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The effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers of patients with Alzheimer's Disease

Protocol summary

Study aim
Assessment of the effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers of patients with Alzheimer's Disease Attending Clinics Affiliated with Tabriz University of Medical Sciences
Design
This is a randomized, parallel-group, double-blind clinical trial. A total of 122 family caregivers will be enrolled and randomly assigned to either the intervention or control group using blocked randomization (block size of 6, allocation ratio 1:1). The allocation sequence will be generated by a researcher not involved in the intervention delivery (using computer software) and concealed in sequentially numbered, opaque, sealed envelopes.
Settings and conduct
Educational classroom, Imam Reza Hospital; Participants will be randomly assigned, with the intervention delivered to the intervention group; Outcome assessor and data analyst will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Primary caregivers of Alzheimer’s patients, aged 18–65 years, with at least basic literacy, minimum 6 months caregiving experience, and a first-degree familial relationship with the patient. Exclusion Criteria: The patient under care has another illness besides Alzheimer's disease, such as cancer and cardiovascular diseases.
Intervention groups
Intervention Sessions: Six in-person sessions covering program introduction, caregiver burden and mental health education, introduction to Pender’s Health Promotion Model, stress and caregiver fatigue management skills, effective communication with the patient, time management and care planning, and finally, review of topics, supplementary resources, and Question & Answer. Control participants will receive educational materials after study completion if effective.
Main outcome variables
Caregiver burden

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250902067101N1
Registration date: 2025-12-06, 1404/09/15
Registration timing: prospective

Last update: 2025-12-06, 1404/09/15
Update count: 0
Registration date
2025-12-06, 1404/09/15
Registrant information
Name
Reza Nematollahi Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 561 8507
Email address
r.nematollahi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-04-21, 1405/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers of patients with Alzheimer's Disease
Public title
The effect of a Care Program Based on Pender's Health Promotion Model on the Caregiver Burden of Family Caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18-65 Being literate Being the primary caregiver of the patient Having taken care of the patient for at least 6 months Being the first degree relative
Exclusion criteria:
The patient under care has another illness besides Alzheimer's disease, such as cancer and cardiovascular diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 120 participants meeting the inclusion criteria will be recruited for the study. A blocked randomization sequence (block size = 6, allocation ratio 1:1) will be generated using SPSS version 27 by one of the authors who is blinded to the study hypothesis and the intervention assignment. The allocation sequence will be placed in sequentially numbered, opaque, sealed envelopes and concealed until the initiation of the intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and the data analyst will be blinded to participants’ group allocation to minimize detection and analysis bias. Due to the nature of the intervention (educational program), blinding of participants and the primary investigator will not be feasible.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Approval date
2025-06-02, 1404/03/12
Ethics committee reference number
IR.TBZMED.REC.1404.252

Health conditions studied

1

Description of health condition studied
caregiver burden of patients with Alzheimer's Disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease

Primary outcomes

1

Description
Caregiver burden
Timepoint
The caregiver burden of family caregivers will be assessed at two time points: once before the intervention (baseline) and once two months after the final educational session (follow-up).
Method of measurement
Measurement will be conducted using the Caregiver Burden Inventory (CBI), administered by a trained assessor either in person or via telephone.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After completing the demographic questionnaire and the Caregiver Burden Inventory (CBI), participants in the intervention group will be divided into six subgroups of ten individuals each for group-based sessions. The caregiving program, based on Pender’s Health Promotion Model, will be delivered by one of the researchers in six 45–60-minute sessions.In the first session, following an initial assessment, the researcher, with the assistance of the patient’s caregiver, will review the goals that the caregiver needs to achieve and determine the desired outcomes for each participant. The content of the sessions will be as follows:Session 1: Introduction to the program, education on the concept of caregiver burden, and mental health.Session 2: Introduction to Pender’s Health Promotion Model and its application in caregiving.Session 3: Stress management and coping strategies for caregiver fatigue.Session 4: Training in effective communication techniques with the patient.Session 5: Time management and planning for caregiving tasks.Session 6: Review and summary of the topics, provision of supplementary resources, and addressing participants’ questions.
Category
Behavior

2

Description
Control group: Caregivers of patients with Alzheimer’s disease who meet the inclusion criteria will not receive the caregiving program based on Pender’s Health Promotion Model. If the intervention proves to be effective, the educational materials will be made available to this group in the form of a booklet.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurology Clinics of Imam Reza Hospital
Full name of responsible person
Hamed Gholizad Gougjehyaran
Street address
Azadi boulevard, Azadi dormitory
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Phone
+98 936 898 3732
Email
h.gholizad1991@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adibkia
Street address
Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Phone
+98 41 3335 7310
Email
adibkia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reza Nematollahi Maleki
Position
PhD Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi boulevard, Azadi dormitory
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Phone
+98 914 561 8507
Email
r.nematollahi@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Nematollahi Maleki
Position
PhD Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Phone
+98 914 561 8507
Email
r.nematollahi@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Nematollahi Maleki
Position
PhD Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5163958156
Phone
+98 914 561 8507
Email
r.nematollahi@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical considerations and confidentiality concerns regarding patient caregivers, there is no plan to share deidentified IPD from this study.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study Protocol – This document includes details of the study objectives, design, methodology, participant selection criteria, intervention content, and data collection tools. Only the protocol document will be shared; no individual participant data will be included.
When the data will become available and for how long
The protocol will be available upon reasonable request after publication of the main study results and will remain accessible for 3 years following publication.
To whom data/document is available
The protocol will be available to researchers and academic staff affiliated with recognized research institutions and universities.
Under which criteria data/document could be used
The protocol may be used for academic and scientific purposes only, such as designing similar studies, systematic reviews, or meta-analyses. Any use requires proper citation of the original study. Requests will be reviewed by the principal investigator.
From where data/document is obtainable
Requests should be directed to the principal investigator via email: r.nematollahi@tbzmed.ac.ir.
What processes are involved for a request to access data/document
Interested researchers should send an email request including their name, institutional affiliation, and purpose of use. Requests will be reviewed within 2–4 weeks, and approved applicants will receive the protocol in PDF format.
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