Effect of health-promotion behaviors education versus no education on the quality of life in hemodialysis patients: a before after randomized clinical trial
Objectives: To assess the effect of health-promotion behaviors education versus no education on the quality of life in hemodialysis patients.
Design: a before after randomized clinical trial.
Setting and conduct: The eligible hemodialysis patients who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) being dialyzed for at least 6 months; (b) not having any chronic diseases including high blood pressure, diabetes, and malignancy; (c) age of 18 to 60 years.; (d) ability of verbal communication and not having any psychological disorder or fictional disability; (e) literate; (f) being dialyzed for two or three times a week.
Exclusion criteria: (a) moving to another center and not returning due to death or medical reasons; (b) participating in a similar research concurrently.
Intervention: Receiving an educational booklet plus face to face health-promotion behaviors education, 6 sessions for 30 minutes during 3 consecutive weeks
Control: Receiving an educational booklet only.
Primary outcome: Measuring the quality of life before and 3 months later using Ferrans & Powers standard questionnaire.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505109014N62
Registration date:2015-05-17, 1394/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-03-03, 1393/12/12
Expected recruitment end date
2016-03-02, 1394/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of health-promotion behaviors education versus no education on the quality of life in hemodialysis patients: a before after randomized clinical trial
Public title
Effect of health-promotion behaviors education versus no education on the quality of life in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) being dialyzed for at least 6 months; (b) not having any chronic diseases including high blood pressure, diabetes, and malignancy; (c) age of 18 to 60 years.; (d) ability of verbal communication and not having any psychological disorder or fictional disability; (e) literate; (f) being dialyzed for two or three times a week.
Exclusion criteria: (a) moving to another center and not returning due to death or medical reasons; (b) participating in a similar research concurrently.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: One of the two hospitals will be randomly selected as intervention group and the other one as the control group. Therefore, the trial will be run as single blind trial.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
D/P/16/35/9/5862
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Measuring the quality of life
Timepoint
before and 3 months later
Method of measurement
using Ferrans & Powers standard questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Receiving an educational booklet plus face to face health-promotion behaviors education, 6 sessions for 30 minutes during 3 consecutive weeks
Category
Lifestyle
2
Description
Receiving an educational booklet only
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Sahar Zonoori
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Shahid Beheshti Hospital
Full name of responsible person
Sahar Zonoori
Position
Nursing Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
sahar.zonoori662005@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Seyyed Reza Borzou
Position
PhD in Nuring Education
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
borzou@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Hamadan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)