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IRCT20260611069749N1 IRCT 2026-07-09 Tarbiat Modares University Effect of a Hypertension Self-Care Program on Self-Care and Quality of Life among Hospital Employees with High Blood Pressure 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 2026-09-01 anticipated 120 Recruiting https://irct.ir/trial/91290 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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, 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. N/A Essential (primary) hypertension. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Lubna Al-Sbehat
Department of Nursing, Faculty of Medical Sciences, Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 14115-111 +98 939 794 9175 lubna.alsbehat@modares.ac.ir Tarbiat Modares University scientific Fatemeh Alhani
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3590 alhani_f@modares.ac.ir Tarbiat Modares University Iraq Iraq 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. 30 years 65 years Both 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. I10 Essential (primary) hypertension Behavior N/A 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. 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. 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. 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. 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. Tarbiat Modares University Approved 2026-02-07 Ethics Committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of) Approved 2026-04-22 Research Ethics Committee of the Iraqi Ministry of Health Iraqi Ministry of Health, National Centre for Training and Human Development, Baghdad, Iraq Baghdad Baghdad Iraq