Comparing the effect of telephone and text messaging follow ups of empowerment program on quality of life and fatigue of people with chronic obstructive pulmonary disease(COPD)
Comparing the effect of telephone and text messaging follow ups of empowerment program on quality of life and fatigue of people with chronic obstructive pulmonary disease
Design
Three arm parallel group, blinded randomized trial with control group and sample size of 105 People. Randomisation will centralize and computerize with concealed randomization sequences carried out at an external site.
Settings and conduct
After entering the samples to study and spending 6 sessions of empowerment programi in HajarHospital of Shahrekord, patients will randomly assigned to one of three groups of follow-up, telephone, SMS and control. follow-ups will be conducted twice a week in the first month and once in the second and third months.The control group will receive only routine care.Blindness will also be in the form of data collection by someone other than the researcher.
Participants/Inclusion and exclusion criteria
inclusion:
clinical diagnosis of COPD grade 2 and 3 according to the GOLD
criteria،Willingness to participate in the study،Ability to speak and communicate and ،Able to Read and write ،Having a mobile phone ،Able to use SMS service ،No enrolled in other empowerment programs during the past 6 months،No history of mental disorder according to medical record and physician's opinion
exclusion:
Unwillingness to participate in the study، Diseases that make the patient's condition unstable
Intervention groups
Intervention group1: Telephone follow-up by calling to patient by researcher for the first month twice a week and for the second and third months, once.
Intervention group2: SMS follow-up,-prepared SMS will sent to the patient by researcher two days a week and then once a week for the second and third months.
The control group :receive only routine care.
Main outcome variables
quality of life,
fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170122032101N4
Registration date:2020-04-06, 1399/01/18
Registration timing:retrospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Haydeh Heidari
Name of organization / entity
Medical University
Country
Iran (Islamic Republic of)
Phone
+98 33346699
Email address
heidari.h@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-05, 1398/06/14
Expected recruitment end date
2019-12-05, 1398/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of telephone and text messaging follow ups of empowerment program on quality of life and fatigue of people with chronic obstructive pulmonary disease(COPD)
Public title
Comparing the effect of telephone and text messaging follow ups in chronic obstructive pulmonary disease(COPD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of COPD
Grades 2 and 3 of COPD according to the GOLD criteria
Willingness to participate in the study
Ability to speak and communicate
Having Reading and writing skills
Having a mobile phone
Ability to use SMS service
having at least 40 years of age
No enrolled in other empowerment programs during the past 6 months
No history of mental disorder according to medical record and physician's opinion
Exclusion criteria:
Diseases that make the patient's condition unstable
Unwillingness to participate in the study
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
by using the random number table
The numbers 1-105 prepared in the sixth session of each group are divided so that each person has a unique number.after the empowerment for all patients, each individual enters one of three groups according to the random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
It is not possible for the patient to be blinded but for blinding, someone Except the researcher will collect data
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
ethics committee, University Headquarters, Kashani Blv, Shahrekord city, cheharmal va bakhtiari
Other specified chronic obstructive pulmonary disease
Primary outcomes
1
Description
quality of life
Timepoint
Before empowerment sessions and before and after intervention
Method of measurement
St George's Questionnaire
2
Description
fatigue
Timepoint
Before empowerment sessions and before and after intervention
Method of measurement
The Piper Fatigue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Telephone follow-up: the researcher contact with the patientby using telephone twice a week for the first month , and for the second and third months, once a week, from 8 am to 8 pm, for 18-15 minutes depending on patient desire.At each meeting the content of the conversation is recorded by the researcher to evaluate the status of the achievement in subsequent calls.If the question is out of the nurse's knowledge, the nurse will inform the physician after consultation with the physician.
Category
Other
2
Description
Intervention group: text messaging follow up: The text prepared by the researcher is sent to the patient twice a week and then once a week for the second and third months.Patients are asked to send a confirmation message to the researcher after viewing the text, and the patient can ask his/her questions. SMS charges will be charged by the gift SMS service if the patient's line is Irancell and for the other operators a gift charge will be send .
Category
Other
3
Description
Control group: They receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Haydeh Heidari
Street address
Kashani hospital, Parastar Ave, Shahrekord city, cheharmahal va bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3333 6699
Fax
+98 38 3334 6714
Email
haydehheidari@gmail.com
2
Recruitment center
Name of recruitment center
hajar hospital
Full name of responsible person
Haydeh Heidari
Street address
Hajar hospital, Parastar Ave, Shahrekord city, cheharmahal va bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814814776
Phone
+98 38 3222 0016
Email
haydehheidari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
University Headquarters, Kashani Blv, Shahrekord city, cheharmal va bakhtiari
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814814776
Phone
+98 38 3333 6699
Fax
+98 38 3334 6714
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Haydeh Heidari
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord Medical University, Rahmatie ,SHahrekord city,cheharmahal va bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814814776
Phone
+98 33346699
Fax
Email
heidari.h@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Haydeh Heidari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord Medical University, Rahmatie ,SHahrekord city,cheharmahal va bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871633411
Phone
+98 33346699
Fax
Email
heidari.h@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Haydeh Heidari
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord Medical University, Rahmatie ,SHahrekord city,cheharmahal va bakhtiari
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871633411
Phone
+98 33346699
Fax
Email
heidari.h@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available