Primary Care
A Phase 4 study testing DE-PLAN in people with Prediabetic State, run by Basque Health Service at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Prediabetic State
- What is being tested?
- DE-PLAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,113 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Jul 2015
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 70 years old
- high risk of developing type-II diabetes (Findrisc scale > 14 points)
Who cannot join
- Disorders of the cardiovascular system
- Transplant recipients
- Renal or hepatic failure
- Severe chronic obstructive pulmonary disease
- Severe mental disorders
- Chronic and acute severe infections
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- Metabolic uncontrolled disorders
- Restrictive pathology of muscles, bones and joints
- Complicated pregnancy
- Contact difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care
The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control centers.
Read the detailed description
Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza) in which such intervention is implemented, compared to usual care control centers.
DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14 primary care centers from Osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (FINDRISC scale> 14), identified by a screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-II diabetes.
ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the program. The attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to DE-PLANЄ intervention and of patients from control centers. The incremental cost-utility of DE-PLANЄ program will be also analysed.
- Conditions
- Prediabetic State
- Being tested
- DE-PLAN, Control group
- Keywords
- Lifestyle, Prediabetic State, Patient Education, Primary Health Care
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-PLANBehavioural
structured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year
Control groupBehavioural
Standard advice for lifestyle change
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: DE-PLAN |
| control group | Active comparator | Not described Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of healthy lifestyles
Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
Measured: 12 months
Incidence of Diabetes
Effectiveness of the program in the reduction of the Incidence of Diabetes
Measured: 24 months
Secondary outcomes (2)
Reach of the program
Percentage of eligible participants exposed to the program
Measured: 24 months
Implementation of the program
Extent in which the intervention components have been delivered as intended (intervention protocol)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Carmen Silvestre Busto, Basque Health Service
- Investigators
- Carmen Silvestre, Principal investigator, Basque Health ServiceAlvaro Sanchez, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365013
- Sponsor's protocol ID
- 2010111039
- Acronym
- DE-PLAN E
- Status last verified
- Jul 2016
- First submitted
- 1 Jun 2011
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.
PubMed 27206733Sanchez A, Silvestre C, Sauto R, Martinez C, Grandes G; PreDE research group. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial. BMC Fam Pract. 2012 Nov 16;13:109. doi: 10.1186/1471-2296-13-109.
PubMed 23158830
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Translation of a Type 2 Diabetes Primary Prevention Program in Routine Context of Primary Heath Care
- ClinicalTrials.gov ID
- NCT01365013
- Acronym / sponsor ID
- DE-PLAN E / 2010111039
- Conditions
- Prediabetic State
- Keywords
- Lifestyle, Prediabetic State, Patient Education, Primary Health Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,113 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Jun 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.
The purpose of this study is to evaluate the feasibility and effectiveness of the DE-PLAN Euskadi program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza-Basque Health Service) in which such intervention is implemented, compared to usual care control centers.
Detailed description
Objective: To evaluate the feasibility and effectiveness of the DE-PLANЄ program for the primary prevention of type-II diabetes in high-risk population seen in primary care centers (Osakidetza) in which such intervention is implemented, compared to usual care control centers.
DESIGN AND METHODS: A phase IV cluster randomized prospective clinical trial, conducted in 14 primary care centers from Osakidetza, which will be randomly assigned to intervention or control group, that will collect a sample of 2534 followed for two years, aged 45 to 70 years without diabetes but with high risk of developing it (FINDRISC scale> 14), identified by a screening system. Nurses in intervention centers (GI) will implement DEPLANЄ for 12 months, a structured educational intervention on healthy lifestyles (diet and physical activity), while patients of the control centers will receive standard care for the prevention and treatment of type-II diabetes.
ANALYSIS: The feasibility will be reported as the reach, adoption and implementation of the program. The attributable effectiveness of the program will be determined by comparing the changes in the incidence and risk of developing diabetes in healthy habits quality of life, observed in patients exposed to DE-PLANЄ intervention and of patients from control centers. The incremental cost-utility of DE-PLANЄ program will be also analysed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: DE-PLAN |
| control group | Active comparator | Behavioral: Control group |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 45 to 70 years old
- high risk of developing type-II diabetes (Findrisc scale > 14 points)
Key exclusion criteria (10 listed)
- Disorders of the cardiovascular system
- Transplant recipients
- Renal or hepatic failure
- Severe chronic obstructive pulmonary disease
- Severe mental disorders
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 |
|---|---|---|
| DE-PLANstructured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year | Behavioural | Lifestyle counseling |
| Control groupStandard advice for lifestyle change | Behavioural | control group |
Primary outcome
Adoption of healthy lifestyles
Time frame: 12 months
Change in the adoption of minimum recommended levels of physical activity and fruit and vegetable consumption
Incidence of Diabetes
Time frame: 24 months
Effectiveness of the program in the reduction of the Incidence of Diabetes
2 secondary outcomes
Reach of the program
Time frame: 24 months
Implementation of the program
Time frame: 24 months
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 29 Jul 2016.
- Derived from this study: PubMed 27206733Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.
- Derived from this study: PubMed 23158830Sanchez A, Silvestre C, Sauto R, Martinez C, Grandes G; PreDE research group. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial. BMC Fam Pract. 2012 Nov 16;13:109. doi: 10.1186/1471-2296-13-109.
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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.
Carmen Silvestre principal investigator
Basque Health Service
Alvaro Sanchez principal investigator
Basque Health Service
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 DE-PLAN in people with Prediabetic State, run by Basque Health Service 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 2 inclusion and 10 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 29 Jul 2016. 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?
Adoption of healthy lifestyles (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT01365013, which also lists 2 linked publications.
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 29 Jul 2016.