Determining the effectiveness of family-centered education on the care burden and anxiety of caregivers of the elderly with type 2 diabetes
Design
Clinical trial on diabetic and caring elderly،has an intervention and control group، simple randomization of even and odd with a sample size of 46 people in each group
Settings and conduct
The study site was at diabetic clinic of Khatam Al Anbia Hospital, Behshahr. Participants were selected by simple random method, and divided into two groups, intervention group and control group. The pre-test questionnaire was given to both groups and completed. Intervention group got four sessions of 45-minutes training based on an educational booklet, but the control group received routine care. Finally, both groups were given a post-test after one month that the intervention group's education was done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Able to read and understand Persian language
questionnaire.
2-The caregiver has not previously attended relevant training sessions
Exclusion criteria:
1-patient or family member cannot participate in all educational sessions
2-Caregivers and patients do not want to continue working together
Intervention groups
Explanation about diabetes,personal care training,drug management,diet management، daily life activities and ways to reduce the burden of care caregivers and caring for a diabetic elderly
Main outcome variables
Care burden; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047750N1
Registration date:2020-08-29, 1399/06/08
Registration timing:retrospective
Last update:2020-08-29, 1399/06/08
Update count:0
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
Mosa Kohsari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3215 7139
Email address
mosaa.kohsari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered education on family burden and anxiety of caregivers of elderly with type 2 diabetes
Public title
Effectiveness of family-centered education in diabetes type 2
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Caregiver must be the next of kin of the patient and take full care of the patient (at least four days of a week).
Have the ability to read and comprehension of Farsi
Caregiver must not take care of any other patient than the diabetic patient
The patient does not have a stroke, severe heart problems or be a dialysis patient.
The caregiver must not suffer from mental, neurological or physical disorders
The caregiver must not be a member of medical staff.
Exclusion criteria:
Patient or family member cannot participate in all educational sessions
Caregivers and patients do not want to continue working together
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Random distribution to intervention and control groups:
In this study, 46 number 1 and number 2 were placed in envelopes. During sampling, each participant got an envelope randomly. Then, number 1 were recognized as intervention group and participants with number 2 were named the control group
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
Babol University of Medical Sciences
Street address
Gorgan, Janbazan St., 560 Army Hospital
City
Behshahr
Province
Mazandaran
Postal code
4916795478
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.317
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.6
ICD-10 code description
Type 2 diabetes mellitus with other specified complications
Primary outcomes
1
Description
Care burden
Timepoint
Before starting the intervention and One month after the end of the intervention
Method of measurement
Caregiver burden inventory
2
Description
Anxiety
Timepoint
Before starting the intervention and One month after the end of the intervention
Method of measurement
Spielberger Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family caregivers for type 2 diabetics who have been trained for 4 Meeting-45-minute sessions based on a textbook.Training includes activities in the field of personal care,drug management,diet management,daily life activities and ways to reduce the burden of caregivers
Category
Behavior
2
Description
Control group: Family caregivers for type 2 diabetics who have received routine training
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Musa Koohsari
Street address
Janbazan Street, 560 Army Hospital
City
Gorgan
Province
Golestan
Postal code
4916795478
Phone
+98 17 3222 9595
Email
mosaa.kohsari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganj Afrooz Street, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Musa Koohsari
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Janbazan Street, 560 Army Hospital
City
Gorgan
Province
Golestan
Postal code
4916795478
Phone
+98 17 3222 9595
Email
mosaa.kohsari@gmail.com
Web page address
https://www.mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Musa Koohsari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Janbazan Street, 560 Army Hospital
City
Gorgan
Province
Golestan
Postal code
4916795478
Phone
+98 17 3222 9595
Email
mosaa.kohsari@gmail.com
Web page address
https://www.mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fariba Hatami
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Janbazan Street, 560 Army Hospital
City
Gorgan
Province
Golestan
Postal code
4916795478
Phone
+98 17 3222 9595
Email
hatamifariba577@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
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