Effect of Self Management Program on Clinical Status of COPD Patients
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedOctober 5, 2015
October 1, 2015
5 months
September 27, 2015
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
exercise tolerance rate
3 month
lung function status measured by spirometry
3 month
quality of life
3 month
Study Arms (2)
control
NO INTERVENTIONno intervention
intervention
EXPERIMENTALself management intervention based on 5A model
Interventions
self management program based on 5A model
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
maryam heidari, M.sc
Department of Nursing, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 27, 2015
First Posted
October 5, 2015
Study Start
November 1, 2012
Primary Completion
April 1, 2013
Study Completion
June 1, 2013
Last Updated
October 5, 2015
Record last verified: 2015-10