Determining the effect of home-centered education on family caregivers' caring burden and incidence of bed sore in patients with discharge stroke
Design
In this study, 70 patients with a stroke who have entered the study are randomly divided into two groups of intervention and control and each participant is given a special code.
Settings and conduct
A study on stroke patients and their carers in Imam Ali hospital in Zahedan.
Participants/Inclusion and exclusion criteria
Patient login criteria:
1. The patient has no symptoms of bed sore or skin disorders at the start of the study.
2. Patients with a Brad's benchmark score of less than 14 in their baseline scores.
3- Stay in Zahedan.
4- Age 45 to 75 years.
Patient exit criteria:
1- Readmission or death of the patient during the study period.
2- To take the patient to the care centers.
3- Skin disease during the study.
4. Having suspicious wounds.
Family Career Entry Criterion:
1. Age over 18 years.
2. Be careful of the main responsibility of the patient.
3. Having reading and writing skills.
4- Residing in the city of Zahedan.
5. The absence of other family members, the maintenance of a mental illness or elderly in the family.
Family Care Exit Criteria:
1- Absence of more than 1 session of training sessions.
2- The occurrence of any burden stress incident for the caregiver during the study.
Intervention groups
In the control group, the questionnaires were then taken to the patient's address and call number again. After 12 weeks, no intervention was given to the patient and the caregiver to receive the post-test. The intervention group filled out the questionnaire from the caregiver and the patient. Then the intervention was given as 3 sessions of 1 week interval. In the case of stroke, subcutaneous wound, anxiety control, after 12 weeks of post-test.
Main outcome variables
Prevent bed sores and attendant care burden
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20171105037236N4
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
askarihas77@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-06-09, 1397/03/19
Actual recruitment start date
2017-10-22, 1396/07/30
Actual recruitment end date
2018-06-09, 1397/03/19
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The effect of home-based training on the incidence of pressure ulcer and family caregiver`s of burden patients discharged with stroke
Public title
Home-centered teaching of stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patient login criteria: 1. The patient has no symptoms of bed sore or skin disorders at the start of the study. 2. Patients with a Brad's benchmark score of less than 14 in their baseline scores. 3- Stay in Zahedan. 4- Age 45 to 75 years.
Family Career Entry Criterion: 1. Age over 18 years. 2. Be careful of the main responsibility of the patient. 3. Having reading and writing skills. 4- Residing in the city of Zahedan. 5. The absence of other family members, the maintenance of a mental illness or elderly in the family.
Exclusion criteria:
Patient exit criteria: 1- Readmission or death of the patient during the study period. 2- To take the patient to the care centers. 3- Skin disease during the study. 4. Having suspicious wounds
Family Care Exit Criteria: 1- Absence of more than 1 session of training sessions. 2- The occurrence of any burden stress incident for the caregiver during the study.
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
More than 1 sample in each individual
Number of samples in each individual:
2
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
this way, red cards (intervention) and control cards (prefixes) will be pre-numbered and randomly ordered.
Then, with the choice and gradual entry of patients and caregivers to study, each of the above-mentioned cards will determine the allocation of the group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahadan university of medical sciences
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
ir.zaums.rec.1396287
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality Of Life
Timepoint
Before And 12 Weeks After Intervention
Method of measurement
Zarit's Care Load Questionnaire, Braden's Wound Burden Risk Evaluation Score
Secondary outcomes
1
Description
Recurrent stroke
Timepoint
3 months later
Method of measurement
Individual medical records
Intervention groups
1
Description
Intervention group: 3 training sessions on bed stroke and lowering of care burden in the form of a hospital discharge day meeting and two sessions at a weekly interval at the patient's home and at the hospital.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital Zahedan
Full name of responsible person
Hasan Askari
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan Sistan And Baluchestan Iran,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5572
Fax
+98 54 3329 5572
Email
askarihas77@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nor Muhammad Bakhsani
Street address
University of Medical Sciences and Health Services, Zahedan University of Medical Sciences, Dr. Hesabi - Persian Gulf Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhsani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Zahedan - Fellowship
City
Zahdan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Askarihass77@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Zahedan - Fellowship
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
Askarihass77@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hasan Askari
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
askarihas77@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The main outcomes of the participants are public.
When the data will become available and for how long
6 months after the results
To whom data/document is available
Researchers at academic and academic institutions
Under which criteria data/document could be used
Statistical result
From where data/document is obtainable
Nursing and Midwifery Faculty of Zahedan
Phone and Fax: 05433442481
Zip Code: 9816913396
Address: Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
What processes are involved for a request to access data/document