Effect of Self Management Program on Clinical Status of COPD Patients

Effect of Self Management Program Based on 5A Model on Clinical Status of Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Behavioral: 5 A 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; no intervention
Experimental: intervention; self management intervention based on 5A model	Behavioral: 5 A model; self management program based on 5A model; Other Names: self managment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exercise tolerance rate	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.	3 month
lung function status measured by spirometry	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	3 month
quality of life	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.	3 month

Collaborators and Investigators

• Sponsor: Ahvaz Jundishapur University of Medical Sciences
• Investigators: Principal Investigator: maryam heidari, M.sc, Department of Nursing, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 27, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: chronic lung disease
• Other Study ID Numbers: P-327