Clinical trial NCT06599177: The Impact of Psychosocial Interventions in Patients with COPD
Official title: Patients with COPD: Assessment of Psychosocial Status and the Impact of Psychosocial Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Social Support
Intervention
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with severe and/or mental disorders.
* Patients with severe mental disability or advanced neurodegenerative disease. - Patients who do not wish to participate.

Primary outcomes:
measure: Multidimensional Scale of Perceinved Social Support (MSPSS)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
measure: Patient Health Questionnaire (PHQ-4)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
measure: Financial Ability Scale (FAS)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
measure: Test of the Adherence to Inhalers (TAI)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
measure: Sort Form (SF-12)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
measure: Clinical COPD Questionnaire (CCQ)
timeFrame: Through study completion, an average of a year and a half (1.5 years).
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University of Crete
state: Crete
Study officials:
affiliation: Department of Social Medicine, School of Medicine, University of Crete
name: Ioanna Tsiligianni, Associate professor
role: STUDY_CHAIR
affiliation: Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of Crete
name: Sophia Schiza, Professor of Pulmonology
role: STUDY_DIRECTOR
affiliation: Department of Psychology, University of Crete
name: Evangelos Karademas, Professor of Psychology
role: STUDY_DIRECTOR
affiliation: Department of Social Medicine, School of Medicine, University of Crete
name: Antonia Aravantinou Karlatou, Social Worker MSc, PhDc
role: PRINCIPAL_INVESTIGATOR
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