Clinical trial NCT02567474: Effect of Self Management Program on Clinical Status of COPD Patients
Official title: Effect of Self Management Program Based on 5A Model on Clinical Status of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: chronic lung disease
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: dyspnea severity measured by dyspnea Borg scale
timeFrame: 3 month
Secondary outcomes:
measure: exercise tolerance rate
timeFrame: 3 month
measure: lung function status measured by spirometry
timeFrame: 3 month
measure: quality of life
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nursing, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.
name: maryam heidari, M.sc
role: PRINCIPAL_INVESTIGATOR
References: