NCT02567474

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

September 27, 2015

Last Update Submit

October 2, 2015

Conditions

Keywords

chronic lung disease

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 INTERVENTION

no intervention

intervention

EXPERIMENTAL

self management intervention based on 5A model

Behavioral: 5 A model

Interventions

5 A modelBEHAVIORAL

self management program based on 5A model

Also known as: self managment
intervention

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • maryam heidari, M.sc

    Department of Nursing, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.

    PRINCIPAL INVESTIGATOR

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