Effect of Self Management Program on Clinical Status of COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567474
• Other study ID #: P-327
• Status: Completed
• Phase: N/A
• First received: September 27, 2015
• Last updated: October 2, 2015
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: October 2015
• Source: Ahvaz Jundishapur University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• 5 A model
self management program based on 5A model

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahvaz Jundishapur University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes