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Comparison of the effectiveness of rehabilitation through the home visit and telephone follow up on self-efficacy in coronary artery bypass graft patients and their family caregivers' burden.

Protocol summary

Study aim
Comparison of the effectiveness of rehabilitation through home visit and telephone follow up of patients with coronary artery bypass graft surgery and their family caregivers' burden
Design
Patients with coronary artery bypass surgery and their caregivers, control group, home visit and follow-up, randomized blocking, and placement in blocks, sample size of each group 40 with a probability of 10% dropping 44 in each group during discharge
Settings and conduct
Before and after clinical trials, patients with coronary artery bypass graft surgery, Khorramabad Heart Center, and their families, after satisfaction completed questionnaires, visit group, 1 weekly visit, 2 times weekly follow up Four weeks, at the end, questionnaires were completed in the last visit, in the other two groups completed the questionnaire by visiting the home
Participants/Inclusion and exclusion criteria
Inclusion criteria Patients: 70 to 30 years The absence of mental or psychomotor disorder caregiver: Have a reading and writing literacy Exit criteria Patients: Having known psychomotor disorder caregiver: Aged 18 and over
Intervention groups
The intervention group 1: Home visit: completion of a questionnaire during discharge, delivery of booklet, one day after discharge, then weekly visit at home four weeks, completing the questionnaires Intervention group 2: Telephone follow up, completion of a questionnaire during discharge, delivery of booklet, one day after discharge, then two times weekly telephone training, referral to home in last session of fourth week, completion of questionnaires Control group: completion of questionnaire during discharge, provision of routine to the patient, referral to home during last session of fourth week, completion of questionnaires
Main outcome variables
Self-efficacy of patients; family burden caregivers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100609004129N2
Registration date: 2018-11-11, 1397/08/20
Registration timing: registered_while_recruiting

Last update: 2018-11-11, 1397/08/20
Update count: 0
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
Shirin Hasanvand
Name of organization / entity
Lorestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66 1321 3759
Email address
hasanvand.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-27, 1397/04/06
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of rehabilitation through the home visit and telephone follow up on self-efficacy in coronary artery bypass graft patients and their family caregivers' burden.
Public title
The effect of rehabilitation on the effectiveness of coronary artery bypass graft surgery patients and their caregivers' burden.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing coronary artery bypass graft surgery Familiarity with Persian language, Laki and accent Lori The absence of mental or psychomotor disorder The absence of hearing impairment, vision, speech, The absence of chronic disease disability Access to fixed telephony Having a caregiver available during admission Aged 18 and over(caregiver ) Have a reading and writing literacy (caregiver )
Exclusion criteria:
previous record of participation in cardiac rehabilitation programs The incidence of the disease Systemic The incidence hemodynamic disorder Literacy is not read and write (caregiver ) Having known psychomotor disorder (caregiver )
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
The studied units (patient and caregiver) will be assigned to the three groups according to the criteria for inclusion in the study and available on the basis of randomized blocking. The entry of individuals to each of the groups will be done in the order of the number of selected blocks and will be done using the layout inside the block.
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 lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaie Square, Moaalem St
City
Khorramabad
Province
Lorestan
Postal code
6819833895
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.LUMS.REC.1397.027

Health conditions studied

1

Description of health condition studied
self-efficacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
patient Self-efficacy
Timepoint
During discharge from the hospital one month after the discharge
Method of measurement
Joker Questionnaire

Secondary outcomes

1

Description
Caregivers burden, family Caregivers
Timepoint
During the discharge of the hospital and completion of the intervention up to 4 weeks after discharge
Method of measurement
Novak and Gest Questionnaire

Intervention groups

1

Description
Intervention group 1: Visit at home with the presence of a nurse in coordination with the patient's home and assess and train her for 4 weeks, weekly 1 time (4 sessions each), and each time for about an hour, from the first day after discharge. Complete the patient's questionnaire and care and delivery of the Educational booklet, patient counseling and family about the lifestyle modification including risk management, assessment of sleep status, nutrition, appetite and excretion, drug use and drug complications, mood and mental state of the patient, stopping use Smoking, wound care, referral to doctor, personal hygiene, bathing, sex work, traveling, driving, prayer Dan, climbing stairs, pressure, and blood sugar control is carried out, at the end of the rehabilitation program, during the last visit, this will be questionnaires completed by patients and caregivers.
Category
Rehabilitation

2

Description
Intervention group2 : Telephone follow up, telephone training and counseling based on the 2 weekly rehabilitation program for 4 weeks (totaling 8 telephone calls) and each call approximately 30 minutes from the first day after discharge by completing the patient and caregiver questionnaire and delivering the educational booklet. , And counseling and training, such as a home visit group, and completing questionnaires on the last day of the 4th week with the researcher's visit to the home.
Category
Rehabilitation

3

Description
Control group: From the first day of discharge after the discharge, by completing the patient and caregiver questionnaire, according to the routine of the treatment center during the discharge of the patient from the hospital, the training was provided by providing the hospital training package and completed the questionnaire on the last day of the 4th week The researcher will go home.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Shirin Hasanvand
Street address
Shaheed Madani Hospital, Imam Hossein Square, Kheirabad
City
Khorramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3341 9123
Fax
+98 66 3341 9125
Email
goharif52@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morvat Taheri Kalani
Street address
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaie Square, Moaalem Street
City
Khorramabad
Province
Lorestan
Postal code
6819833895
Phone
+98 66 3312 0158
Email
goharif52@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr Shirin Hasanwand
Position
Ph.D. in Nursing, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ground floor, Danesh 5th Alley, Danesh Street, Sepahan St., 60meter Street
City
Khorramabad
Province
Lorestan
Postal code
6819833895
Phone
+98 66 3341 9023
Email
goharif52@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr Shirin Hasanwand
Position
Ph.D. in Nursing, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ground floor, Danesh 5th Alley, Danesh Street, Sepahan St., 60meter Street
City
Khorramabad
Province
Lorestan
Postal code
6819833895
Phone
+98 66 3341 9123
Email
hasanvand.sh1390@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Forouzan Gohari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ground floor, Danesh 5th Alley, Danesh Street, Sepahan St., 60meter Street
City
Khorramabad
Province
Lorestan
Postal code
6819833895
Phone
+98 66 3341 9123
Fax
+98 66 3341 9125
Email
goharif52@yahoo.com
Web page address

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
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
Undecided - It is not yet known if there will be 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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