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Completed

NCT Number: NCT02567474

Effect of Self Management Program on Clinical Status of COPD Patients

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5 A model

Behavioral

self management program based on 5A model

Other names: self managment

Primary outcomes

  1. 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

  1. exercise tolerance rate

    Time frame: 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.

  2. lung function status measured by spirometry

    Time frame: 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

  3. quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ahvaz Jundishapur University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2015
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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