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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918731
• Other study ID #: COPDSELF-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: June 2023
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Self Management
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.

Locations

Country	Name	City	State
Greece	University of Crete	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessement of Quality of life	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	6 months
Primary	Assessment of Functional status	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.	6 months
Primary	Assessment of Depression	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.	6 months
Primary	Assessement of Anxiety	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.	6 months
Primary	Assessement of Patient education	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 months
Primary	Assessment of Functional status	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.	6 months
Primary	Assessement of Patient education	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.	6 months