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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Self Management

• Registration Number: NCT05918731
• Lead Sponsor: University of Crete

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-08-30
• Study Completion: 2021-03-30
• Study First Submitted: 2023-05-24
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-22
• Last Update Submitted: 2023-06-22
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management Intervention Group	Self Management	In the intervention group, a self-management program was implemented.

Primary Outcome Measures

Name	Time	Method
Assessment of Functional status	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.
Assessement of Anxiety	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.
Assessement of Quality of life	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
Assessment of Depression	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.
Assessement of Patient education	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.

Trial Locations

Locations (1)

University of Crete; 🇬🇷 Heraklion, Greece