Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01520376
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Nestor Soler Porcar, MD, PhD, Fundacion Clinic per a la Recerca Biomédica

Tracking Information
First Submitted Date  ICMJE January 25, 2012
First Posted Date  ICMJE January 27, 2012
Last Update Posted Date July 6, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
Efficacy of the intervention [ Time Frame: 6 months ]
Counselling vs. usual care on re-hospitalizations
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01520376 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
Impact of diagnosis [ Time Frame: 6 months ]
Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Anxiety
  • Depression
Intervention  ICMJE Behavioral: Counselling
Visit by a psychiatrist at day-30 and day-180 after discarge
Study Arms  ICMJE
  • Active Comparator: Counselling
    People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months
    Intervention: Behavioral: Counselling
  • No Intervention: Usual care
    People after screening (HADS test > 12 points) and send to their primary care physician
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
169
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01520376
Other Study ID Numbers  ICMJE ADPHA-EPOC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestor Soler Porcar, MD, PhD, Fundacion Clinic per a la Recerca Biomédica
Study Sponsor  ICMJE Nestor Soler Porcar, MD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arturo Huerta, MD Hospital Clinic of Barcelona
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP