The aim of this randomized clinical trial with pre-test-post-test design is to investigate effect of two educational methods (Family-centered and patient-centered) on adherence to therapeutic regimen and some of complications during hemodialysis. Sixty hemodialysis patients 18 - 65 years old randomly will be assigned in two groups: patient -centered (N=30 on even days) and family-centered (N=30 on odd days). Some of inclusion criteria would be the patients with positive history of muscle cramps or hypotension two weeks before the intervention. The patient had neither history of cardiovascular problems nor consuming any anti-hypertensive drugs or history of musculoskeletal problems. The patients should not be in uremic phase. Patient’s primary care taker will have the highest participation in the treatment and should be able to read and write at least. Hypotension and muscle cramp will be assessed by use of check list in three stages (pre-test, 2 weeks and 4 weeks after intervention).peri-dialysis Hypotension would be checked (pre dialysis, first, second, third, four and final hour) and muscle cramps (mid and final half hour) as well. The adherence to therapeutic regimen will be evaluated by using researcher-made questionnaires once in before intervention and once in the fourth week after intervention. The results would be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204161599N17
Registration date:2014-04-16, 1393/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-16, 1393/01/27
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Nursing & Midwifery Care Research Center
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-07-19, 1391/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Family-centered and patient-centered teaching on adherence to therapeutic regimen and hemodialysis complications
Public title
Family-centered teaching vs patient-centered teaching on hemodialysis patient adherence of therapeutic regimen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 65 years old patients on hemodialysis three times a week and each time 3 to 4 hours of dialysis. The patients with positive history of muscle cramps or hypotension two weeks before the intervention. The patient had neither history of cardiovascular problems nor consuming any anti-hypertensive drugs or history of musculoskeletal problems. The patients should not be in uremic phase. Patient’s primary care taker will have the highest participation in the treatment and should be able to read and write at least. Exclusion criteria: 1- patients who are candidates for transplantation during the study. 2-patients who change nutrition or drug programs by physicians
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St. Tehran , Tehran, IR,Iran
City
Tehran
Postal code
1416614741
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
2454/130/د/90
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Hypotension
Timepoint
before dialysis, first, second, third, fourth and final hour of dialysis
Method of measurement
checklist
2
Description
muscle cramps
Timepoint
in middle and final half-an-hour of dialysis
Method of measurement
checklist
3
Description
adherence to therapeutic regimen
Timepoint
once before intervention and once in the fourth week after intervention
Method of measurement
researcher-made questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention patient-centered education: The researcher trains the patient’s four meetings, 30-45 minutes of training as face to face training. The end of each meeting will be relevant educational pamphlet.
Category
Prevention
2
Description
Intervention family-centered education: The researcher trains the patient along with patient’s primary care taker four meetings, 30-45 minutes of training as face to face training. The end of each meeting will be relevant educational pamphlet
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parvaneh Asgari
Street address
Nosrat St., Tohid Sq.,Imam Khomeini Hospital, Tehran, IR Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods St., Keshavarz BLVD, 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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
Ms Degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq.,Tehran University of Medical Science, Tehran, Iran
City
Tehran
Postal code
1416614741
Phone
+98 21 8896 8862
Fax
Email
p_marjan@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mitra Zolfaghari
Position
Assistant professor of Virtual School.
Other areas of specialty/work
Street address
Virtual School, Tehran University of Medical Sciences, Dolatshahi All., Naderi St., Keshavarz BLVD, Tehran. Iran.
City
Tehran
Postal code
1416614741
Phone
+98 21 8897 8088
Fax
Email
zolfaghm@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
Ms Degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat St., Tohid Sq.,Tehran University of Medical Science, Tehran, IR Iran
City
Tehran
Postal code
982347654524
Phone
+98 21667198
Fax
Email
P_Marjan@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)