Effect of Self Management Program on Clinical Status of COPD Patients

NCT ID: NCT02567474

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-06-30

Brief Summary

This study evaluates the effectiveness of self management programs based on 5A model on the lung function status, dyspnea and exercise tolerance in Chronic Obstructive Pulmonary Disease patients. Participants were randomly assigned to an intervention group or a control group. The control group were receiving standard practice care and the intervention group were receiving intervention in addition to standard practice care. The intervention content include implementation of a self management plan based on 5A model.

Detailed Description

5 A model implemented during a period of 12 weeks including 5 stags: assessment of behavior, beliefs and motivation of the patient (Assess); provide information about personal health risks and benefits of change (Advise); mutual contribution of patients and health care provider on setting realistic goals based on the patient's interest and confidence in their ability to change the behavior (Agree); help anticipate barriers and develop practical applications based on the identified patient's strategies, problem-solving techniques and social/environmental support (Assist) and specify plan for follow-up (Visits, Phone calls) and providing support in the course of follow up (Arrange).

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

control

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

self management intervention based on 5A model

Group Type: EXPERIMENTAL

5 A model

Intervention Type: BEHAVIORAL

self management program based on 5A model

Interventions

5 A model

self management program based on 5A model

Intervention Type: BEHAVIORAL

Other Intervention Names

self managment

Eligibility Criteria

Inclusion Criteria

• certified diagnosis of COPD with moderate or severe level by a pulmonologist according to GOLD criteria
• age range of 45-70 years
• BMI<30
• being literate
• having a strong understanding of the Persian language
• having a constant prescription drug regime
• not suffering from another serious and restrictive disease (such as major psychological disorder, neural disease, musca-skeletal disease, cancer, cardiac or angina attack in last month)

Exclusion Criteria

• hospitalization during the intervention
• need to use of oxygen or spray during 6-minute walking test
• dealing with serious stress
• failure of patient to attend personal or group education session
• non-compliance with a practical program that was determined at monthly visits for intervention group

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahvaz Jundishapur University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

maryam heidari

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

maryam heidari, M.sc

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.

Other Identifiers

P-327

Identifier Type: -

Identifier Source: org_study_id