Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
ADPHA-EPOC
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
1 other identifier
interventional
169
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease
Started Oct 2011
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 25, 2012
CompletedFirst Posted
Study publicly available on registry
January 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJuly 6, 2018
July 1, 2018
2 years
January 25, 2012
July 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of the intervention
Counselling vs. usual care on re-hospitalizations
6 months
Secondary Outcomes (1)
Impact of diagnosis
6 months
Study Arms (2)
Counselling
ACTIVE COMPARATORPeople receiving a psychiatric evaluation after screening (HADS test \> 12 points) and revised at 1 and 6 months
Usual care
NO INTERVENTIONPeople after screening (HADS test \> 12 points) and send to their primary care physician
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Less than 6 months expectancy of life
- Needing of mechanical ventilation
- Severe cardiovascular disease
- Pregnancy
- Previous diagnosis of depression/anxiety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arturo Huerta, MD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Especialista Sènior
Study Record Dates
First Submitted
January 25, 2012
First Posted
January 27, 2012
Study Start
October 1, 2011
Primary Completion
October 1, 2013
Study Completion
April 1, 2014
Last Updated
July 6, 2018
Record last verified: 2018-07