Patients With DyslipidemiaDislip-EMNCT01282190
Effectiveness of Motivational Interview in Patients With Dyslipidemia
A study testing Motivational interview in people with Patients With Dyslipidemia, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Dyslipidemia
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Mar 2015
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People diagnosed with dyslipidemia
- To sign informed consent.
Who cannot join
- Secondary hypercholesterolemia.
- Familial hypercholesterolemia.
- Deficiency syndromes family high density lipoprotein.
- Subjects with a history of cardiac or cerebrovascular events.
- Other chronic health problems such as diabetes or severe COPD.
- Subjects with current diagnosis of cancer.
Show all 10Show fewer
- Patients with hepatic or renal disorders .
- Subjects heavy drinkers.
- Patients with long standing sick leave (more than 6 months).
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Motivational Interview in Patients With Dyslipidemia Treated in Primary Care Consultations (Dislip-EM Study)
Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia.
- Conditions
- Patients With Dyslipidemia
- Being tested
- Motivational interview
- Keywords
- dyslipidemia, motivational interview, prevention
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
Motivational interview
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview | Experimental | Not described Receives: Behavioral: Motivational interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid levels
Measured: 12 months
Secondary outcomes (1)
cardiovascular risk
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With DyslipidemiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Collaborators
- Spanish Society of Family and Community Medicine
- Responsible party
- Principal investigator, Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282190
- Sponsor's protocol ID
- PI-0100/2008
- Acronym
- Dislip-EM
- Status last verified
- Aug 2015
- First submitted
- 21 Jan 2011
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boveda-Fontan J, Barragan-Brun N, Campinez-Navarro M, Perula-de Torres LA, Bosch-Fontcuberta JM, Martin-Alvarez R, Arbonies-Ortiz JC, Novo-Rodriguez JM, Criado-Larumbe M, Fernandez-Garcia JA, Martin-Rioboo E; Collaborative Group Estudio Dislip-EM. Effectiveness of motivational interviewing in patients with dyslipidemia: a randomized cluster trial. BMC Fam Pract. 2015 Oct 24;16:151. doi: 10.1186/s12875-015-0370-2.
PubMed 26498221Perula LA, Campinez M, Bosch JM, Barragan Brun N, Arbonies JC, Boveda Fontan J, Martin Alvarez R, Prados JA, Martin-Rioboo E, Massons J, Criado M, Fernandez JA, Parras JM, Ruiz-Moral R, Novo JM; collaborative Group Dislip-EM. Is the Scale for Measuring Motivational Interviewing Skills a valid and reliable instrument for measuring the primary care professionals motivational skills?: EVEM study protocol. BMC Fam Pract. 2012 Nov 22;13:112. doi: 10.1186/1471-2296-13-112.
PubMed 23173902Perula LA, Bosch JM, Boveda J, Campinez M, Barragan N, Arbonies JC, Prados JA, Martin E, Martin R, Massons J, Criado M, Ruiz R, Fernandez JA, Buitrago F, Olaya I, Perez M, Ruiz J. Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol. BMC Fam Pract. 2011 Nov 5;12:125. doi: 10.1186/1471-2296-12-125.
PubMed 22054017
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Motivational Interview in Patients With Dyslipidemia Treated in Primary Care Consultations (Dislip-EM Study)
- ClinicalTrials.gov ID
- NCT01282190
- Acronym / sponsor ID
- Dislip-EM / PI-0100/2008
- Conditions
- Patients With Dyslipidemia
- Keywords
- dyslipidemia, motivational interview, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Collaborators
- Spanish Society of Family and Community Medicine
- Study start
- Jun 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Jan 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.
Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Experimental | Behavioral: Motivational interview |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People diagnosed with dyslipidemia
- To sign informed consent.
Key exclusion criteria (10 listed)
- Secondary hypercholesterolemia.
- Familial hypercholesterolemia.
- Deficiency syndromes family high density lipoprotein.
- Subjects with a history of cardiac or cerebrovascular events.
- Other chronic health problems such as diabetes or severe COPD.
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 |
|---|---|---|
| Motivational interviewMotivational interview | Behavioural | Motivational interview |
Primary outcome
lipid levels
Time frame: 12 months
1 secondary outcome
cardiovascular risk
Time frame: 12 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 18 Aug 2015.
- Derived from this study: PubMed 26498221Boveda-Fontan J, Barragan-Brun N, Campinez-Navarro M, Perula-de Torres LA, Bosch-Fontcuberta JM, Martin-Alvarez R, Arbonies-Ortiz JC, Novo-Rodriguez JM, Criado-Larumbe M, Fernandez-Garcia JA, Martin-Rioboo E; Collaborative Group Estudio Dislip-EM. Effectiveness of motivational interviewing in patients with dyslipidemia: a randomized cluster trial. BMC Fam Pract. 2015 Oct 24;16:151. doi: 10.1186/s12875-015-0370-2.
- Derived from this study: PubMed 23173902Perula LA, Campinez M, Bosch JM, Barragan Brun N, Arbonies JC, Boveda Fontan J, Martin Alvarez R, Prados JA, Martin-Rioboo E, Massons J, Criado M, Fernandez JA, Parras JM, Ruiz-Moral R, Novo JM; collaborative Group Dislip-EM. Is the Scale for Measuring Motivational Interviewing Skills a valid and reliable instrument for measuring the primary care professionals motivational skills?: EVEM study protocol. BMC Fam Pract. 2012 Nov 22;13:112. doi: 10.1186/1471-2296-13-112.
- Derived from this study: PubMed 22054017Perula LA, Bosch JM, Boveda J, Campinez M, Barragan N, Arbonies JC, Prados JA, Martin E, Martin R, Massons J, Criado M, Ruiz R, Fernandez JA, Buitrago F, Olaya I, Perez M, Ruiz J. Effectiveness of Motivational Interviewing in improving lipid level in patients with dyslipidemia assisted by general practitioners: Dislip-EM study protocol. BMC Fam Pract. 2011 Nov 5;12:125. doi: 10.1186/1471-2296-12-125.
- protocol studyLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Patients With Dyslipidemia, run by Hospital Universitario Reina Sofia de Cordoba 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 18 Aug 2015. 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.
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?
lipid levels (time frame: 12 months). 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 NCT01282190, which also lists 3 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 18 Aug 2015.