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Completed

NCT Number: NCT05918731

Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients Compared to Usual Care

Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Crete

Heraklion, 71110, Greece

About this study

To the best of our knowledge, no previous study has examined the effects of self-management programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized controlled trial with a post-test design, to evaluate the implementation and clinical effectiveness of a COPD self-management intervention compared to usual care in terms of the following outcomes: Quality of life, functional status, patient education, depression, and anxiety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged ≥18 years
  • had previously been given a physician-diagnosis of mild COPD
  • stable on their medications (no treatment modifications) in the last three months
  • able to speak, read and/or understand Greek

Exclusion criteria

  • refusal to participate
  • concurrent oncological diseases
  • severe cognitive impairment
  • neurological, or psychiatric disability

Treatment and study plan

Self Management

Behavioral

A "training book" was given to this group, which was created for the study. The implementation process followed a five-step approach including sessions once a month for five consecutive months with a coach and follow-up phone calls after the end of the sessions.To inspire and engage patients, the sessions included a variety of educational techniques, including knowledge transfer, discussion, hands-on training, and homework. Additionally, coaches received training in motivational interviewing methods. The self-management program and all the process of data collection is described in detail on the supplementary file.

Primary outcomes

  1. Assessement of Quality of life

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on Quality of life using Short-Form Health survey (SF-12) questionnaire. The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning

  2. Assessment of Functional status

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on functional status using COPD Clinical Questionnaire (CCQ) for clinically evaluating COPD.The Clinical COPD Questionnaire (CCQ) measures health status and can be used to assess health-related quality of life (HRQL). The overall CCQ consists of 10 items that are scored from 0 to 6. The final score is the sum of all items divided by 10. Higher scores indicate a worse health status.

  3. Assessment of Depression

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on depression using Beck Depression Inventory, 2nd edition (BDI).The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations.Scores range from zero to 60. Higher total scores indicate more severe depressive symptoms.

  4. Assessement of Anxiety

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on anxiety using Beck Anxiety Inventory (BAI). The BAI is a rating scale used to evaluate the severity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.

  5. Assessement of Patient education

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on patient education, using Health Education Impact Questionnaire (HeiQ), for evaluating the training intervention. Responses to 40 items are marked on a 4-point Likert scale, using the endpoints "strongly disagree/strongly agree". A higher score indicates stronger skills in the management of the chronic condition, except in the emotional distress dimension, which is negatively scored.

  6. Assessment of Functional status

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on functional status using Modified Medical Research Council Dyspnea Scale (mMRC) to assess dyspnea.The mMRC breathlessness scale ranges from grade 0 to 4. Higher scores indicate greater severity of breathlessness.

  7. Assessement of Patient education

    Time frame: 6 months

    Assessment of the potential effect of self-management intervention on patient education, using Health Literacy Questionnaire (HLQ), assessing literacy.The full HLQ provides nine individual scores based on an average of the items within each of the nine scales. Higher values indicate greater understanding or ability.

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Primary Healthcare Intervention Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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