The Effect of a Lifestyle Educational Intervention on Self-Care Behaviors in Patients with Hypertension: Application of the Continuous Care Model

Determining the effect of a lifestyle educational intervention on self‑care behaviors in patients with hypertension: application of the Continuous Care Model

A concealed, randomized, single-blind, controlled trial with a parallel group design of 88 patients with primary hypertension, enrolled by cluster randomization with lottery and individual selection by random number table, and followed for the non‑pharmacological study period.

This cluster‑randomized trial in Qom health centers allocates four centers (clusters) by lottery to intervention or control (two centers each). The intervention group receives lifestyle education in four phases (orientation, sensitization, control, evaluation); the control group receives routine care. Eligible lower‑quartile self‑care hypertension patients are randomly selected after cluster allocation. Outcomes are measured at pre‑intervention, immediately post, and three months post; participants and providers are unblinded, but assessors and analysts are blinded.

Eligibility criteria included adults aged 30–65 with primary hypertension, at least one year of disease history, and an active SIB record. After screening, participants with lower self-care scores who provided consent were enrolled. Exclusion criteria:conditions affecting participation, concurrent trials, and safety or logistical limitations

ntervention group: Participants receiving a lifestyle-based educational intervention grounded in the Continuous Care Model, based on the findings of the descriptive–analytical phase to improve self-care behaviors. Control group: Participants receiving routine care provided by comprehensive health service centers without receiving the study educational intervention.

Mean score of self‑care behaviors based on the standardized self‑care questionnaire

Cluster randomization with simple random allocation will be used in this study. The unit of randomization will be the selected Comprehensive Health Service Centers, and each center will be considered as a cluster. Block randomization, stratified randomization, and other quasi-random methods will not be used in this study. Upon completion of the descriptive analytical phase, four selected centers will enter the intervention phase. A numerical identifier will be assigned to each center, and the identifiers will be written on identical and indistinguishable slips of paper. The slips will then be placed in a sealed container by an individual independent of the research team, and two identifiers will be randomly drawn. The centers corresponding to these two identifiers will be allocated to the intervention group, while the remaining two centers will be allocated to the control group. Accordingly, the random allocation sequence for assigning clusters to the study groups will be generated. All data from the descriptive analytical phase, including self-care scores, will be collected prior to the randomization process. Therefore, researchers will not be aware of the future allocation of centers to the study groups at the time of baseline data collection. Following cluster allocation, eligible participants for the intervention phase will be identified based on the self-care scores recorded during the descriptive–analytical phase. For this purpose, self-care scores within each center will be ranked separately, and individuals whose scores fall within the lower quartile of the self-care score distribution in the same center will be considered eligible for inclusion in the intervention phase. Subsequently, 44 participants will be selected from the eligible individuals in each group using a random number table generated by SPSS version 27. To ensure allocation concealment, generation of the random sequence and allocation of centers to the study groups will be performed by an individual independent of the research team, and the allocation results will be kept by that individual until the group assignment process has been finalized. In addition, the outcome assessor and the data analyst will be blinded to group allocation.

To reduce bias in this study, blinding will be implemented at the level of outcome assessors and data analysts. Outcome assessors responsible for post-intervention data collection will not be aware of the allocation of clusters to the intervention and control groups. In addition, the data will be provided to the statistical analyst in a coded form, and the analyst will also be blinded to group identities. Due to the educational nature of the intervention and the cluster design of the study, blinding of participants, clinical caregivers, and intervention implementers will not be feasible.

Due to the sensitive nature of participants’ personal information and the principle of confidentiality in clinical research, anonymized individual participant data (IPD) from this study will not be made available to other researchers or the public.