Back to resultsAnxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD (ADPHA-EPOC)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Counselling
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Counselling
Usual care
Arm Description
People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months
People after screening (HADS test > 12 points) and send to their primary care physician
Outcomes
Primary Outcome Measures
Efficacy of the intervention
Counselling vs. usual care on re-hospitalizations
Secondary Outcome Measures
Impact of diagnosis
Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12
Full Information
NCT ID
NCT01520376
First Posted
January 25, 2012
Last Updated
July 5, 2018
Sponsor
Nestor Soler Porcar, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT01520376
Brief Title
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
Acronym
ADPHA-EPOC
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nestor Soler Porcar, MD, PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Anxiety, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Counselling
Arm Type
Active Comparator
Arm Description
People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
People after screening (HADS test > 12 points) and send to their primary care physician
Intervention Type
Behavioral
Intervention Name(s)
Counselling
Intervention Description
Visit by a psychiatrist at day-30 and day-180 after discarge
Primary Outcome Measure Information:
Title
Efficacy of the intervention
Description
Counselling vs. usual care on re-hospitalizations
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Impact of diagnosis
Description
Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Huerta, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
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