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The effect of family-centered care model on health literacy level and sleep quality in patients after coronary artery bypass grafting

Protocol summary

Study aim
Determinig the effect of family centered care on health literacy and sleep quality in patients after CABG
Design
This study is a randomized clinical trial with intervention and control group.
Settings and conduct
This study will be done in alzahra cardiovascular hospital on 100 post CABG patients. Since intervention are supportive-educational and must be done by the researcher, therefore there is no possibility for blindness.
Participants/Inclusion and exclusion criteria
Participants in this study are patients after CABG surgery. inclusion criteria are reading and writing literacy, non-emergency CABG, no history of CABG and being able to make phone calls.
Intervention groups
Intervention group: Family centered care will execute for patients and the family member responsive for care of the patient in 3 educational 30-40 minutes sessions. First session will be done 24-48 h before surgery and general topics about the disease, the reason for the need for CABG and preparations needed before surgery will be presented. In the second session, 48 hours after surgery, group discussion in 4-6 person groups will be used. topics of this session will be presented at five parts: diet, drug regimen, activity plan, complications of surgery and cares needed after surgery. In the third session, which is 4th day after surgery, wound care methods, physical exercises, how to use varicose socks and sternum protector will be educated. After this session, participants follow up for one month, two times a week, with phone calls, and the process of implanting of presented care plan will be evaluated. forth session is one month after patient discharge, and in this session participants will complete study questionnaires again. Control group: Control group will receive only routine cares and the researcher will not do any intervention for them.
Main outcome variables
Sleep quality Health literacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130212012452N7
Registration date: 2018-05-05, 1397/02/15
Registration timing: retrospective

Last update: 2018-05-05, 1397/02/15
Update count: 0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Shahram Etemadifar
Name of organization / entity
Isfahan University of Medical Sciences, Fculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2969
Email address
etemadifar@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care model on health literacy level and sleep quality in patients after coronary artery bypass grafting
Public title
The effect of family-centered care model in patients after coronary artery bypass grafting
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the syudy Non-emergency surgery Reading and writing literacy Being able to make phone calls
Exclusion criteria:
history of coronary artery bypass graft surgery patients with chronic underlying disease such as chronic renal failure, CVA and COPD
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants to this study allocate to intervention and control group by picking up a draw. In order to do this job, the researcher made 100 card, which on 50 of them is written "1", and on 50 of the is written "2", and asks each participant to pick up one of these cards. If the patients pick up the card which is written "1", he or she allocates to the control group, and if the participant pick up the "2" card, he or she allocates to the intervention group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.SJUMS.REC.1396.179

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sleep quality score on Pittsburgh index
Timepoint
Before and one month after interventions
Method of measurement
Pittsburgh sleep quality index

2

Description
Health literacy score in Health literacy for adult questionaire
Timepoint
Before and one month after interventions
Method of measurement
Health literacy for adult questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: for intervention group, family centered care will execute for patients and the family member responsive for care of the patient in the form of 3 educational 30-40 minutes sessions. firs session is 24-48 hours before surgery. In this session, general topics about the disease, the reason for the need for CABG and preparations needed before surgery will be presented. In the second session, 48 hours after surgery, group discussion in 4-6 person groups (2-3 patients with one famly member for each) will be used. topics of this session will be presented at five parts: diet, drug regimen, activity plan, complications of surgery and cares needed after surgery. In the third session, which is 4th day after surgery, wound care methods, physical exercises, how to use varicose socks and sternum protector will be educated. After this session, participants follow up for one month, two times a week, with phone calls, and the process of implanting of presented care plan will be evaluated. forth session is one month after patient discharge, and in this session participants will complete study questionnaires again.
Category
Other

2

Description
Control group: Control group will receive only routine cares and the researcher will not do any intervention for them.To comply with the ethics of research, after the end of interventions and collecting post test data, all the educational topics used for intervention group, will be offered to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra cardiovascular hospital
Full name of responsible person
Zahra Abbasi
Street address
Alzahra cardiovascular hospital, Khatoon square, Sibouye Blvd
City
Shiraz
Province
Fars
Postal code
7164954937
Phone
+98 71 3735 5041
Email
zabbasi1070@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Kashani Street
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahram Eatamadifar
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani Street
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Fax
Email
sh_etemadifar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Shahram Etamadifar
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani Street
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Fax
Email
sh_etemadifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Abbasi
Position
Nursing Graduate Student
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and midwifery faculty, Shahrekord University of Medical Sciences, Rahmatiyeh
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 5648
Fax
Email
zabbasi1070@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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