The Impact of Psychosocial Interventions in Patients with COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-08

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group

These participants will receive the informational leaflet

Group Type EXPERIMENTAL

Informational leaflet

Intervention Type OTHER

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.

Control group

These participants will not receive the informational leaflet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Informational leaflet

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No