Protocol summary

Summary
The aim of this study was to investigate the effect of education on using peak flow meter based on asthma action plan on asthma control. The study is a quasi-experimental controlled trial. A total of 95 asthma patients, recruited from Shariati and Imam Khomeini pulmonary clinics in Tehran were randomly assigned into intervention or control group. The patients in the intervention group received two educational sessions that including asthma, peak flow meter and asthma action plan in the intervention group. The patients sent SMS about peak flow rate to researcher in a period of 12 weeks. Also, the researcher provided feedback to patients about their asthma control weekly. The patients in the control group did not receive education or peak flow meter. Asthma control test and asthma attack form were obtained before and after study (3 months) and compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105146472N1
Registration date: 2011-08-05, 1390/05/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-05, 1390/05/14
Registrant information
Name
Shadan Pedram Razi
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
pedramrazi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2010-04-30, 1389/02/10
Expected recruitment end date
2010-12-31, 1389/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education and follow-up using peak flow meter based on asthma action plan on asthma control
Public title
The effect of using peak flow meter based on asthma action plan on asthma control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-60 years old, having a confirmed diagnosis of asthma for at least six months, not having a severe or acute asthma disease, not having concurrent other chronic diseases such as: COPD, cystic fibrosis, severe rheumatoid arthritis, neoplasia, severe heart or kidney or liver disease, not having cognitive deficits or psychiatric co-morbidity, ability to read and speak Persian, having minimum literacy to read and understand text messages sent, having own mobile phones or in their close relatives, not having any sight problem or there is a third person for reading messages, not having asthma action plan based on peak flow meter Exclusion criteria: Admission in hospital for any reason during the study, relapse of severe or acute stage, not sending 9 consecutive messages
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences and Health Services
Street address
Tehran University of Medical Sciences and Health Services, Keshavarz Ave., Tehran, Iran
City
Tehran
Postal code
Approval date
2011-05-14, 1390/02/24
Ethics committee reference number
297/ 130/ ص/ 90

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
Asthma disease control
Timepoint
The first and 3 months after the study
Method of measurement
Asthma control test

Secondary outcomes

1

Description
Peak flow rate
Timepoint
3 times a week
Method of measurement
Peak flow meter based on asthma actin plan

Intervention groups

1

Description
Intervention group: two educational sessions. The first session was about asthma disease, also the patients were instructed to blow three times every morning and evening into a peak flow meter and recorded the best reading in peak expiratory flow chart. During two weeks, patients in intervention group measured peak expiratory flow values and recorded in their chart, also they sent one SMS to researcher about the best peak expiratory flow rate, three times in a week. After two weeks, second education session was held. This session was about education of asthma action plan. Then, the patients sent the SMS in a period of 12 weeks. Also, researcher provided feedback to patients about their asthma control, weekly.
Category
Treatment - Drugs

2

Description
Control group: not receiving education and peak flow meter
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Pulmonary clinic
Full name of responsible person
Shadan Pedram Razi
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Shariati hospital pulmonary clinic
Full name of responsible person
Shadan Pedram Razi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shadan Pedram Razi
Street address
Tehran University of Medical Sciences and Health Services, tehran, iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shadan Pedram Razi
Position
Teacher
Other areas of specialty/work
Street address
Medical-Surgical unit, Faculty of Nursing & Midwifery Tehran University of Medical Science and Health Services, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
pedramrazi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shadan Pedram Razi
Position
Teacher
Other areas of specialty/work
Street address
Medical-Surgical unit, Faculty of Nursing & Midwifery Tehran University of Medical Science and Health Services, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
pedramrazi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shadan Pedram Razi
Position
Teacher
Other areas of specialty/work
Street address
Medical-Surgical unit, Faculty of Nursing & Midwifery Tehran University of Medical Science, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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