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Evaluating the Effectiveness of a Problem-Solving Skills Educational Intervention on Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients Referred to Healthcare Centers

Protocol summary

Study aim
Determining the Effectiveness of a Problem-Solving Skills Training Intervention on Resilience and Caregiver Burden Among Family Caregivers of Older Adults Undergoing Hemodialysis
Design
A two-group, randomized, non-blinded quasi-experimental study with a pretest–posttest design and follow-up was conducted on 68 caregivers. Random allocation was performed using the RAND function in Microsoft Excel.
Settings and conduct
This study will be conducted at a hemodialysis center in Shiraz. After obtaining the required approval and coordinating with the head nurse, eligible caregivers will be identified through review of patients’ medical records and interviews. Those who meet the inclusion criteria will be enrolled in the study after providing informed consent. The study will be conducted in a non-blinded manner.
Participants/Inclusion and exclusion criteria
Inclusion criteria for caregivers: Being the primary caregiver who provides at least 4 hours of care per day; having no diagnosed psychiatric disorders; and being able to read and write. Inclusion criteria for older adults: Age 65 years or older; absence of severe cognitive impairment; having no more than two diagnosed chronic diseases; and having a primary family caregiver. Exclusion criteria: Patient’s death; caregiver absence from two educational sessions; diagnosis of a new illness in the patient; unwillingness to continue participation; or occurrence of a family crisis during the study period.
Intervention groups
Thirty-four caregivers in the intervention group will be divided into five small subgroups of 5–8 participants and will attend five weekly educational sessions (approximately one hour each). The sessions will be conducted by the nurse researcher and will include a combination of brief lectures, PowerPoint presentations, group discussions, and question-and-answer segments.
Main outcome variables
Caregiver Burden , Resilience

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260215068868N1
Registration date: 2026-02-16, 1404/11/27
Registration timing: prospective

Last update: 2026-02-16, 1404/11/27
Update count: 0
Registration date
2026-02-16, 1404/11/27
Registrant information
Name
shaghayegh yadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3643 6892
Email address
shaghayeghyadollahi547@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-20, 1404/12/01
Expected recruitment end date
2026-03-06, 1404/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effectiveness of a Problem-Solving Skills Educational Intervention on Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients Referred to Healthcare Centers
Public title
Evaluating the Effectiveness of a Problem-Solving Skills Educational Intervention on Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients Referred to Healthcare Centers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for caregivers: having no diagnosed psychiatric disorders Willingness to participate in the study. Ability to read and write. Age between 18 and 65 years No participation in similar educational programs during the past six months Inclusion criteria for older adults: Age 65 years or older No severe cognitive impairment or dementia Having no more than two diagnosed chronic diseases. No history of kidney transplantation Having a primary family caregiver for home care
Exclusion criteria:
Patient death Caregiver absence from two educational sessions Diagnosis of a new illness in the patient Caregiver’s unwillingness to continue participation during the study Occurrence of a family crisis (such as divorce, financial crisis, or death of a first-degree family member) during the study period
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are allocated to either the intervention or control group through simple randomization using the last two digits of their national ID numbers. Specifically, if the last two digits of the national ID number are even, the individual is assigned to the intervention group, and if they are odd, they are assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Jiroft University of Medical Sciences
Street address
Research and Technology Vice-Chancellery Building, Pasdaran Blvd, Jiroft, Iran
City
Jiroft
Province
Kerman
Postal code
7861634200
Approval date
2025-09-23, 1404/07/01
Ethics committee reference number
IR.JMU.REC.1404.032

Health conditions studied

1

Description of health condition studied
Caregiver Burden and Resilience among Family Caregivers of Elderly Hemodialysis Patients
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure

Primary outcomes

1

Description
Resilience
Timepoint
Data will be analyzed using descriptive statistics, independent t-test, paired t-test, and, if necessary, non-parametric tests
Method of measurement
The Connor- Davidson Resilience Scale, and the Zarit Burden Interview

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group:In this group, 34 caregivers will be allocated through simple randomization (based on whether the last two digits of their national ID number are even or odd). Participants will attend five weekly problem-solving skills training sessions over five consecutive weeks (each session lasting approximately one hour). The sessions will be conducted by the nurse researcher and will include a combination of brief lectures with PowerPoint presentations, group discussions, and question-and-answer segments. At the end of the first session, an educational booklet will be provided to participants. Questionnaires will be completed at three time points: before the intervention, immediately after completion of the sessions, and one month after the end of the intervention.
Category
Other

2

Description
Control group: Another 34 caregivers who are randomly assigned to the control group will receive no training or intervention during the study period and will only complete the questionnaires at the same three time points as the intervention group. To adhere to research ethics principles, after the completion of the study, the educational content will be delivered to this group in a two-hour session, and the educational booklet will also be provided to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Educational and Medical Center, Shiraz
Full name of responsible person
Dr Mohammad Rahmanian
Street address
Namazi Educational and Medical Center, Namazi Square, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71936133311
Phone
+98 71 3612 5000
Email
Nemazee_inf@sums.ac.ir

2

Recruitment center
Name of recruitment center
Abu Ali Sina Organ Transplantation Hospital, Shiraz, Iranی
Full name of responsible person
Dr Bagher Khosravi
Street address
Sadra New City, Phase 2, toward Dokouhak, opposite Pardis Garden City, Shiraz
City
Shiraz
Province
Fars
Postal code
7199467985
Phone
+98 71 3640 7064
Email
abualisinacharity@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Dr.ali asghar kheir khah
Street address
Central Headquarters of Jiroft University of Medical Sciences and Health Services, Shohadaye Ashayer Building, Enghelab Square, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 9085
Email
suport@jmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
Shaghayegh Yadollahi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Unit 23, Block A, Pasargad Building, Molana 5 Street, Molana Boulevard, Sadra, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7199885943
Phone
009871336436892
Email
shaghayeghyadollahi547@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Dr Motahare Faramarzpoor
Position
consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jiroft University of Medical Sciences, Shahed Square, Bargh Township, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 9085
Email
mfaramarzpor61@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
shaghaygh yadollahi
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Unit 23, Block A, Pasargad Building, Molana 5 Street, Molana Boulevard, Sadra, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7199885943
Phone
+98 71 3643 6892
Email
shaghayeghyadollahi547@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Based on the findings of the study, educational content tailored to the needs of family caregivers of older adults undergoing hemodialysis will be developed. This content will be designed in the form of simple, easy-to-understand educational brochures using non-technical language and practical instructional images. In addition, a short educational video focusing on problem-solving skills training and strategies to enhance caregivers’ resilience will be produced. This video can be presented in dialysis centers, health education programs, and health-related social media platforms. In developing these materials, the scientific findings of the study and the real needs of caregivers will be utilized to ensure that the content is practical, effective, and understandable for the general public.
When the data will become available and for how long
After completion of the study
To whom data/document is available
Submission of the research findings to Shiraz University of Medical Sciences Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers Publication of the article in reputable national or international scientific journals Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease
Under which criteria data/document could be used
Follow-up and evaluation of learning through questionnaires and home-based exercises Designing simple and practical tools (such as brochures and problem-solving checklists) for caregivers to use in the home setting
From where data/document is obtainable
Submission of the research findings to Shiraz University of Medical Sciences Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers Publication of the article in reputable national or international scientific journals Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease
What processes are involved for a request to access data/document
Submission of the research findings to Shiraz University of Medical Sciences Presentation of the findings at meetings of Clinical Ethics Committees and Quality Improvement Committees in healthcare centers Publication of the article in reputable national or international scientific journals Sharing the findings with associations related to older adults, caregivers, and patients with kidney disease
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