Investigating the effect of transitional care program on care burden and quality of life of family caregivers of patients with multiple chronic diseases
Determining the impact of transitional care program on care burden and quality of life of family caregivers of patients with multiple chronic diseases in selected hospitals of Isfahan University of Medical Sciences 1402
Design
A single blind randomized clinical trial with a control group, with parallel groups, on 68 caregivers using statistical software.
Settings and conduct
This study will be conducted in selected hospitals of Isfahan University of Medical Sciences. The collected data will be analyzed after coding by a researcher unaware of the control and intervention groups.
Participants/Inclusion and exclusion criteria
The person responsible for caring for the patient who needs care by family caregivers due to disability (based on the WHODAS 12-item questionnaire to determine the patient's level of disability, people with severe and very severe disability will be determined. The patient has a score of 24 to obtain the above).
Based on the self-declaration of the caregiver, the main responsibility of caring for the patient with heart failure and diabetes at the same time.
Caregiver must be over 18 years old.
The caregiver is required to be fluent in Farsi.
Participating caregivers must be willing to take part in the study.
Caregivers of family members suffering from multiple chronic diseases.
The caregiver has the primary responsibility of caring for the patient.
The caregiver should have the ability to cooperate in care, treatment, and prescribed medicines.
The caregiver does not have mental health problems.
Intervention groups
The study is in two groups. In the intervention group, family caregivers of people with diabetes and heart failure will be under care at the same time. In the control group, they receive routine services from the hospital.
Main outcome variables
Care burden and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170625034743N3
Registration date:2023-08-31, 1402/06/09
Registration timing:prospective
Last update:2023-08-31, 1402/06/09
Update count:0
Registration date
2023-08-31, 1402/06/09
Registrant information
Name
Leila Mardanian Dehkordi
Name of organization / entity
Isfahan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7541
Email address
mardanian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of transitional care program on care burden and quality of life of family caregivers of patients with multiple chronic diseases
Public title
Investigating the effect of transitional care program on care burden and quality of life of family caregivers of patients with multiple chronic diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The person responsible for caring for the patient who needs care by family caregivers due to disability (based on the WHODAS 12-item questionnaire to determine the patient's disability level, people with severe and very severe disabilities will be determined. The patient scored 24 or higher on the World Health Organization's disability assessment tool.
Based on the self-declaration of the caregiver, the main responsibility of caring for the patient with heart failure and diabetes at the same time.
The caregiver must be over 18 years old.
Caregiver must speak Farsi.
Caregivers are willing to participate in the study.
Caregivers of family members suffering from multiple chronic diseases.
The caregiver has the primary responsibility of caring for the patient.
The caregiver should have the ability to cooperate in care, treatment, and prescribed medicines.
The caregiver does not have mental health problems.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
First, people will be selected by the available sampling method and will be placed in the intervention (A) and control (B) groups based on four blocks. First, blocks of four will be prepared as follows: AABB, ABAB, ABBA, BBAA, BABA, BAAB, then these blocks will be arranged randomly and people will be allocated according to A and B in two intervention and control groups; These will be repeated continuously until the sample size is completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher conducting data analysis will be blinded to the control and intervention groups, analyzing coded data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hazarjarib St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.MUI.NURSEMA.REC.1402.091
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
2
Description of health condition studied
heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Burden of Care
Timepoint
before the intervention and two months after the intervention
Method of measurement
Zarit Care Burden Questionnaire
2
Description
Quality of Life
Timepoint
before the intervention and two months after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire 26 questions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before starting the study, the participants complete demographic questionnaires, burden of care, and quality of life, and then they are under the care of a caregiver, Two months after discharge, the questionnaires are completed again by the caregiver.
Category
Treatment - Other
2
Description
Control group: Demographic, burden of care, and quality of life questionnaires are completed before the start of the study and the participants receive the usual care and counseling provided by the hospital. Then, after two months after the discharge, the questionnaires are filled again by the caregiver. The contents of the program will be available to the control group after the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Heart Training and Research Center
Full name of responsible person
Leila Mardanian Dehkordi
Street address
Shahid Chamran Heart Training and Research, after Shahristan Bridge,CenterThird Mushtaq St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3260 0961
Email
hfrc@mui.ac.ir
2
Recruitment center
Name of recruitment center
Khurshid educational, therapeutic and research complex
Full name of responsible person
Leila Mardanian Dehkordi
Street address
Khurshid Educational Therapy and Research Complex, Ostandari St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Deputy of Research and Technology, Building No.4, Isfahan University of Medical Sciences and Health Services, HazarJarib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Karami
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mrymkrmi099@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Mardanian Dehkordi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
leila.mardanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Mardanian Dehkordi
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib Street, Isfahan Univesity of Medical Sciences, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7541
Fax
+98 31 3669 9398
Email
mardanian@nm.mui.ac.ir
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 collected data will be published through a paper.
When the data will become available and for how long
One year after study
To whom data/document is available
Reviewers and authors of the article
Under which criteria data/document could be used
Data are available from the authors upon reasonable request and with permission.
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
By correspondence with the corresponding author via email