Determining the impact of a supportive educational intervention on medication management and the perceived stress level of family caregivers of the elderly
Design
A controlled trial with parallel groups, non-blinded, non-randomized, conducted on 52 family caregivers of the elderly
Settings and conduct
The research will be conducted in Gonabad and Ferdows counties. In the intervention group, the researcher will visit the elderly person's home for three in-person sessions to review the medication bag and provide medication management education. Then, 2 to 3 follow-up phone calls will be made to address any issues or concerns the caregivers have regarding medication management. No intervention will be done in the control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
The main caregiver must be a family member of an elderly person with chronic diseases.
The family caregiver must be the primary person responsible for caring for an elderly person with multiple chronic diseases.
Exclusion Criteria:
Death of the elderly person.
Caregiver's unwillingness to continue participating in the study.
Intervention groups
In the intervention group, the researcher will visit the elderly person's home for three in-person sessions to: Review the elderly person's medication bag, Provide general information about the purpose and side effects of each medication,Teach how to prepare medications, Educate on the correct dosage, timing, and method of medication administration. After completing the in-person sessions, the researcher will follow up by phone 2 to 3 times to address any issues or concerns the caregivers may have regarding the topics mentioned. No specific intervention will be conducted in the control group.
Main outcome variables
Medication management level of family caregivers; perceived stress level of family caregivers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241102063567N1
Registration date:2024-11-12, 1403/08/22
Registration timing:prospective
Last update:2024-11-12, 1403/08/22
Update count:0
Registration date
2024-11-12, 1403/08/22
Registrant information
Name
Mahmood Baniasad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3273 1314
Email address
mahmood.baniasad@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-02-03, 1403/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive educational intervention on medication management and perceived stress of elderly family caregivers
Public title
The effect of supportive educational intervention on medication management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be the primary caregiver for an elderly family member with chronic illnesses
Be at least 18 years old
The family caregiver must be primarily responsible for caring for an elderly person with multiple chronic illnesses (providing the majority of daily care hours and recognized by the patient as the main caregiver)
Have primary responsibility for managing the elderly person's medications
Have provided care for more than six months
The caregiver should not have any mental illness and should not be using psychiatric medications
No major stressful events for the caregiver in the past 6 months
Be willing to participate in the study
Exclusion criteria:
Occurrence of a stressful event for the caregiver during the study
Death of the elderly person
Caregiver's unwillingness to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be classified into two age groups of family caregivers: under 50 years and over 50 years. Then, randomization will be done within each class, so that the samples from each of the two age classes will be assigned equally and using simple random sampling to the intervention and control groups, based on a random numbers 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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, on the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
info@gmu.ac.ir
Approval date
2024-10-15, 1403/07/24
Ethics committee reference number
IR.GMU.REC.1403.060
Health conditions studied
1
Description of health condition studied
Medication management of family caregivers, perceived stress of family caregivers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Medication management
Timepoint
Before and after the intervention
Method of measurement
Medication Managment Instrument for Deficiencies in the Elderly
2
Description
Perceived stress
Timepoint
Before and after the intervention
Method of measurement
The Cohen Perceived Stress Scale (1983)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Review of the elderly person's medication bag (prescription medications, over-the-counter medications, supplements, herbal medicines), identification of duplicate medications, providing general information on the use of each medication, educating on the side effects of the elderly person's medications and necessary interventions in case of side effects, ensuring adherence to prescribed dosages, teaching how to prepare medications, teaching the correct timing for medication administration, educating on the proper way to use medications (e.g., how each medication should be administered, such as sublingually, swallowed, chewed, sprayed, etc., and the correct technique for using each type, such as how to administer eye and nasal drops, how to spray, and other specific considerations for each method), providing information on medication storage and specific instructions for each medication (e.g., how much liquid to use with each medication, whether it should be taken with food or on an empty stomach, after using an antacid, etc.), and educating on sources for obtaining each medication.
Category
Other
2
Description
Control group: There will be no special intervention in this group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdows Health Center
Full name of responsible person
Mohammad Reza Hosseinizadeh
Street address
Health and Medical Department, Khorramshahr Street
City
Ferdows
Province
South Khorasan
Postal code
9771648719
Phone
+98 56 3272 2976
Fax
+98 56 3272 2839
Email
Ferdows@bums.ac.ir
2
Recruitment center
Name of recruitment center
Gonabad Health Center
Full name of responsible person
Dr. Javad Sadeghi Nasab
Street address
Gonabad University of Medical Sciences, on the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
behdasht.gmu.ac.ir
Phone
+98 51 5722 9012
Fax
+98 51 5722 0193
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Firouzi Chahak
Street address
Gonabad University of Medical Sciences, on the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
research@gmu.ac.ir
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
research@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Birjand University of Medical Sciences
Full name of responsible person
Mahmood Baniasad
Position
clinical supervisor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Behyar street., Salamat Blvd., Behdari Town
City
Ferdows
Province
South Khorasan
Postal code
9771946366
Phone
+98 56 3273 1314
Email
mahmood.baniasad@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Leila Sadegh Moghadam Abbaspour
Position
Specialized doctorate in gerontology
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Gonabad University of Medical Sciences, on the side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
ls_moghadam@yahoo.co
Phone
+98 51 5722 3028
Email
ls_moghadam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahmood Baniasad
Position
clinical supervisor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Behyar street., Salamat Blvd., Behdari Town
City
Ferdows
Province
South Khorasan
Postal code
9771946366
Phone
+98 56 3273 1314
Email
mahmood.bniasad@bums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data obtained regarding the target population of this study pertains to demographic information and the two main outcomes of the study, namely medication management and perceived stress. These data will be reported anonymously and presented as results from the analysis of the obtained findings.
When the data will become available and for how long
The access period will begin 6 months after the publication of the results.
To whom data/document is available
Researchers in the fields of nursing and aging, all healthcare providers, health policymakers, nursing professionals, and aging specialists.
Under which criteria data/document could be used
Citing the researchers of this study
From where data/document is obtainable
To receive the documents, send a request to the following email address:
mahmood.baniasad@bums.ac.ir
What processes are involved for a request to access data/document
To request documentation, please send an email to the address below. A response will be provided as soon as possible after the review is completed.
mahmood.baniasad@bums.ac.ir