Effect of Self Management Program on Clinical Status of COPD Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Behavioral: 5 A model

• Registration Number: NCT02567474
• Lead Sponsor: Ahvaz Jundishapur University of Medical Sciences

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).

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Study First Submitted: 2015-09-27
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-02
• Last Update Submitted: 2015-10-02
• Study First Posted: 2015-10-05
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	5 A model	self management intervention based on 5A model

Primary Outcome Measures

Name	Time	Method
dyspnea severity measured by dyspnea Borg scale	3 month	dyspnea was measured by dyspnea Borg scale. This scale is visual tool ranging from 0(not dyspnea) to 10(maximum dyspnea).

Secondary Outcome Measures

Name	Time	Method
quality of life	3 month	quality of life was measured by SF-36 Questionnaire. It consisted of 36 questions that examine the eight quality of life dimensions, each question has a continuous quantitative scale from 0 to 100, in which higher scores indicate better situation.
lung function status measured by spirometry	3 month	lung function was measured by spirometry. Spirometry is a test that measures how an individual inhales or exhales volumes of air as a function of time
exercise tolerance rate	3 month	exercise tolerance was measured by Six Minutes Walking Test.in this test the distance that each patient was able to walk under standard condition in 6 minutes was measured by researchers.