Effectiveness of Motivational Interview in Patients With... | NCT01282190

Studies
Effectiveness of Motivational Interview in Patients With Dyslipidemia

NCT01282190

Sponsor

Hospital Universitario Reina Sofia de Cordoba

Status

Completed

Last Update Posted

Aug 18, 2015Estimated

Enrollment

207Actual

Phase

Not Applicable

Conditions

Patients With Dyslipidemia

Interventions

Motivational interview

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 21, 2011

First Submission Date that Met QC Criteria

Jan 21, 2011

First Posted Date

Jan 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2015

Last Update Posted Date

Aug 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luis A Perula, Dr, Hospital Universitario Reina Sofia de CordobaPrincipal Investigator

Lead Sponsor

Hospital Universitario Reina Sofia de CordobaOTHER_GOV

Collaborators

Name	Class
Spanish Society of Family and Community Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the effectiveness of motivational interviewing to improve lipid control and cardiovascular risk in patients with dyslipidemia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Motivational interview	Experimental		Behavioral: Motivational interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational interview	Behavioral	Motivational interview	Motivational interview

Measure	Description	Time Frame
lipid levels		12 months

Measure	Description	Time Frame
cardiovascular risk		12 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Medicine Teaching Unit and Community		Córdoba	Córdoba	14011	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26498221	Derived	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.
23173902

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities