Protocol summary

Summary
This clinical trial study was done on patients admitted for valve replacement surgery. Inclusion criteria included; Having literacy of reading and writing, Lack of speech and hearing problems, Possible access to telephone and mobile phone (ability to use short massage by the patient or the closest person to him/her, Cardiac valve replacement surgery for the first time and age between 15 and 75 years old. Samples were chosen before surgery according to inclusion criteria by convenience sampling (based on target) and after written consent. They were in three groups of telephone-care follow-up, Short message follow-up and control in the form of random allocation (ball bag). Totally in this study 99 people were assessed (Thirty three people in telephone follow-up group, Thirty three people in short message follow- up group and thirty three people in control group). One booklet was given to all the three groups before discharge and with the content which was derived from the booklet; Education was given with the presence of the samples. In the telephone follow-up group, there was call contact in the first month two times per week,and in the second and third months one time per week before noon. In the short message follow-up group, one message had been sent daily before noon. There was no follow-up in control group.in this study patient’s quality of life assessed by Nottingham quality of life questionnaire before and 3 months after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031212797N1
Registration date: 2013-08-19, 1392/05/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-19, 1392/05/28
Registrant information
Name
Fateme Ghafori
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 1225
Email address
rbt@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of follow-up care by telephone and short massage services on patients' quality of life after cardiac valve replacement surgery
Public title
The effect of follow-up care by telephone and short massage services on patients' quality of life after cardiac valve replacement surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; 1. Lack of suffering progressed form of diseases of vital organs (Motor disability, Rheumatoid Arthritis, Stroke and etc…) and psychopathy (Schizophrenia, Psychosis, Depression and… ), 2. Having literacy of reading and writing, 3. Lack of speech and hearing problems, 4. Possible access to telephone and mobile phone (ability to use short massage by the patient or the closest person to him/her, 5. Cardiac valve replacement surgery for the first time, 6. age between 15 and 75 years old. exclusion criteria ; 1. Sample’s unwillingness to cooperate at any stage of the research, 2. Appearance of physical and mental problems that lead to patient’s disability at any stage of the research.
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 99
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
Baqiyatallah University of Medical Sciences Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran
City
Tehran
Postal code
Approval date
2011-11-29, 1390/09/08
Ethics committee reference number
28

Health conditions studied

1

Description of health condition studied
Heart Valve Disorders
ICD-10 code
I39*
ICD-10 code description
Endocarditis and Heart valve Disorders in Diseases Classified Elsewhere

Primary outcomes

1

Description
Quality of Life
Timepoint
Before surgery, Three months after surgery
Method of measurement
Nottingham Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Short message Intervention: One message had been sent daily.
Category
Other

2

Description
Telephone Intervention: There was call contact in the first month two times per week,and in the second and third months one time per week.
Category
Other

3

Description
Control group : No follow - up.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Street address
Baqiyatallah Hospital, Mollasadra Street, Tehran, Iran
City
Tehran

2

Recruitment center
Name of recruitment center
Jamaran Hospital
Full name of responsible person
Street address
Jamaran Hospital, Jamaran Street, Tehran, Iran
City
Tehran

3

Recruitment center
Name of recruitment center
Shahid Rajayee Center
Full name of responsible person
Street address
Shahid Rajayee Center, Vali-asr Street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, 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
Vice chancellor for research of Baqiyatallah University of Medical Sciences
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
Baqiyatallah University of Medical Sciences
Full name of responsible person
Fateme Ghafori
Position
MSc.
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8861 4010
Fax
Email
fatemeghafor@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Mahdi Sadeghi Sherme
Position
MSc.
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8861 4010
Fax
Email
rbt@bmsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Fateme Ghafori
Position
MSc.
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Mollasadra Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8861 4010
Fax
Email
fatemeghafor@yahoo.com
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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