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Effectiveness of an Evidence-Based Hypertension Self-Care Intervention Developed Using Intervention Mapping versus Usual Care on Self-Care, Self-Efficacy, and Quality of Life among Hospital Employees with Hypertension: A Randomized Controlled Trial

Protocol summary

Study aim
To evaluate the effect of an evidence-based Hypertension Self-Care Intervention Map on self-care behaviour, self-efficacy, and quality of life among hospital employees with essential hypertension in Baghdad.
Design
Two-arm, parallel-group, open-label randomized controlled trial with 120 participants, 60 per group. Individual block randomization will be stratified by hospital in a 1:1 ratio, with both groups represented at both centers.
Settings and conduct
The trial will be conducted in two Baghdad hospitals. After consent and baseline assessment, participants will be randomized within each hospital. Trained nurses will deliver the intervention separately from controls. Outcomes will be reassessed after 45 days. The study is open-label, with coded data.
Participants/Inclusion and exclusion criteria
Full-time hospital employees aged 30–65 years with physician-diagnosed essential hypertension for at least six months, receiving treatment, able to communicate in Arabic, and providing written consent. Physicians, nurses, those unable to complete study procedures, those planning to leave the hospital, and those withdrawing consent will be excluded.
Intervention groups
The intervention group will receive the Hypertension Self-Care Intervention Map plus usual care through approximately six nurse-led sessions over 45 days, practical activities, and follow-up messages. The control group will receive usual care only and may receive educational materials after post-test data collection.
Main outcome variables
Self-care behaviour and self-efficacy measured with the Arabic Hypertension Self-Care Profile, and quality of life measured with the Arabic World Health Organization Quality of Life-Brief Version, at baseline and post-test.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260611069749N1
Registration date: 2026-07-09, 1405/04/18
Registration timing: prospective

Last update: 2026-07-09, 1405/04/18
Update count: 0
Registration date
2026-07-09, 1405/04/18
Registrant information
Name
Lubna Al-sbehat
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 939 794 9175
Email address
lubna.alsbehat@modares.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-01, 1405/06/10
Expected recruitment end date
2026-11-30, 1405/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of an Evidence-Based Hypertension Self-Care Intervention Developed Using Intervention Mapping versus Usual Care on Self-Care, Self-Efficacy, and Quality of Life among Hospital Employees with Hypertension: A Randomized Controlled Trial
Public title
Effect of a Hypertension Self-Care Program on Self-Care and Quality of Life among Hospital Employees with High Blood Pressure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Hospital employee aged 30 to 65 years. Physician-confirmed diagnosis of essential hypertension for at least six months. Full-time employment in one of the selected study hospitals. Receiving hypertension management through medication, lifestyle recommendations, or both. Ability to communicate in Arabic. Voluntary willingness to participate and ability to provide written informed consent.
Exclusion criteria:
Employment as a physician or nurse. Severe acute physical illness that prevents participation in the study. Severe mental illness or cognitive impairment that prevents questionnaire completion or participation in the intervention. Baseline inability to complete the questionnaires or study procedures. Planned resignation, retirement, transfer from the selected hospital, or prolonged absence during the study period.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
After confirmation of eligibility, obtaining written informed consent, and completion of the baseline assessment, participants within each hospital will be randomly allocated to the intervention or control group using hospital-stratified block randomization with a 1:1 allocation ratio. The unit of randomization will be the individual participant, not the hospital or work unit. A separate randomization sequence will be generated for each hospital using a reproducible computerized random-number procedure. Participant identification codes rather than names will be used in the allocation list. The randomization list will be kept separate from recruitment and baseline data-collection records. Group assignment will be revealed only after the participant has completed the baseline assessment, thereby maintaining allocation concealment until assignment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This trial constitutes the fourth and final evaluation stage of a multiphase mixed-methods study. The Hypertension Self-Care Intervention Map will be developed through the integration of quantitative and qualitative findings using the Intervention Mapping framework. During the trial stage, participants will be randomized individually within each hospital using hospital-stratified block randomization; therefore, both intervention and control participants will be represented at each hospital. The hospitals will serve as study sites and stratification factors rather than units of randomization. Outcomes will be assessed at baseline and after completion of the intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2026-02-07, 1404/11/18
Ethics committee reference number
IR.MODARES.REC.1404.242

2

Ethics committee
Name of ethics committee
Research Ethics Committee of the Iraqi Ministry of Health
Street address
Iraqi Ministry of Health, National Centre for Training and Human Development, Baghdad, Iraq
City
Baghdad
Postal code
10047
Approval date
2026-04-22, 1405/02/02
Ethics committee reference number
Decision No. 52/2026

Health conditions studied

1

Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Hypertension self-care behaviour score
Timepoint
At baseline before randomization and after completion of the 45-day intervention period.
Method of measurement
Measured using the Arabic-adapted 19-item Hypertension Self-Care Profile Self-Care Behaviour Scale. Each item is scored from 1 (rarely or never) to 4 (always), giving a total score ranging from 19 to 76. Higher scores indicate more frequent hypertension self-care behaviours.

2

Description
Hypertension self-care self-efficacy score
Timepoint
At baseline before randomization and after completion of the 45-day intervention period.
Method of measurement
Measured using the Arabic-adapted 19-item Hypertension Self-Care Profile Self-Efficacy Scale. Each item is scored from 1 (not confident) to 4 (very confident), giving a total score ranging from 19 to 76. Higher scores indicate stronger self-efficacy for performing hypertension self-care behaviours.

Secondary outcomes

1

Description
Quality-of-life domain scores
Timepoint
At baseline before randomization and after completion of the 45-day intervention period.
Method of measurement
Measured using the validated Arabic version of the World Health Organization Quality of Life–Brief Version questionnaire. The questionnaire contains 26 items: two general items and 24 items distributed across four domains: physical health, psychological health, social relationships, and environment. Items are scored on a five-point scale. Items 3, 4, and 26 are reverse-scored. Domain scores are calculated and transformed according to the instrument scoring manual, with higher scores indicating better quality of life.

Intervention groups

1

Description
Intervention group: Participants will receive the Hypertension Self-Care Intervention Map in addition to usual care. The program will include approximately six group sessions, each lasting 45–60 minutes, delivered over a 45-day period by trained nurse educators and/or trained facilitators. The sessions will address hypertension knowledge, medication adherence, healthy diet and salt reduction, physical activity, blood pressure monitoring, stress management, self-efficacy, goal setting, and problem solving. Interactive methods will include group discussion, demonstration, role play, peer support, practical exercises, and guided goal setting.
Category
Behavior

2

Description
Control group: Participants allocated to the control group will continue to receive usual care during the study period and will not receive the structured Hypertension Self-Care Intervention Map sessions during the intervention period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghazi Al-Hariri Hospital for Surgical Specialties
Full name of responsible person
Lubna Al-Sbehat
Street address
Bab Al-Muadham, Baghdad, Iraq
City
Baghdad
Postal code
10047
Phone
+964 790 192 5644
Email
medicalcity2004@yahoo.com

2

Recruitment center
Name of recruitment center
Ibn Al-Bitar Hospital for Cardiac Surgery
Full name of responsible person
Lubna Al-Sbehat
Street address
Al-Salihiya, opposite the Iraqi Museum, Baghdad, Iraq
City
Baghdad
Postal code
10002
Phone
+964 781 797 2046
Email
ibn-bitarcardiac-surgery@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Fatemeh Alhani
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3590
Email
alhani_f@modares.ac.ir
Web page address
https://en-med.modares.ac.ir
Grant name
No external grant
Grant code / Reference number
Not applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Lubna Al-Sbehat
Position
PhD Student in Nursing
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 939 794 9175
Email
lubna.alsbehat@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Alhani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3590
Email
alhani_f@modares.ac.ir
Web page address
https://en-med.modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Lubna Al-Sbehat
Position
PhD Candidate in Nursing
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 939 794 9175
Email
lubna.alsbehat@modares.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
Deidentified individual participant data will not be shared because the study involves sensitive health-related data from patients with hypertension recruited from specific hospital settings. Even after deidentification, there may be a risk of indirect identification. Data sharing is also limited by the informed consent conditions, ethical approvals, and institutional regulations. Only aggregated results will be reported in publications and academic outputs.
Study Protocol
No - There is not 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
Not applicable
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
The statistical analysis plan and the blank informed consent form will be shared. These documents will not include identifiable participant information or individual participant-level data.
When the data will become available and for how long
The documents will become available after publication of the main study results or completion of the doctoral dissertation, whichever occurs first, and will remain available for five years.
To whom data/document is available
The documents will be available to qualified researchers affiliated with academic or research institutions upon reasonable request.
Under which criteria data/document could be used
Requests must include a clear academic or scientific purpose and must comply with ethical approvals, participant confidentiality, and institutional regulations. The documents may be used for scientific research, methodological reference, or research planning only.
From where data/document is obtainable
Requests should be submitted by email to the principal investigator at lubna.alsbehat@modares.ac.ir. Requests may be reviewed in consultation with the study supervisor and Tarbiat Modares University.
What processes are involved for a request to access data/document
The applicant should submit a written request specifying the requested document, scientific purpose, institutional affiliation, and planned use. The research team will review the request and, if approved, provide the documents electronically.
Comments
No deidentified individual participant data will be shared.
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