The Impact of Psychosocial Interventions in Patients with COPD

September 12, 2024 updated by: Antonia Aravantinou Karlatou, University of Crete

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Crete
      • Heraklion, Crete, Greece, 71003
        • University of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
These participants will receive the informational leaflet
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.
No Intervention: Control group
These participants will not receive the informational leaflet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of a year and a half (1.5 years).
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.
Through study completion, an average of a year and a half (1.5 years).
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).
Through study completion, an average of a year and a half (1.5 years).
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.
Through study completion, an average of a year and a half (1.5 years).
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.
Through study completion, an average of a year and a half (1.5 years).
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.
Through study completion, an average of a year and a half (1.5 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Crete

Investigators

  • Study Chair: Ioanna Tsiligianni, Associate professor, Department of Social Medicine, School of Medicine, University of Crete
  • Study Director: Sophia Schiza, Professor of Pulmonology, Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of Crete
  • Study Director: Evangelos Karademas, Professor of Psychology, Department of Psychology, University of Crete
  • Principal Investigator: Antonia Aravantinou Karlatou, Social Worker MSc, PhDc, Department of Social Medicine, School of Medicine, University of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2024

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

September 8, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56/28.03.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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