The Effect of Home Care Training on Patient Caregivers on Depression and Quality of Life in Stroke Patients at Imam Khomeini Medical Center in Urmia in 2020
Determining the Effect of Home Care Training on Caregivers on Depression and Quality of Life in Stroke Patients at Imam Khomeini Medical Center in Urmia in 2020
Design
Samples will be selected by available sampling method from Imam Khomeini Medical Center of Urmia and then randomly assigned to two equal groups of intervention and control.
Settings and conduct
By referring to medical records of stroke patients, the researcher obtained the contact number and address of all patients who had had a stroke for more than four months and less than two years.In a briefing for caregivers on two consecutive days, the first day for intervention group caregivers and the second day for control group caregivers will explain the goals, stages, and duration of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Ages 18 to 75 years
- The patient's willingness to participate in the study
- Ischemic stroke based on the patient's document
patients who had had a stroke for more than four months and less than two years
- Has good cognitive ability (short Cognitive Test score greater than or equal to
Exclusion criteria:
- Being physically and mentally ill during an acute illness
- Recurrence of stroke during the study
- Patient death
Intervention groups
The intervention will include home-based care training for caregivers during four 60-minute sessions once a week by the researcher at the patients' home face-to-face, with discussion and discussion between the researcher and the patient's primary caregiver.
Main outcome variables
Depression Scores; Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046794N1
Registration date:2020-03-27, 1399/01/08
Registration timing:prospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
sevda zangbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sevdazangbari2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Home Care Training on Patient Caregivers on Depression and Quality of Life in Stroke Patients at Imam Khomeini Medical Center in Urmia in 2020
Public title
The Effect of Home Care Training on Patient Caregivers on Depression and Quality of Life in Stroke Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have had a stroke for more than four months and less than two years.
Patients who have had a stroke for more than a month and less than a year.
Patients who have no affected of orthopedic, neurologic and rheumatologic chronic disease
Exclusion criteria:
Being patient in acute conditions in terms of physical and mental
Incidence of recurrent stroke during the study
Patient death
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Using simple randomization based on random number table. Patients will be divided into two groups by random number table.
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 Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.UMSU.REC.1398.496
Health conditions studied
1
Description of health condition studied
Cerebral infarction
ICD-10 code
I63.9
ICD-10 code description
A disorder characterized by a sudden loss of sensory function due to an intracranial vascular event.
Primary outcomes
1
Description
Depression scores in Beck Questionnaire in pre and post-stroke patients between experimental and control groups
Timepoint
Before and after intervention
Method of measurement
Beck Depression Questionnaire and Stroke Specific Quality of Life Questionnaire (SSQOL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes home-based care training for caregivers during four 60-minute sessions once a week by the researcher at the home of patients face-to-face, with discussion and discussion between the researcher and the patient's primary caregiver.
Category
Lifestyle
2
Description
Control group: No training will be given to prevent depression
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Urmia
Full name of responsible person
Nader Aghakhani
Street address
Ershad Blvd
City
urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3346 9931
Email
academic.relations@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
iraj Mohebi
Street address
Orjhans Street, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
academic.relations@umsu.ac.ir
Grant name
Vice chancellor for research, Urmia University of Medical Sciences
Grant code / Reference number
11915-9999
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Orjhans Street, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
naderaghakhani2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Orjhans Street, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
naderaghakhani2000@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nader Aghakhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Orjhans Street, Resalat Blvd
City
urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
naderaghakhani2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Use data only for research purposes
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Everyone has access to published data
Under which criteria data/document could be used
Raw statistical data will not be released but statistical analysis will be available
From where data/document is obtainable
Responsible for clinical trial registration
What processes are involved for a request to access data/document
It will be possible with the permission of the Ethics Committee and the Research Deputy of Urmia University of Medical Sciences