The Impact of Psychosocial Interventions in Patients with COPD

NCT06599177 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Crete

    lead OTHER

Principal Investigators

  • Ioanna Tsiligianni, Associate professor · Department of Social Medicine, School of Medicine, University of Crete

  • Sophia Schiza, Professor of Pulmonology · Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of Crete

  • Evangelos Karademas, Professor of Psychology · Department of Psychology, University of Crete

  • Antonia Aravantinou Karlatou, Social Worker MSc, PhDc · Department of Social Medicine, School of Medicine, University of Crete

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-08
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06599177 on ClinicalTrials.gov