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Effectiveness of Motivational Interview in Patients With Dyslipidemia (Dislip-EM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01282190
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : August 18, 2015
Sponsor:
Collaborator:
Spanish Society of Family and Community Medicine
Information provided by (Responsible Party):
Luis A Perula, Hospital Universitario Reina Sofia de Cordoba

Tracking Information
First Submitted Date  ICMJE January 21, 2011
First Posted Date  ICMJE January 24, 2011
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
lipid levels [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
cardiovascular risk [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Motivational Interview in Patients With Dyslipidemia
Official Title  ICMJE Effectiveness of Motivational Interview in Patients With Dyslipidemia Treated in Primary Care Consultations (Dislip-EM Study)
Brief Summary Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Patients With Dyslipidemia
Intervention  ICMJE Behavioral: Motivational interview
Motivational interview
Study Arms  ICMJE Experimental: Motivational interview
Intervention: Behavioral: Motivational interview
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2015)
207
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2011)
400
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • People diagnosed with dyslipidemia
  • To sign informed consent.

Exclusion Criteria:

  • 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.
  • Patients with hepatic or renal disorders .
  • Subjects heavy drinkers.
  • Patients with long standing sick leave (more than 6 months).
  • Pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01282190
Other Study ID Numbers  ICMJE PI-0100/2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
Study Sponsor  ICMJE Hospital Universitario Reina Sofia de Cordoba
Collaborators  ICMJE Spanish Society of Family and Community Medicine
Investigators  ICMJE Not Provided
PRS Account Hospital Universitario Reina Sofia de Cordoba
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP