The effect of the self-management program based on 5A Model on caregiver burden and Apgar score of family caregivers of patients with stroke.
Design
The present clinical trial was performed with a control group in which 64 caregivers of patients was enrolled
Settings and conduct
The present study was performed at Shahid Beheshti Hospital in Kashan. No blinding was carried out in this study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All families of stroke patients who had a stroke a week before, and had a medical record at the hospital indicating a definitive diagnosis of stroke.
Non-inclusion criteria: Participation of families in similar studies.
Intervention groups
The intervention group (n= 32) was divided into two groups of 16. Eight one-hour theoretical and practical training sessions were held for each group over five weeks in a classroom in the neurology department of Shahid Beheshti Hospital in the city of Kashan. Control group: received only routine hospital care. At the end of the study, the educational booklet was given to the control group to observe ethical considerations.
Main outcome variables
Burden of care, total Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042096N1
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Maryam Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5520 5997
Email address
maryamheydari779@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-24, 1398/04/03
Expected recruitment end date
2019-08-03, 1398/05/12
Actual recruitment start date
2019-06-24, 1398/04/03
Actual recruitment end date
2019-08-03, 1398/05/12
Trial completion date
2019-08-03, 1398/05/12
Scientific title
The effect of self-management program based on the Five A model on care burden and APGAR score of family caregivers of stroke patients
Public title
The effect of self-management program on care burden and APGAR score of family caregivers of stroke Patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent for taking part in the study
Reading and writing literacy
All families of stroke patients who had a stroke one week before, and had a medical record at the hospital indicating definitive diagnosis of stroke
Exclusion criteria:
Participation of families in similar studies.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
64
Actual sample size reached:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization was performed by using a table of random numbers. The numbers in the table were used from the top to the bottom. Even numbers were considered for the experimental group and odd numbers for the control group. Opaque and sealed envelopes and random sequences were used for blinding. Each generated random sequence was written on a card; the cards were placed inside the envelopes; and the envelopes were sealed and placed in a box. At the time of participant registration, based on the order of the inclusion of eligible participants, one envelope was opened and the group to which that participant was allocated was revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
At the outset of the study, explanations about the method were given to the caregivers, but no explanation was provided about group allocation. At the end of the study, an educational pamphlet was given to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation; Kkodakyar Ave.; Daneshjo blvd.; Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2019-05-29, 1398/03/08
Ethics committee reference number
IR.USWR.REC.1398.013
Health conditions studied
1
Description of health condition studied
patients with stroke
ICD-10 code
164
ICD-10 code description
Stroke,not specified as hemorrhage or infarction
Primary outcomes
1
Description
Burden of care
Timepoint
At the beginning of the study and six weeks after the intervention
Method of measurement
Zarit Burden Interview
2
Description
Total family Apgar score
Timepoint
At the beginning of the study and six weeks after the intervention
Method of measurement
Smilkstein Family Apgar Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group comprised 32 people, divided into two groups of 16. For each group, the theoretical and practical class was provided in eight one-hour sessions for five weeks. The classes were held in the Neurology Ward of Shahid Beheshti Hospital, Kashan, Iran. The self-management program implemented in this study consisted of group theoretical and practical training as well as follow-up performed online and over the phone, provided for the family caregivers of patients with stroke.
Category
Other
2
Description
Control group:The control group received only routine hospital care. At the end of the study, the educational booklet was given to the control group to observe ethical considerations.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Maryam Heydari
Street address
Misaq 4 Opposite Barghi School End of Resalat Ave. Kashan
City
Kashan
Province
Isfehan
Postal code
8716896641
Phone
+98 31 5520 5997
Email
maryamheydari779@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Mohammadreza Khodaeiardakani
Street address
Kodakyar closed alley, Daneshjo Blvd., Evin.
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0036
Email
maryamheydari779@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Heydari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Misaq 4; in front of Barghi School; at the end of Resalat avenue
City
Kashan
Province
Isfehan
Postal code
8716896641
Phone
+98 31 5520 5997
Email
maryamheydari779@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Heydari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Misaq 4; in front of Barghi School; at the end of Resalat avenue
City
Kashan
Province
Isfehan
Postal code
8716896641
Phone
+98 31 5520 5997
Email
maryamheydari779@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Heydari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Misaq 4 Opposite Barghi School End of Resalat Ave. Kashan
City
Kashan
Province
Isfehan
Postal code
8716896641
Phone
+98 31 5520 5997
Email
maryamheydari779@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available