Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD (ADPHA-EPOC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Fundacion Clinic per a la Recerca Biomédica.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nestor Soler Porcar, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01520376
First received: January 25, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Anxiety
Depression
Behavioral: Psychiatric Counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Trial to Asses the Efficacy of an Early Psychiatric Intervention (Psychiatric Counseling) Compared to Usual Care in a Cohort of Patients Hospitalized for an Acute Exacerbation of COPD in Prevention of Re-exacerbation

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Efficacy of the intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Counselling vs. usual care on re-hospitalizations


Secondary Outcome Measures:
  • Impact of diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12


Estimated Enrollment: 169
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Counselling
People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months
Behavioral: Psychiatric Counselling
Visit by a psychiatrist at day-30 and day-180 after discarge
No Intervention: Usual care
People after screening (HADS test > 12 points) and send to their primary care physician
Behavioral: Psychiatric Counselling
Visit by a psychiatrist at day-30 and day-180 after discarge

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520376

Locations
Spain
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Arturo Huerta, MD    +34 679.788.559    ahuerta@clinic.ub.es   
Sub-Investigator: Arturo H Huerta, MD         
Principal Investigator: Nestor Soler, MD, PhD         
Sponsors and Collaborators
Nestor Soler Porcar
Investigators
Principal Investigator: Arturo Huerta, MD Hospital Clinic de Barcelona
  More Information

No publications provided

Responsible Party: Nestor Soler Porcar, Especialista Sènior, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01520376     History of Changes
Other Study ID Numbers: ADPHA-EPOC
Study First Received: January 25, 2012
Last Updated: January 25, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Mental Disorders
Behavioral Symptoms
Mood Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014