NCT01089842

Brief Summary

The purpose of this study is to evaluate the efficacy of motivational interviewing-based coaching to increase physical activity to achieve guidelines recommendations for cardiovascular disease prevention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 19, 2010

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

March 18, 2010

Last Update Submit

March 18, 2010

Conditions

Keywords

Secondary PreventionHealth PromotionBehavioral MedicineExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • Patients achieving recommended physical activity (>600 MET-minute/week)

    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)

    6 months

Secondary Outcomes (2)

  • Cost-efficacy of coaching

    6 months

  • Improvement on functional capacity

    6 months

Study Arms (2)

Health coaching

EXPERIMENTAL
Behavioral: Health coaching

Control

NO INTERVENTION
Other: Usual care

Interventions

Health coachingBEHAVIORAL

Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.

Health coaching

Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (\<600MET-min/week).

You may not qualify if:

  • Bundle branch block or pacemaker rhythm
  • Limitation or contraindication to moderate physical activity (fast walking)
  • Unstable clinical situation
  • Communication difficulties due to language or sensorial deficiencies.
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sabadell

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Joan R Guma

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

January 1, 2012

Last Updated

March 19, 2010

Record last verified: 2010-02

Locations