Effect of telephone follow-up methods and group session on quality of life of patients with pacemaker in clinic Investment, Chamran Hospital in Isfahan
The purpose of this study was to assess the effect of telephone follow up and group session on different domain of quality of life in patient with pacemaker. The inclusion criterias were the age between 18-85 and the first time implanation and the exclusion criteria was Lack of consent to continue participating in the study. This was a prospective quasi experimental study that covered 60 patient divided into three groups. For 20 patient in intervention group 4 group session were performed one day a week, each session would last 20-40 min. For 20 patient in telephone follow up 12 phone calling were performed for 4 weeks, each call would last 20 min, control group received the routine intervention as a educational material. The data were collected through" AQOL" for physical status and the quality of life questionaries. Physical status and quality of life were evaluated after one month intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805132289N1
Registration date:2011-06-25, 1390/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-25, 1390/04/04
Registrant information
Name
Fateme Aliakbari
Name of organization / entity
Nursing Midwifery School
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 4912
Email address
aliakbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2007-07-25, 1386/05/03
Expected recruitment end date
2008-02-28, 1386/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of telephone follow-up methods and group session on quality of life of patients with pacemaker in clinic Investment, Chamran Hospital in Isfahan
Public title
Effect of telephone follow-up methods and group session on quality of life of patients with pacemaker in clinic Investment ,Chamran Hospital in Isfahan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients are aged 18-80 years; are of both sexes; complete the individual consciousness, awareness of time, place and person possible Drmtalh companies have; For the first time pacemaker is embedded; Patients who have the ability to participate in the meetings are; have a telephone at home; mental disorder is not known in this field do not use drugs; speech and hearing problems are not known; during pregnancy and lactation not; surgery, while there is no pacemaker fitted; or physical mental disability which prevents the ability not participate in session.
Exclusion criteria: patient's unwillingness to continue participating in the study
Age
From 18 years old to 85 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Aliakbari
Secondary trial Id
386352
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Hezarjrib street, Midwifery Dept, Nursing and Midwifery Faculty, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2007-09-23, 1386/07/01
Ethics committee reference number
386352
Health conditions studied
1
Description of health condition studied
Pacemaker Implatation
ICD-10 code
Y83.1
ICD-10 code description
Surgical operation with implant of artificial internal device
Primary outcomes
1
Description
Quality of life
Timepoint
One month
Method of measurement
SF-36 questionaries
Secondary outcomes
1
Description
Physical condition
Timepoint
one month
Method of measurement
AQOL questionaries
Intervention groups
1
Description
For 20 patient in telephone follow up 12 phone calling were performed for 4 weeks, each call would last 20 min.
Category
Other
2
Description
For 20 patient in group session group 4 group session were performed one day a week, each session would last 20-40 min.
Category
Other
3
Description
For 20 patient in control group the routine intervention(giving educational material) was done.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital, Pace implatation clinic
Full name of responsible person
Street address
Salman-e Farsi street, Pace implatation clinic, Chamran Hospital, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Research Assistant
Street address
Hezarjrib street, Research Assistant, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Peyman Adibi
Street address
Hezarjrib street, Research Assistant, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
Proportion provided by this source
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
Isfahan University of Medical Science
Full name of responsible person
Aliakbari Fateme
Position
Student
Other areas of specialty/work
Street address
Hezarjrib street, Midwifery Dept, Nursing and Midwifery Faculty, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 38 1334 4912
Fax
Email
aliakbari@nm.mui.ac.iraliakbari@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty member
Full name of responsible person
Khalifezade Asghar
Position
Instructor
Other areas of specialty/work
Street address
Hezarjrib street, Midwifery Dept, Nursing and Midwifery Faculty Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1792 2901
Fax
Email
Khalifezadeh@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical of Science
Full name of responsible person
Khalifezade Asghar
Position
Faculty member
Other areas of specialty/work
Street address
Hezarjrib street, Midwifery Dept, Nursing and Midwifery Faculty, Univ of Medical Science, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1792 2901
Fax
Email
Khalifezadeh@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)