Text Size

Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01090999
First received: March 19, 2010
Last updated: January 19, 2011
Last verified: January 2011
History of Changes
  Purpose

OBJECTIVE: To determine whether a long-term maintenance program after respiratory rehabilitation, in contrast to the usual minimal maintenance therapy, improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.

MATERIAL AND METHODS: multi-center (4 hospitals) prospective randomized controlled study that will include 150 patients with moderate-severe COPD (age <75; BODE 4-10) with a 3 years follow-up. All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies:1.-an intensive maintenance program (GR1) 2.- a standard, minimal monitoring program (GR2). On the intensive maintenance program (GR1) the physiotherapist will call once a week as a reminder and the patient will attend the hospital once a week . A physiotherapist will supervise the weekly in-hospital exercise and he/she will check if the patient is properly undergoing the rehabilitation treatment.

OUTCOMES: 1.- Clinical: dyspnea (area of CRQ questionnaire), HRQL (CRQ, SF 36); Effort capacity (6minute Walking Test), BODE index; 2.- Economical: direct costs (programs); indirect costs (exacerbations, admissions); comparison of GR1 and GR2 costs; EXPECTED OUTCOMES: reduction of dyspnea, improvement of HRQL, effort capacity and BODE index, and reduction of health expenditures in GR1 compared to GR2.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Other: long-term maintenance respiratory rehabilitation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long - Term Respiratory Rehabilitation Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients: Study of Cost- Effectiveness.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 1.- Clinical: dyspnea (area of CRQ questionnaire), [ Time Frame: 1.5 YEARS ] [ Designated as safety issue: Yes ]
  • Effort capacity (6minute Walking Test), [ Time Frame: 1.5 Years ] [ Designated as safety issue: Yes ]
  • BODE index; [ Time Frame: 1.5 Years ] [ Designated as safety issue: Yes ]
  • Economical: direct costs (programs); [ Time Frame: 1.5 Years ] [ Designated as safety issue: Yes ]
  • indirect costs (exacerbations, admissions); [ Time Frame: 1.5 Years ] [ Designated as safety issue: Yes ]
  • comparison of GR1 and GR2 costs; [ Time Frame: 1.5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: October 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1

All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies.

The No Intervention group will undergo a standard, minimal monitoring program.

 Other: long-term maintenance respiratory rehabilitation program
To determine whether a long-term maintenance program after respiratory rehabilitation (group active comparator), in contrast to the usual minimal maintenance therapy (group no intervention), improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.
Active Comparator: 2

All patients will receive an initial in-hospital rehabilitation program which includes: Education, Physiotherapy, lower and upper extremities training and respiratory muscles training. Following completion of this program, patients will undergo concealed randomization to one of two maintenance strategies.

The active comparator group will undergo an intensive maintenance program after the initial in-hospital rehabilitation program.

 Other: long-term maintenance respiratory rehabilitation program
To determine whether a long-term maintenance program after respiratory rehabilitation (group active comparator), in contrast to the usual minimal maintenance therapy (group no intervention), improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.

  Eligibility

Ages Eligible for Study:   up to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD Patients
  • Less than 77 years
  • BODE index of 3-10 (BODE 3 when FEV1<50% v. Ref.).
  • clinically stable (at least one month)
  • Informed consent signed

Exclusion Criteria:

  • Bone or muscle disease that limits the exercise training.
  • Heart disease that disable physic exercise.
  • Bronchiectasis or other Respiratory diseases different than COPD.
  • Comorbidity that difficult o disable respiratory rehabilitation program carrying out.
  • Life expectation less than 2 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090999

Contacts
Contact: M Rosa Güell, Medical Doctor +034935575972 ext - MGuellR@santpau.cat
Contact: M Carme Puy, Physician +034935575972 ext - MPuyR@santpau.cat

Locations
Spain
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: M Rosa Güell, Medical Doctor     +034935575972 ext -     MGuellR@santpau.cat    
Contact: M Carme Puy, Physician     +034935575972 ext -     MPuyR@santpau.cat    
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Carme Puy Rion, Hospital del a Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01090999     History of Changes
Other Study ID Numbers: PR04/04/2007
Study First Received: March 19, 2010
Last Updated: January 19, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
COPD
Pulmonary Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013