NCT01282190

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 18, 2015

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

January 21, 2011

Last Update Submit

August 17, 2015

Conditions

Keywords

dyslipidemia, motivational interview, prevention

Outcome Measures

Primary Outcomes (1)

  • lipid levels

    12 months

Secondary Outcomes (1)

  • cardiovascular risk

    12 months

Study Arms (1)

Motivational interview

EXPERIMENTAL
Behavioral: Motivational interview

Interventions

Motivational interview

Motivational interview

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People diagnosed with dyslipidemia
  • To sign informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Medicine Teaching Unit and Community

Córdoba, Córdoba, 14011, Spain

Location

Related Publications (3)

  • 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.

  • Perula 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.

  • Perula 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.

Related Links

MeSH Terms

Conditions

Dyslipidemias

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 24, 2011

Study Start

June 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 18, 2015

Record last verified: 2015-08

Locations