Current study Experimental (RCT) is to determine the effect of applying continuous care model on sleep quality in patients with chronic heart failure. Patients are placed in two experimental and control groups.
Inclusion criteria included the following people older than 18 years old, patients with stable chronic heart failure, ejection fraction less than 45%, patients with NYHA class II-IV. Exclusion criteria: unwillingness to continue participation in the study, crisis or an unforeseen accident the patient had a history of psychiatric disorders, pregnant women patients with renal failure requires dialysis.
Research tools: Pittsburgh Sleep Quality Scale, and a questionnaire of personal information. Intervention: Implementation of continuous care model in the experimental group for three months is based on continuous care model. Continuous care model consists of four stages: orientation, sensitization, control and evaluation components. Data analysis using descriptive and inferential statistics (chi-square tests, t-test, regression, covariance analysis) will be performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010425843N1
Registration date:2016-04-03, 1395/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Hajar Sadeghi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
haj.sadeghi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying continuous care model on sleep quality in patients with stable heart failure
Public title
The effect of applying continuous care model on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: people older than 18 years old, patients with stable chronic heart failure, ejection fraction less than 45%, patients with NYHA class II-IV. Exclusion criteria: unwillingness to continue participation in the study, crisis or an unforeseen accident the patient had a history of psychiatric disorders, pregnant women patients with renal failure require dialysis.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
Approval date
2015-03-16, 1393/12/25
Ethics committee reference number
14-176-93
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
Quality of sleep
Timepoint
Before and after intervention
Method of measurement
Pittsburgh Sleep Quality Index(PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Pittsburgh Sleep Quality Index by the control group and the test is completed, follow-up care model consists of four phases: orientation, sensitization, control and evaluation of Pittsburgh measured in the test group .
Category
Behavior
2
Description
Control group: Control group received usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Hajar Sadeghi
Street address
Arak, Nurse Sq, Alamolhoda St, Amir kabir Hospital
City
Arak
2
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Hajar Sadeghi
Street address
Arak, Sardasht, Amiralmomenin hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Akram Moslemi
Street address
Arak University of Medical Sciences, Alamolhoda St., Rahahan Sq.
City
Arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSc, Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSc
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Arak University of Medical Sciences, Sardasht,
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hajar Sadeghi
Position
MSc, Faculty member
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Arak University of Medical Sciences, Sardasht
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
haj.sadeghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)