NCT01567189

Brief Summary

The hypothesis is that home based clinical rehabilitation (CR) is less expensive than hospital based CR with similar clinical effectiveness. The investigators will compare the results of two forms of CR on

  1. 1.direct and indirect healthcare costs
  2. 2.effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate
  3. 3.cost/effectiveness analysis

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
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

February 22, 2012

Last Update Submit

March 28, 2012

Conditions

Coronary Heart Disease

Keywords

Exercise therapycost effectivenesscardiac rehabilitationhome-based exercise

Outcome Measures

Primary Outcomes (2)

  • Morbidity

    Readmissions, percutaneous or surgical revascularization

    1 year

  • Cost

    1. Direct costs 1. direct healthcare costs: hospital admissions for cardiovascular causes, percutaneous or surgical revascularization, medical and nursing consultation, physical training sessions, medical explorations including the analytic explorations, medication consumption, emergency department visits, depreciation of equipment used. 2. Direct costs other than health: Transfer the patient for his attention, passenger costs if necessary. 2. Indirect costs: working days lost during program participation (2 months, family overloads caused by participation in the program (2 months).

    1 year

Secondary Outcomes (5)

  • Control of risk factors

    1 year

  • Functional capacity

    1 year

  • Quality of Life

    1 year

  • Satisfaction

    1 year

  • Mortality

    1 year

Study Arms (2)

Hospital cardiac rehabilitation

EXPERIMENTAL

The patients will perform physical training sessions in the hospital

Behavioral: Cardiac rehabilitation

Home cardiac rehabilitation

ACTIVE COMPARATOR

The patients will perform physical training sessions at home

Behavioral: Cardiac rehabilitation

Interventions

Cardiac rehabilitationBEHAVIORAL

* Training sessions: 8 weeks of supervised physical training sessions. Stress intensity will be calculated from the peak heart rate reached during stress test: 60-70% during the first month and 70-85% during the second one. Patients will be advised to do at least 1 hour of outdoor exercise with the same intensity on the days when they do not attend hospital. * Health education sessions and relaxation sessions: one per week. * Smoking and diet checking: as recommended by doctor.

Hospital cardiac rehabilitation

Eligibility Criteria

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

You may qualify if:

  • patients referred to cardiac rehabilitation program in the first twelve weeks after an acute coronary syndrome (myocardial infarction or unstable angina) or after percutaneous or surgical revascularization
  • who have no contraindication to participate in the program

You may not qualify if:

  • contraindication to participate in the program
  • high-risk criteria for home cardiac rehabilitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Fernando Aros Borau

CONTACT

+34 945 007000LUISFDO.AROSBORAU@osakidetza.net

Study Design

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

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 30, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

ES(1)