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Clinical Trials/NCT02567474
NCT02567474CompletedNot Applicable

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

Ahvaz Jundishapur University of Medical Sciences0 sites50 target enrollmentStarted: November 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
dyspnea severity measured by dyspnea Borg scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
45 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • certified diagnosis of COPD with moderate or severe level by a pulmonologist according to GOLD criteria
  • age range of 45-70 years
  • 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

Outcomes

Primary Outcomes

dyspnea severity measured by dyspnea Borg scale

Time Frame: 3 month

dyspnea was measured by dyspnea Borg scale. This scale is visual tool ranging from 0(not dyspnea) to 10(maximum dyspnea).

Secondary Outcomes

  • quality of life(3 month)
  • lung function status measured by spirometry(3 month)
  • exercise tolerance rate(3 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

maryam heidari

principal investigator

Ahvaz Jundishapur University of Medical Sciences

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