Chronic Obstructive Pulmonary DiseaseADPHA-EPOCNCT01520376
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD
A study testing Counselling in people with Chronic Obstructive Pulmonary Disease and Anxiety, run by Nestor Soler Porcar, MD, PhD at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Anxiety, Depression
- What is being tested?
- Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- Less than 6 months expectancy of life
- Needing of mechanical ventilation
- Severe cardiovascular disease
- Pregnancy
- Previous diagnosis of depression/anxiety
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundacio Clinic Per la Recerca Biomèdica - Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Anxiety, Depression
- Being tested
- Counselling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounsellingBehavioural
Visit by a psychiatrist at day-30 and day-180 after discarge
| Study group | Role | What they receive |
|---|---|---|
| Counselling | Active comparator | People receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months Receives: Behavioral: Counselling |
| Usual care | No intervention | People after screening (HADS test > 12 points) and send to their primary care physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the intervention
Counselling vs. usual care on re-hospitalizations
Measured: 6 months
Secondary outcomes (1)
Impact of diagnosis
Anxiety/depression diagnosis on number of exacerbations at 1 and 6 months, comparing patients with screening on HADS test > 12
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nestor Soler Porcar, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nestor Soler Porcar, MD, PhD, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Arturo Huerta, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520376
- Sponsor's protocol ID
- ADPHA-EPOC
- Acronym
- ADPHA-EPOC
- Status last verified
- Jul 2018
- First submitted
- 25 Jan 2012
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01520376
- Acronym / sponsor ID
- ADPHA-EPOC / ADPHA-EPOC
- Conditions
- Chronic Obstructive Pulmonary Disease, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Nestor Soler Porcar, MD, PhDUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselling | Active comparator | Behavioral: CounsellingPeople receiving a psychiatric evaluation after screening (HADS test > 12 points) and revised at 1 and 6 months |
| Usual care | No intervention | –People after screening (HADS test > 12 points) and send to their primary care physician |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- Less than 6 months expectancy of life
- Needing of mechanical ventilation
- Severe cardiovascular disease
- Pregnancy
- Previous diagnosis of depression/anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounsellingVisit by a psychiatrist at day-30 and day-180 after discarge | Behavioural | Counselling |
Primary outcome
Efficacy of the intervention
Time frame: 6 months
Counselling vs. usual care on re-hospitalizations
1 secondary outcome
Impact of diagnosis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Huerta, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling in people with Chronic Obstructive Pulmonary Disease and Anxiety, run by Nestor Soler Porcar, MD, PhD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.