Protocol summary

Summary
This is a quasi-experimental before after study. Simple random Sampling did from hemodialysis ward patients at Motahari hospital in Jahrom, 2014. Samples were 40 patients in 5 groups. Consent form accepts from patients and their families. Quality of life (KDQOL-SFTM), quality of sleep (Pittsburg sleep questionnaire) and quality of dialysis (kt/v & URR) in 4 phases calculated. Assess 2 phases before intervention (1 month before intervention- immediately before intervention). Then Continues care model implement in 1 month and in 4 stages, 1st stage: introduction, 2nd stage: sensation, 3th stage: control & 4th stage: evaluation. Then assess all 3 factors immediately after intervention and 1 month after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015020419566N3
Registration date: 2015-02-17, 1393/11/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-17, 1393/11/28
Registrant information
Name
Mohsen Hojat
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 715433054
Email address
hojat@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementing continuous care model on life quality, sleep quality and dialysis quality of hemodialysis patients: a clinical trial
Public title
Effect of implementing continuous care model on life quality, sleep quality and dialysis quality of hemodialysis patients: a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients' willing to take part in the study; full orientation and good general condition. Exclusion criteria: dying during the study and unwilling to participant in study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
1392-124

Health conditions studied

1

Description of health condition studied
Renal failure
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
Quality of life
Timepoint
1 month before intervention, immediately before intervention; immediately after intervention and 1 month after intervention
Method of measurement
(KDQOL-SFTM) kidney disease quality of life

Secondary outcomes

1

Description
Sleep quality
Timepoint
1 month before intervention, immediately before intervention; immediately after intervention and 1 month after intervention
Method of measurement
Pitsburg sleep quality questionnaire

2

Description
Quality of dialysis
Timepoint
1 month before intervention, immediately before intervention; immediately after intervention and 1 month after intervention
Method of measurement
kt/v, urr

Intervention groups

1

Description
1 group befor and after intervention from 3 indicators assessed. implementation of 4 stage of continuous care model Then Continues care model implement in 1 month and in 4 stages, 1st stage: introduction, 2nd stage: sensation, 3th stage: control & 4th stage: evaluation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom Motahari hospital
Full name of responsible person
Mahdi Karimiar
Street address
Jahrom Motahari hospital, Motahari avenue, Jahrom-fars-iran
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Kavos Solhjo
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member, PhD student of nursing
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
Phone
+98 71 5431 5034
Fax
Email
mohsenhojat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member- PhD student
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
Phone
+98 715431503
Fax
Email
mohsenhojat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Mohsen Hojat
Position
Faculty member, PhD student of nursing
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
7418683195
Phone
+98 71 5426 0608
Fax
Email
mohsenhojat@yahoo.com
Web page address
www.jums.com

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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