Anxiety and Depression in Patients Hospitalizes for an Ac... | NCT01520376

Studies
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD

NCT01520376

Sponsor

Nestor Soler Porcar, MD, PhD

Status

Completed

Last Update Posted

Jul 6, 2018Actual

Enrollment

169Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Anxiety
Depression

Interventions

Counselling

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2013Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 25, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2018

Last Update Posted Date

Jul 6, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nestor Soler Porcar, MD, PhD, Especialista Sènior, Fundacion Clinic per a la Recerca BiomédicaSponsor-Investigator

Lead Sponsor

Nestor Soler Porcar, MD, PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

169Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Counselling	Active Comparator	People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months	Behavioral: Counselling
Usual care	No Intervention	People after screening (HADS test > 12 points) and send to their primary care physician

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Counselling	Behavioral	Visit by a psychiatrist at day-30 and day-180 after discarge	Counselling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of the intervention	Counselling vs. usual care on re-hospitalizations	6 months

Secondary Outcomes

Measure	Description	Time Frame
Impact of diagnosis	Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arturo Huerta, MD	Hospital Clinic of Barcelona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona		Barcelona	Catalonia	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided