Chronic Obstructive Pulmonary Disease (COPD)NCT06599177
The Impact of Psychosocial Interventions in Patients with COPD
A study testing Informational leaflet in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Crete at 1 site in Greece.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common exacerbating, non-communicable diseases. It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. Given the above, there is an international need to develop appropriate strategies for its management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Informational leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGreece
- Study dates
- 8 Sep 2024to 28 Feb 2026
- 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
- Adult patients with a confirmed diagnosis of COPD.
- Participants should be attended by the above healthcare departments in the Heraklion Prefecture.
- Know the Greek dialect.
- Have the ability to sign a consent form.
Who cannot join
- Patients with severe and/or mental disorders.
- Patients with severe mental disability or advanced neurodegenerative disease. - Patients who do not wish to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients with COPD: Assessment of Psychosocial Status and the Impact of Psychosocial Interventions
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common exacerbating, non-communicable diseases. It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. Given the above, there is an international need to develop appropriate strategies for its management. COPD affects both the physical and psychosocial well-being of patients. Studies have shown that anxiety, depression, lack of social support and poor financial status are associated with more frequent exacerbations, hospital readmissions, nonadherence to treatment and worse quality of life for patients. Therefore, socioeconomic and psychological factors play a critical role in COPD. The psychosocial support of patients with COPD it is likely to be an important method for improving their health status and therefore their quality of life. The aim of this PhD thesis is to assess the psychosocial status and the impact of psychosocial information-interventions in patients with COPD. For this purpose, a prospective study of mixed methodology design (questionnaires, interviews) as well as psychosocial interventions will be conducted in patients with COPD who are attended by Pulmonary Departments of Hospitals (Outpatient Clinics, Clinics), by Local Health Units (TOMY), Regional Clinics in the prefecture of Heraklion. Interventions will include counseling for 6 months/information about services, patient benefits, support, and patients will receive a relevant form. For the implementation of the study, they will use the investigative tools (questionnaires) for the patient's health status/quality of life (SF-12-CCQ), treatment adherence (TAI), mental status (PHQ-4 includes PHQ-2 for depression and GAD-2 for anxiety) and socioeconomic status (MSPSS, FAS). Then a qualitative part will take place with an interview. At the end of 6 months the participants will be asked to answer again the same questionnaires and a partially modified interview, so that the effectiveness of the psychosocial interventions they received. Their responses will be recorded and the results will be analyzed. This study is expected to contribute to a better management of patients with COPD.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common exacerbating, non-communicable diseases. It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. Given the above, there is an international need to develop appropriate strategies for its management. COPD affects both the physical and psychosocial well-being of patients. Studies have shown that anxiety, depression, lack of social support and poor financial status are associated with more frequent exacerbations, hospital readmissions, nonadherence to treatment and worse quality of life for patients. Therefore, socioeconomic and psychological factors play a critical role in COPD. The psychosocial support of patients with COPD it is likely to be an important method for improving their health status and therefore their quality of life. The aim of this PhD thesis is to assess the psychosocial status and the impact of psychosocial information-interventions in patients with COPD. For this purpose, a prospective study of mixed methodology design (questionnaires, interviews) as well as psychosocial interventions will be conducted in patients with COPD who are attended by Pulmonary Departments of Hospitals (Outpatient Clinics, Clinics), by Local Health Units (TOMY), Regional Clinics in the prefecture of Heraklion. Interventions will include counseling for 6 months/information about services, patient benefits, support, and patients will receive a relevant form. For the implementation of the study, they will use the investigative tools (questionnaires) for the patient's health status/quality of life (SF-12-CCQ), treatment adherence (TAI), mental status (PHQ-4 includes PHQ-2 for depression and GAD-2 for anxiety) and socioeconomic status (MSPSS, FAS). Then a qualitative part will take place with an interview. At the end of 6 months the participants will be asked to answer again the same questionnaires and a partially modified interview, so that the effectiveness of the psychosocial interventions they received. Their responses will be recorded and the results will be analyzed. This study is expected to contribute to a better management of patients with COPD.
- Being tested
- Informational leaflet
- Keywords
- COPD, Social Support, Intervention
- 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.
Informational leafletOther
An informational leaflet describing:
- Information on benefits to which they are entitled and how to receive them.
- Information and linkage to support services in the community.
- Information on how to obtain health care materials (insured, uninsured).
- Information on relevant support associations/voluntary groups in the community.
- Information on employment programs.
- Activation of patient\'s supportive social network/or referral to home help programs if they are a lonely person or in need of support.
- Individualized assessment of the patient\'s needs.
- Design of a plan for individualised psychosocial intervention (focus personal intervention).
- Patient education about existing social support networks in the community and how to find them.
- Educate patients about available resources in the community (benefits, services).
- Patient referral/advocacy to community services.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | These participants will receive the informational leaflet Receives: Other: Informational leaflet |
| Control group | No intervention | These participants will not receive the informational leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Scale of Perceinved Social Support (MSPSS)
To assess patients perceived social support, the Multidimensional Scale of Perceived Social Support (MSPSS) (Zimet et al., 1988), translated and weighted in Greek (Theofilou, 2015), will be used.The MSPSS includes 12 questions in 3 domains of perceived social support (family, friends, significant others) with 4 items in each subscale, ranging from 1-7 (likert-type) with a total score of minimum 12 and maximum 84. Higher scores indicate greater social support. Scores 12-35 indicate low perceived social support, scores 36-60 indicate moderate perceived social support, and scores 61-84 indicate high perceived social support.
Measured: Through study completion, an average of a year and a half (1.5 years).
Patient Health Questionnaire (PHQ-4)
To assess the mental state of the patients (anxiety and depression), the Patient Health Questionnaire (PHQ-4) (Löwe et al., 2010), translated and weighted in Greek (Christodoulaki et al., 2022), will be used. The PHQ-4 is a brief assessment of anxiety and depression including 4 questions. Questions 1 and 2 are subscales of the anxiety assessment of the GAD-2 exploratory instrument, while questions 3 and. 4 are subscales of the depression assessment of the PHQ-2 exploratory instrument. The PHQ-4 includes 4 questions in the range 0-3 (likert-type) with a total score of 0 to 12. The higher the score the less anxiety/depression. A score above 3 on either indicates that further assessment with the PHQ-9 Patient Health Questionnaire or the GAD-7 Generalized Anxiety Disorder Scale should be done.
Measured: Through study completion, an average of a year and a half (1.5 years).
Financial Ability Scale (FAS)
The Financial Ability Scale (FAS) questionnaire, translated into Greek (Koutsimpou et al., 2020), will be used to assess the financial status of the patients. The FAS includes 12 likert-type questions (ranging from no, little, moderate, good, very good).
Measured: Through study completion, an average of a year and a half (1.5 years).
Test of the Adherence to Inhalers (TAI)
To assess patients adherence to treatment, the Test of the Adherence to Inhalers (TAI) questionnaire (Plaza et al., 2016), translated and weighted in Greek (Ierodiakonou et al., 2020), will be used.The TAI includes 12 questions ranging from 1-5 (likert type) with a total score of minimum 10 and maximum 50, which classifies patients adherence to treatment and indicates specific behavioural patterns (voluntary, involuntary, etc.) of adherence.
Measured: Through study completion, an average of a year and a half (1.5 years).
Sort Form (SF-12)
The Sort Form (SF-12) questionnaire (Ware and Sherbourne, 1992), often used as a quality of life assessment questionnaire, translated and weighted in Greek (Kontodimopoulos et al., 2007), will be used to assess the patients health overview.The SF-12 is a short form of the SF-36 questionnaire and studies 4 domains of the patients health: physical role, physical functioning, emotional role, mental health. Each dimension is rated on a scale from 0 to 100, with 0 points representing worse health-related quality of life, and 100 points representing better health-related quality of life.
Measured: Through study completion, an average of a year and a half (1.5 years).
Clinical COPD Questionnaire (CCQ)
For the assessment of the patients quality of life, the Clinical COPD Questionnaire (CCQ) (van der Molen et al., 2003), translated and weighted in Greek (Tsiligianni et al., 2012), (Papadopoulos et al., 2011), will be used. The CCQ includes 10 questions ranging from 0-6 (likert-type), where patients are asked to recall their experiences in the last 24 hours. The higher the score, the worse the patients health status.
Measured: Through study completion, an average of a year and a half (1.5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Sep 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will complete a questionnaire for this study and subsequently will get interviewed. Then, half of them will be randomly assigned to intervention group and control group, the intervention group participants will receive an informational leaflet that will provide information regarding psychosocial support. After, six (6) months all participants will be contacted by the P.I. to re-complete each questionnaire and repeat the interview.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Aravantinou Karlatou, University of Crete
- Investigators
- Ioanna Tsiligianni, Associate professor, Study chair, Department of Social Medicine, School of Medicine, University of CreteSophia Schiza, Professor of Pulmonology, Study director, Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of CreteEvangelos Karademas, Professor of Psychology, Study director, Department of Psychology, University of CreteAntonia Aravantinou Karlatou, Social Worker MSc, PhDc, Principal investigator, Department of Social Medicine, School of Medicine, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599177
- Sponsor's protocol ID
- 56/28.03.2024
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brien SB, Stuart B, Dickens AP, Kendrick T, Jordan RE, Adab P, Thomas M. Independent determinants of disease-related quality of life in COPD - scope for nonpharmacologic interventions? Int J Chron Obstruct Pulmon Dis. 2018 Jan 9;13:247-256. doi: 10.2147/COPD.S152955. eCollection 2018.
PubMed 29386893Burney P, Jithoo A, Kato B, Janson C, Mannino D, Nizankowska-Mogilnicka E, Studnicka M, Tan W, Bateman E, Kocabas A, Vollmer WM, Gislason T, Marks G, Koul PA, Harrabi I, Gnatiuc L, Buist S; Burden of Obstructive Lung Disease (BOLD) Study. Chronic obstructive pulmonary disease mortality and prevalence: the associations with smoking and poverty--a BOLD analysis. Thorax. 2014 May;69(5):465-73. doi: 10.1136/thoraxjnl-2013-204460. Epub 2013 Dec 18.
PubMed 24353008Christodoulaki A, Baralou V, Konstantakopoulos G, Touloumi G. Validation of the Patient Health Questionnaire-4 (PHQ-4) to screen for depression and anxiety in the Greek general population. J Psychosom Res. 2022 Sep;160:110970. doi: 10.1016/j.jpsychores.2022.110970. Epub 2022 Jun 16.
PubMed 35728338Coventry PA, Gemmell I, Todd CJ. Psychosocial risk factors for hospital readmission in COPD patients on early discharge services: a cohort study. BMC Pulm Med. 2011 Nov 4;11:49. doi: 10.1186/1471-2466-11-49.
PubMed 22054636Ierodiakonou D, Sifaki-Pistolla D, Kampouraki M, Poulorinakis I, Papadokostakis P, Gialamas I, Athanasiou P, Bempi V, Lampraki I, Tsiligianni I; Greek UNLOCK group. Adherence to inhalers and comorbidities in COPD patients. A cross-sectional primary care study from Greece. BMC Pulm Med. 2020 Sep 25;20(1):253. doi: 10.1186/s12890-020-01296-3.
PubMed 32977779Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.
PubMed 17900374
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients with COPD: Assessment of Psychosocial Status and the Impact of Psychosocial Interventions
- ClinicalTrials.gov ID
- NCT06599177
- Acronym / sponsor ID
- 56/28.03.2024
- Keywords
- COPD, Social Support, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 8 Sep 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common exacerbating, non-communicable diseases. It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. Given the above, there is an international need to develop appropriate strategies for its management. COPD affects both the physical and psychosocial well-being of patients. Studies have shown that anxiety, depression, lack of social support and poor financial status are associated with more frequent exacerbations, hospital readmissions, nonadherence to treatment and worse quality of life for patients. Therefore, socioeconomic and psychological factors play a critical role in COPD. The psychosocial support of patients with COPD it is likely to be an important method for improving their health status and therefore their quality of life. The aim of this PhD thesis is to assess the psychosocial status and the impact of psychosocial information-interventions in patients with COPD. For this purpose, a prospective study of mixed methodology design (questionnaires, interviews) as well as psychosocial interventions will be conducted in patients with COPD who are attended by Pulmonary Departments of Hospitals (Outpatient Clinics, Clinics), by Local Health Units (TOMY), Regional Clinics in the prefecture of Heraklion. Interventions will include counseling for 6 months/information about services, patient benefits, support, and patients will receive a relevant form. For the implementation of the study, they will use the investigative tools (questionnaires) for the patient's health status/quality of life (SF-12-CCQ), treatment adherence (TAI), mental status (PHQ-4 includes PHQ-2 for depression and GAD-2 for anxiety) and socioeconomic status (MSPSS, FAS). Then a qualitative part will take place with an interview. At the end of 6 months the participants will be asked to answer again the same questionnaires and a partially modified interview, so that the effectiveness of the psychosocial interventions they received. Their responses will be recorded and the results will be analyzed. This study is expected to contribute to a better management of patients with COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is one of the most common exacerbating, non-communicable diseases. It is the third leading cause of death worldwide, causing 3.23 million deaths in 2019. Given the above, there is an international need to develop appropriate strategies for its management. COPD affects both the physical and psychosocial well-being of patients. Studies have shown that anxiety, depression, lack of social support and poor financial status are associated with more frequent exacerbations, hospital readmissions, nonadherence to treatment and worse quality of life for patients. Therefore, socioeconomic and psychological factors play a critical role in COPD. The psychosocial support of patients with COPD it is likely to be an important method for improving their health status and therefore their quality of life. The aim of this PhD thesis is to assess the psychosocial status and the impact of psychosocial information-interventions in patients with COPD. For this purpose, a prospective study of mixed methodology design (questionnaires, interviews) as well as psychosocial interventions will be conducted in patients with COPD who are attended by Pulmonary Departments of Hospitals (Outpatient Clinics, Clinics), by Local Health Units (TOMY), Regional Clinics in the prefecture of Heraklion. Interventions will include counseling for 6 months/information about services, patient benefits, support, and patients will receive a relevant form. For the implementation of the study, they will use the investigative tools (questionnaires) for the patient's health status/quality of life (SF-12-CCQ), treatment adherence (TAI), mental status (PHQ-4 includes PHQ-2 for depression and GAD-2 for anxiety) and socioeconomic status (MSPSS, FAS). Then a qualitative part will take place with an interview. At the end of 6 months the participants will be asked to answer again the same questionnaires and a partially modified interview, so that the effectiveness of the psychosocial interventions they received. Their responses will be recorded and the results will be analyzed. This study is expected to contribute to a better management of patients with COPD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will complete a questionnaire for this study and subsequently will get interviewed. Then, half of them will be randomly assigned to intervention group and control group, the intervention group participants will receive an informational leaflet that will provide information regarding psychosocial support. After, six (6) months all participants will be contacted by the P.I. to re-complete each questionnaire and repeat the interview.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Informational leafletThese participants will receive the informational leaflet |
| Control group | No intervention | –These participants will not receive the informational leaflet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with a confirmed diagnosis of COPD.
- Participants should be attended by the above healthcare departments in the Heraklion Prefecture.
- Know the Greek dialect.
- Have the ability to sign a consent form.
Key exclusion criteria (2 listed)
- Patients with severe and/or mental disorders.
- Patients with severe mental disability or advanced neurodegenerative disease. - Patients who do not wish to participate.
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 |
|---|---|---|
| Informational leafletAn informational leaflet describing: * Information on benefits to which they are entitled and how to receive them. * Information and linkage to support services in the community. * Information on how to obtain health care materials (insured, uninsured). * Information on relevant support associations/voluntary groups in the community. * Information on employment programs. * Activation of patient\'s supportive social network/or referral to home help programs if they are a lonely person or in need of support. * Individualized assessment of the patient\'s needs. * Design of a plan for individualised psychosocial intervention (focus personal intervention). * Patient education about existing social support networks in the community and how to find them. * Educate patients about available resources in the community (benefits, services). * Patient referral/advocacy to community services. | Other | Intervention group |
Primary outcome
Multidimensional Scale of Perceinved Social Support (MSPSS)
Time frame: Through study completion, an average of a year and a half (1.5 years).
To assess patients perceived social support, the Multidimensional Scale of Perceived Social Support (MSPSS) (Zimet et al., 1988), translated and weighted in Greek (Theofilou, 2015), will be used.The MSPSS includes 12 questions in 3 domains of perceived social support (family, friends, significant others) with 4 items in each subscale, ranging from 1-7 (likert-type) with a total score of minimum 12 and maximum 84. Higher scores indicate greater social support. Scores 12-35 indicate low perceived social support, scores 36-60 indicate moderate perceived social support, and scores 61-84 indicate high perceived social support.
Patient Health Questionnaire (PHQ-4)
Time frame: Through study completion, an average of a year and a half (1.5 years).
To assess the mental state of the patients (anxiety and depression), the Patient Health Questionnaire (PHQ-4) (Löwe et al., 2010), translated and weighted in Greek (Christodoulaki et al., 2022), will be used. The PHQ-4 is a brief assessment of anxiety and depression including 4 questions. Questions 1 and 2 are subscales of the anxiety assessment of the GAD-2 exploratory instrument, while questions 3 and. 4 are subscales of the depression assessment of the PHQ-2 exploratory instrument. The PHQ-4 includes 4 questions in the range 0-3 (likert-type) with a total score of 0 to 12. The higher the score the less anxiety/depression. A score above 3 on either indicates that further assessment with the PHQ-9 Patient Health Questionnaire or the GAD-7 Generalized Anxiety Disorder Scale should be done.
Financial Ability Scale (FAS)
Time frame: Through study completion, an average of a year and a half (1.5 years).
The Financial Ability Scale (FAS) questionnaire, translated into Greek (Koutsimpou et al., 2020), will be used to assess the financial status of the patients. The FAS includes 12 likert-type questions (ranging from no, little, moderate, good, very good).
Test of the Adherence to Inhalers (TAI)
Time frame: Through study completion, an average of a year and a half (1.5 years).
To assess patients adherence to treatment, the Test of the Adherence to Inhalers (TAI) questionnaire (Plaza et al., 2016), translated and weighted in Greek (Ierodiakonou et al., 2020), will be used.The TAI includes 12 questions ranging from 1-5 (likert type) with a total score of minimum 10 and maximum 50, which classifies patients adherence to treatment and indicates specific behavioural patterns (voluntary, involuntary, etc.) of adherence.
Sort Form (SF-12)
Time frame: Through study completion, an average of a year and a half (1.5 years).
The Sort Form (SF-12) questionnaire (Ware and Sherbourne, 1992), often used as a quality of life assessment questionnaire, translated and weighted in Greek (Kontodimopoulos et al., 2007), will be used to assess the patients health overview.The SF-12 is a short form of the SF-36 questionnaire and studies 4 domains of the patients health: physical role, physical functioning, emotional role, mental health. Each dimension is rated on a scale from 0 to 100, with 0 points representing worse health-related quality of life, and 100 points representing better health-related quality of life.
Clinical COPD Questionnaire (CCQ)
Time frame: Through study completion, an average of a year and a half (1.5 years).
For the assessment of the patients quality of life, the Clinical COPD Questionnaire (CCQ) (van der Molen et al., 2003), translated and weighted in Greek (Tsiligianni et al., 2012), (Papadopoulos et al., 2011), will be used. The CCQ includes 10 questions ranging from 0-6 (likert-type), where patients are asked to recall their experiences in the last 24 hours. The higher the score, the worse the patients health status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 29386893Brien SB, Stuart B, Dickens AP, Kendrick T, Jordan RE, Adab P, Thomas M. Independent determinants of disease-related quality of life in COPD - scope for nonpharmacologic interventions? Int J Chron Obstruct Pulmon Dis. 2018 Jan 9;13:247-256. doi: 10.2147/COPD.S152955. eCollection 2018.
- Background: PubMed 24353008Burney P, Jithoo A, Kato B, Janson C, Mannino D, Nizankowska-Mogilnicka E, Studnicka M, Tan W, Bateman E, Kocabas A, Vollmer WM, Gislason T, Marks G, Koul PA, Harrabi I, Gnatiuc L, Buist S; Burden of Obstructive Lung Disease (BOLD) Study. Chronic obstructive pulmonary disease mortality and prevalence: the associations with smoking and poverty--a BOLD analysis. Thorax. 2014 May;69(5):465-73. doi: 10.1136/thoraxjnl-2013-204460. Epub 2013 Dec 18.
- Background: PubMed 35728338Christodoulaki A, Baralou V, Konstantakopoulos G, Touloumi G. Validation of the Patient Health Questionnaire-4 (PHQ-4) to screen for depression and anxiety in the Greek general population. J Psychosom Res. 2022 Sep;160:110970. doi: 10.1016/j.jpsychores.2022.110970. Epub 2022 Jun 16.
- Background: PubMed 22054636Coventry PA, Gemmell I, Todd CJ. Psychosocial risk factors for hospital readmission in COPD patients on early discharge services: a cohort study. BMC Pulm Med. 2011 Nov 4;11:49. doi: 10.1186/1471-2466-11-49.
- Background: PubMed 32977779Ierodiakonou D, Sifaki-Pistolla D, Kampouraki M, Poulorinakis I, Papadokostakis P, Gialamas I, Athanasiou P, Bempi V, Lampraki I, Tsiligianni I; Greek UNLOCK group. Adherence to inhalers and comorbidities in COPD patients. A cross-sectional primary care study from Greece. BMC Pulm Med. 2020 Sep 25;20(1):253. doi: 10.1186/s12890-020-01296-3.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 17900374Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.
- Individual participant dataSharing planned: Undecided
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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.
Ioanna Tsiligianni, Associate professor study chair
Department of Social Medicine, School of Medicine, University of Crete
Sophia Schiza, Professor of Pulmonology study director
Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of Crete
Evangelos Karademas, Professor of Psychology study director
Department of Psychology, University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational leaflet in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Crete at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Greece. 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?
Results are not available in the source record.
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?
Multidimensional Scale of Perceinved Social Support (MSPSS) (time frame: Through study completion, an average of a year and a half (1.5 years).). The study lists 6 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 NCT06599177, which also lists 7 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 19 Sep 2024.