COPDIMPROVENCT03470025
Improving Psychosocial Well-being in COPD Patients in Rehabilitation
A study testing Psychological Intervention in people with COPD, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Psychological Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Mini-Mental State Examination (MMSE) ≥ 26
- 6 Minute Walking Test ≥ 90 meters , at admission
- Obtaining Written Informed Consent
Who cannot join
- Comorbidity influencing respiratory ability and functionality
- Delta 6 Minute Walking Distance < 60 meters, at time of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being
Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms [GOLD, 2017].
Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities.
Read more
Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients.
A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.
Read the detailed description
In this pilot study we will perform two different methodologies of the Psychological Intervention: a telephone-based Psychological Intervention and combined face to face \& telephone-based Psychological Intervention, integrating the COPD rehabilitation.
The study will be carried out in a real life setting. An initial sample of 36 COPD patients satisfying the inclusion criteria and accepting the participation of the study will be enrolled at the PR Unit of the IRCCS "San Raffaele Pisana" Roma-Italy. The study enrollment period will be of maximum six months, the treatment period is of six months, and the interim treatment evaluation is of three months will be performed. Max study duration will be of 12 months.
The participants will be recruited prospectively from consecutively admitted patients to the inpatient PR Unit. Participants will be required to have the diagnosis of COPD according to the ATS' Guideline [Qaseem et al., 2011]. All participants will sign informed consent approved by the Institutional Ethic Committee.
- Conditions
- COPD
- Being tested
- Psychological Intervention
- Keywords
- Rehabilitation, Psychological Intervention, Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological InterventionOther
Also called Medical therapy
- F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist .
- TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist.
- CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Intervention | Experimental | A weekly combined face to face \& telephone-based PI (F-TPI); Psychological Intervention and medical therapy Receives: Other: Psychological Intervention |
| A telephone-based PI (TPI) | Experimental | Psychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy Receives: Other: Psychological Intervention |
| Optimal medical therapy | No intervention | Patients will receive optimal medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire
the St. George's Respiratory Questionnaire score
Measured: day 0 to day 182
Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health
the Short Form Health Survey General and Mental Health score
Measured: day 0 to day 182
Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire
the Quality Of Life Enjoyment And Satisfaction Questionnaire score
Measured: day 0 to day 182
Maintenance of Functional Exercise evaluated by the Six Minute Walking Test
the Six Minute Walking Test score
Measured: day 0 to day 182
Maintenance of Respiratory Capacity evaluated by the Borg scale
the Borg scale score
Measured: day 0 to day 182
Assessment of dyspnea in activities of daily living by the Medical Research Council scale
the Medical Research Council score
Measured: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire
the Maugeri Foundation Respiratory Failure score
Measured: day 0 to day 21 (period of the Pulmonary Rehabilitation)
Assessment of disability by the Barthel Index
Barthel Index score
Measured: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Secondary outcomes (4)
Change in psychological status evaluated by the Symptom Check List (SCL-90)
the SCL-90 scores
Measured: day 0 to day 182
Assessment of the severity of depression by the Beck Depression Inventory II
the Beck Depression Inventory score
Measured: day 0 to day 182
Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.
the State-Trait Anxiety Inventory scores
Measured: day 0 to day 182
Change in the use of the Coping Strategies evaluated by Brief-COPE
Brief-COPE
Measured: day 0 to day 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start10 Jan 2018
- Primary completion30 May 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulia Prinzi, MA, Principal investigator, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470025
- Sponsor's protocol ID
- RP 22/17
- Acronym
- IMPROVE
- Status last verified
- Jun 2023
- First submitted
- 6 Mar 2018
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
PubMed 16250744Celli B, Tetzlaff K, Criner G, Polkey MI, Sciurba F, Casaburi R, Tal-Singer R, Kawata A, Merrill D, Rennard S; COPD Biomarker Qualification Consortium. The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool. Insights from the COPD Biomarker Qualification Consortium. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1483-1493. doi: 10.1164/rccm.201508-1653OC.
PubMed 27332504Chen Q, Wu C, Gao Y, Chen L, Liu Y. A clinical study on the role of psychosomatic therapy in evaluation and treatment of patients with chronic obstructive pulmonary disease complicated with anxiety-depression disorder. Int J Clin Exp Med. 2015 Sep 15;8(9):16613-9. eCollection 2015.
PubMed 26629192Graydon JE, Ross E. Influence of symptoms, lung function, mood, and social support on level of functioning of patients with COPD. Res Nurs Health. 1995 Dec;18(6):525-33. doi: 10.1002/nur.4770180608.
PubMed 7480853Guell MR, Cejudo P, Ortega F, Puy MC, Rodriguez-Trigo G, Pijoan JI, Martinez-Indart L, Gorostiza A, Bdeir K, Celli B, Galdiz JB. Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up. Am J Respir Crit Care Med. 2017 Mar 1;195(5):622-629. doi: 10.1164/rccm.201603-0602OC.
PubMed 27611807Healy K. A Theory of Human Motivation by Abraham H. Maslow - reflection. Br J Psychiatry. 2016 Apr;208(4):313. doi: 10.1192/bjp.bp.115.179622. No abstract available.
PubMed 27036694Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
PubMed 1595997Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005 Apr;127(4):1205-11. doi: 10.1378/chest.127.4.1205.
PubMed 15821196Lazarus RS. Coping theory and research: past, present, and future. Psychosom Med. 1993 May-Jun;55(3):234-47. doi: 10.1097/00006842-199305000-00002. No abstract available.
PubMed 8346332Martinez FD. Early-Life Origins of Chronic Obstructive Pulmonary Disease. N Engl J Med. 2016 Sep 1;375(9):871-8. doi: 10.1056/NEJMra1603287. No abstract available.
PubMed 27579637Martinu T, Babyak MA, O'Connell CF, Carney RM, Trulock EP, Davis RD, Blumenthal JA, Palmer SM; INSPIRE Investigators. Baseline 6-min walk distance predicts survival in lung transplant candidates. Am J Transplant. 2008 Jul;8(7):1498-505. doi: 10.1111/j.1600-6143.2008.02264.x.
PubMed 18510641Maurer J, Rebbapragada V, Borson S, Goldstein R, Kunik ME, Yohannes AM, Hanania NA; ACCP Workshop Panel on Anxiety and Depression in COPD. Anxiety and depression in COPD: current understanding, unanswered questions, and research needs. Chest. 2008 Oct;134(4 Suppl):43S-56S. doi: 10.1378/chest.08-0342.
PubMed 18842932Perret JL, Walters EH, Abramson MJ, McDonald CF, Dharmage SC. The independent and combined effects of lifetime smoke exposures and asthma as they relate to COPD. Expert Rev Respir Med. 2014 Aug;8(4):503-14. doi: 10.1586/17476348.2014.905913. Epub 2014 May 16.
PubMed 24834459Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
PubMed 21810710
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being
- ClinicalTrials.gov ID
- NCT03470025
- Acronym / sponsor ID
- IMPROVE / RP 22/17
- Conditions
- COPD
- Keywords
- Rehabilitation, Psychological Intervention, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- 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.
Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms [GOLD, 2017].
Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities.
Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients.
A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.
Detailed description
In this pilot study we will perform two different methodologies of the Psychological Intervention: a telephone-based Psychological Intervention and combined face to face \& telephone-based Psychological Intervention, integrating the COPD rehabilitation.
The study will be carried out in a real life setting. An initial sample of 36 COPD patients satisfying the inclusion criteria and accepting the participation of the study will be enrolled at the PR Unit of the IRCCS "San Raffaele Pisana" Roma-Italy. The study enrollment period will be of maximum six months, the treatment period is of six months, and the interim treatment evaluation is of three months will be performed. Max study duration will be of 12 months.
The participants will be recruited prospectively from consecutively admitted patients to the inpatient PR Unit. Participants will be required to have the diagnosis of COPD according to the ATS' Guideline [Qaseem et al., 2011]. All participants will sign informed consent approved by the Institutional Ethic Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention | Experimental | Other: Psychological InterventionA weekly combined face to face \& telephone-based PI (F-TPI); Psychological Intervention and medical therapy |
| A telephone-based PI (TPI) | Experimental | Other: Psychological InterventionPsychological Intervention - A telephone-based PI (TPI); Psychological Intervention and medical therapy |
| Optimal medical therapy | No intervention | –Patients will receive optimal medical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD
- Mini-Mental State Examination (MMSE) ≥ 26
- 6 Minute Walking Test ≥ 90 meters , at admission
- Obtaining Written Informed Consent
Key exclusion criteria (2 listed)
- Comorbidity influencing respiratory ability and functionality
- Delta 6 Minute Walking Distance < 60 meters, at time of admission
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 |
|---|---|---|
| Psychological InterventionAlso: Medical therapy1. F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist . 2. TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist. 3. CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR. | Other | A telephone-based PI (TPI), Psychological Intervention |
Primary outcome
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire
Time frame: day 0 to day 182
the St. George's Respiratory Questionnaire score
Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health
Time frame: day 0 to day 182
the Short Form Health Survey General and Mental Health score
Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire
Time frame: day 0 to day 182
the Quality Of Life Enjoyment And Satisfaction Questionnaire score
Maintenance of Functional Exercise evaluated by the Six Minute Walking Test
Time frame: day 0 to day 182
the Six Minute Walking Test score
Maintenance of Respiratory Capacity evaluated by the Borg scale
Time frame: day 0 to day 182
the Borg scale score
Assessment of dyspnea in activities of daily living by the Medical Research Council scale
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )
the Medical Research Council score
Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation)
the Maugeri Foundation Respiratory Failure score
Assessment of disability by the Barthel Index
Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )
Barthel Index score
4 secondary outcomes
Change in psychological status evaluated by the Symptom Check List (SCL-90)
Time frame: day 0 to day 182
Assessment of the severity of depression by the Beck Depression Inventory II
Time frame: day 0 to day 182
Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.
Time frame: day 0 to day 182
Change in the use of the Coping Strategies evaluated by Brief-COPE
Time frame: day 0 to day 182
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 26 Jun 2023.
- Background: PubMed 16250744Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Background: PubMed 27332504Celli B, Tetzlaff K, Criner G, Polkey MI, Sciurba F, Casaburi R, Tal-Singer R, Kawata A, Merrill D, Rennard S; COPD Biomarker Qualification Consortium. The 6-Minute-Walk Distance Test as a Chronic Obstructive Pulmonary Disease Stratification Tool. Insights from the COPD Biomarker Qualification Consortium. Am J Respir Crit Care Med. 2016 Dec 15;194(12):1483-1493. doi: 10.1164/rccm.201508-1653OC.
- Background: PubMed 26629192Chen Q, Wu C, Gao Y, Chen L, Liu Y. A clinical study on the role of psychosomatic therapy in evaluation and treatment of patients with chronic obstructive pulmonary disease complicated with anxiety-depression disorder. Int J Clin Exp Med. 2015 Sep 15;8(9):16613-9. eCollection 2015.
- Background: PubMed 7480853Graydon JE, Ross E. Influence of symptoms, lung function, mood, and social support on level of functioning of patients with COPD. Res Nurs Health. 1995 Dec;18(6):525-33. doi: 10.1002/nur.4770180608.
- Background: PubMed 27611807Guell MR, Cejudo P, Ortega F, Puy MC, Rodriguez-Trigo G, Pijoan JI, Martinez-Indart L, Gorostiza A, Bdeir K, Celli B, Galdiz JB. Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up. Am J Respir Crit Care Med. 2017 Mar 1;195(5):622-629. doi: 10.1164/rccm.201603-0602OC.
- Background: PubMed 27036694Healy K. A Theory of Human Motivation by Abraham H. Maslow - reflection. Br J Psychiatry. 2016 Apr;208(4):313. doi: 10.1192/bjp.bp.115.179622. No abstract available.
- Background: PubMed 25359355Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
- Background: PubMed 1595997Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.
- Background: PubMed 15821196Kunik ME, Roundy K, Veazey C, Souchek J, Richardson P, Wray NP, Stanley MA. Surprisingly high prevalence of anxiety and depression in chronic breathing disorders. Chest. 2005 Apr;127(4):1205-11. doi: 10.1378/chest.127.4.1205.
- Background: PubMed 8346332Lazarus RS. Coping theory and research: past, present, and future. Psychosom Med. 1993 May-Jun;55(3):234-47. doi: 10.1097/00006842-199305000-00002. No abstract available.
- Background: PubMed 27579637Martinez FD. Early-Life Origins of Chronic Obstructive Pulmonary Disease. N Engl J Med. 2016 Sep 1;375(9):871-8. doi: 10.1056/NEJMra1603287. No abstract available.
- Background: PubMed 18510641Martinu T, Babyak MA, O'Connell CF, Carney RM, Trulock EP, Davis RD, Blumenthal JA, Palmer SM; INSPIRE Investigators. Baseline 6-min walk distance predicts survival in lung transplant candidates. Am J Transplant. 2008 Jul;8(7):1498-505. doi: 10.1111/j.1600-6143.2008.02264.x.
- Individual participant dataSharing planned: No
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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.
Giulia Prinzi, MA principal investigator
IRCCS San Raffaele Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Intervention in people with COPD, run by IRCCS San Raffaele Roma at 1 site in Italy.
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 4 inclusion and 2 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 26 Jun 2023. 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 Italy. 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?
Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire (time frame: day 0 to day 182). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470025, which also lists 22 linked publications.
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 26 Jun 2023.