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IRCT20260804070529N1 IRCT 2026-08-19 Islamic Azad University, Isfahan Branch (Khorasgan) The Effect of Applying the Transtheoretical Model of Behavior Change on Self-Care Status of Adults with Chronic Obstructive Pulmonary Disease (COPD) The Effect of Applying the Transtheoretical Model of Behavior Change on Self-Care Status of Adults with Chronic Obstructive Pulmonary Disease (COPD) 2026-09-11 anticipated 40 Complete https://irct.ir/trial/92253 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible adults with chronic obstructive pulmonary disease (COPD) will be recruited through convenience sampling after meeting the inclusion criteria and providing written informed consent. Participants will then be randomly allocated to the intervention or control group in a 1:1 ratio using a random number table (simple randomization). N/A Chronic Obstructive Pulmonary Disease; COPD. Intervention 1: Intervention group: Participants will receive a transtheoretical model (TTM)-based educational intervention according to their stage of behavior change (precontemplation, contemplation, preparation, action, and maintenance). The intervention will be delivered through face-to-face training sessions lasting 45–60 minutes. Outcomes will be assessed at baseline, immediately after the intervention, and one month after completion of the intervention. Intervention 2: Control group: Participants will receive routine care without the TTM-based educational intervention during the study period. They will complete the same assessments at baseline, immediately after the intervention period, and one month later. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Dr. Shayesteh Salehi
Jey Sharqi Street, Arghavanieh, Daneshgah Boulevard, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan.
Isfahan Iran (Islamic Republic of) 39998-81551 +98 913 209 2997 salehi@nm.mui.ac.ir Islamic Azad University, Isfahan Branch (Khorasgan) scientific Dr. Shayesteh Salehi
Jey Sharqi Street, Arghavanieh, Daneshgah Boulevard, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan.
Isfahan Iran (Islamic Republic of) 39998-81551 +98 913 209 2997 salehi@nm.mui.ac.ir Islamic Azad University, Isfahan Branch (Khorasgan) Iran (Islamic Republic of) Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on physician diagnosis or post-bronchodilator spirometry (FEV₁/FVC < 0.70). Willingness to participate and provision of written informed consent. Being in the precontemplation, contemplation, or preparation stage of behavior change. No history of asthma, pneumonia, active malignancy, or immunodeficiency. 18 years no limit Both Development of dementia or an uncontrolled psychiatric disorder during the study. Development of unstable heart disease, heart failure, bronchiectasis, bronchial carcinoma, or interstitial lung disease during the study. Withdrawal of informed consent or voluntary withdrawal from the study at any time. J44.9 Chronic obstructive pulmonary disease, unspecified Behavior Behavior Intervention group: Participants will receive a transtheoretical model (TTM)-based educational intervention according to their stage of behavior change (precontemplation, contemplation, preparation, action, and maintenance). The intervention will be delivered through face-to-face training sessions lasting 45–60 minutes. Outcomes will be assessed at baseline, immediately after the intervention, and one month after completion of the intervention. Control group: Participants will receive routine care without the TTM-based educational intervention during the study period. They will complete the same assessments at baseline, immediately after the intervention period, and one month later. Self-care status. Timepoint: Self-care will be measured at baseline (pre-intervention), immediately after the intervention (post-intervention), and 1 month after the intervention (follow-up). Method of measurement: Self-care will be assessed using the Miller Self-Care Questionnaire. This 20-item instrument evaluates self-care behaviors, including adherence to prescribed diet, smoking avoidance, physical activity, medication adherence, and stress management. Items are rated on a 5-point Likert scale, with higher scores indicating better self-care status. Stage of behavior change. Timepoint: Stage of behavior change will be measured at baseline, immediately after the intervention, and 1 month after the intervention. Method of measurement: The stage of behavior change will be assessed using the University of Rhode Island Change Assessment (URICA) Questionnaire, which evaluates participants’ readiness for behavior change based on the transtheoretical model. Self-efficacy. Timepoint: Self-efficacy will be measured at baseline, immediately after the intervention, and 1 month after the intervention. Method of measurement: Self-efficacy will be assessed using the Sherer General Self-Efficacy Scale. This instrument evaluates individuals’ perceived ability to perform and maintain health-related behaviors. Islamic Azad University, Isfahan Branch (Khorasgan) Approved 2026-03-08 Research Ethics Committee, Islamic Azad University, Isfahan Branch (Khorasgan) Jey Sharqi Street, Arghavanieh, Daneshgah Boulevard, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan. Isfahan Isfehan Iran (Islamic Republic of)