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Clinical Trials/NCT01520376
NCT01520376
Completed
N/A

A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Counseling Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation

Nestor Soler Porcar, MD, PhD1 site in 1 country169 target enrollmentOctober 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Nestor Soler Porcar, MD, PhD
Enrollment
169
Locations
1
Primary Endpoint
Efficacy of the intervention
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
April 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nestor Soler Porcar, MD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Nestor Soler Porcar, MD, PhD

Especialista Sènior

Fundacion Clinic per a la Recerca Biomédica

Eligibility Criteria

Inclusion Criteria

  • Men and women of any ethnic group
  • Above 40 years old
  • Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines
  • Acute exacerbation of COPD according to the following criteria:
  • a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea

Exclusion Criteria

  • Less than 6 months expectancy of life
  • Needing of mechanical ventilation
  • Severe cardiovascular disease
  • Pregnancy
  • Previous diagnosis of depression/anxiety

Outcomes

Primary Outcomes

Efficacy of the intervention

Time Frame: 6 months

Counselling vs. usual care on re-hospitalizations

Secondary Outcomes

  • Impact of diagnosis(6 months)

Study Sites (1)

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