Determining the effect of follow-up care on quality of life in hemodialysis patients referring to hospitals in Hamedan
Design
In this research, 60 eligible patients referring to hemodialysis center will be chose purposefully. Then, patients randomly will be divided into two control and intervention groups.
Settings and conduct
The intervention will include telephone follow up and training related to hemodialysis patients based in Besat Hospital. The texting follow-up content is provided by the research team on the basis of authoritative scientific references in this area. Telephone follow up will be done within 6 consecutive weeks , so that the researcher at least 6 weekly texts in Persian will be up to 160 letters in relation to the treatment acceptance behaviors associated with quality of life (diet, exercise And physical activity, drug regimen and ...).
Participants/Inclusion and exclusion criteria
Inclusion criteria : Having informed consent to enter the study; mobile access and ability to speaking
Exclusion criteria : Failure to receive SMS more than two consecutive times and death.
Intervention groups
Telephone follow up will be done within 6 consecutive weeks , so that the researcher at least 6 weekly texts in Persian will be up to 160 letters in relation to the treatment acceptance behaviors associated with quality of life (diet, exercise And physical activity, drug regimen and ...).
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N8
Registration date:2018-02-10, 1396/11/21
Registration timing:registered_while_recruiting
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2019-01-10, 1397/10/20
Trial completion date
empty
Scientific title
The effect of telephon follow up care on quality of life in hemodialysis patients.
Public title
Effect of telephon follow up care on quality of life in patient
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to enter the study
Having Mobile access and speaking ability
Three months passed from the onset of dialysis.
Exclusion criteria:
Failure to receive SMS more than two consecutive times
Deaths of hemodialysis patients
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the permutation block method.
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
Research Ethics Committee of Hamadan Universirt of Medical Sciences
Street address
Hamadan University of Medical Sciences,Hamadan
City
Hamdan
Province
Hamadan
Postal code
38698-65178
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.UMSHA.REC.1396.569
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Quality of life
Timepoint
before and after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Telephone follow up will be done within 6 consecutive weeks (36), so that the researcher will study at least 6 SMS in Persian for up to 160 letters each week in connection with the treatment acceptance behaviors associated with quality of life (diet, exercise And physical activity, drug regimen and ...).
Category
Lifestyle
2
Description
Control group: There will be no intervention in the control group except for routine care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Besaat Medical Center of Hamedan
Full name of responsible person
Reza Borzou
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0150
Email
Borzou@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Manoochehr Karami
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3383 0150
Email
Borzou@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3383 0150
Email
Borzou@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Borzou
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81338310150
Email
borzou@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instractor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh street, Hamadan University of Medical Science , Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3422 5056
Email
M.molavi@umsha.c.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