The Impact of Psychosocial Interventions in Patients with COPD

NCT06599177 | Active Not Recruiting DMC

• 1 other identifier: 56/28.03.2024
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Social Support; Intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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).

  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.

  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.

  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.

  Through study completion, an average of a year and a half (1.5 years).

Study Arms (2)

Intervention group

EXPERIMENTAL

These participants will receive the informational leaflet

Other: Informational leaflet

Control group

NO INTERVENTION

These participants will not receive the informational leaflet

Interventions

Informational leaflet 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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

University of Crete

Heraklion, Crete, 71003, Greece

Location

Related Publications (7)

• 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.

  PMID: 29386893 BACKGROUND

• Burney 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.

  PMID: 24353008 BACKGROUND

• Christodoulaki 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.

  PMID: 35728338 BACKGROUND

• Coventry 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.

  PMID: 22054636 BACKGROUND

• Ierodiakonou 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.

  PMID: 32977779 BACKGROUND

• Ware 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.

  PMID: 8628042 BACKGROUND

• Kontodimopoulos 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.

  PMID: 17900374 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ioanna Tsiligianni, Associate professor

  Department of Social Medicine, School of Medicine, University of Crete

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Antonia Aravantinou Karlatou, Social Worker MSc, PhDc

  Department of Social Medicine, School of Medicine, University of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 8, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GR (1)