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

NCT ID: NCT05918731

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-03-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care Group

Patients who were assigned to receive usual care were instructed to continue up with their regular medical appointments and their usual check-ups/reviews and if they had any questions, to call the health coach.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Self-management Intervention Group

In the intervention group, a self-management program was implemented.

Group Type: ACTIVE_COMPARATOR

Self Management

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ioanna Tsiligianni

Role: STUDY_CHAIR

University of Crete, Greece

Locations

University of Crete

Heraklion, , Greece

Countries

Greece

Other Identifiers

COPDSELF-1

Identifier Type: -

Identifier Source: org_study_id