Investigating the effect of educational therapy intervention based on the theory of planned behavior on self-care behaviors of people with type 2 diabetes

Determining the effect of educational intervention on self-care behaviors in patients with type 2 diabetes referring to comprehensive health centers in Khorramshahr city based on the theory of planned behavior

A randomized, single-blind, controlled clinical trial on 180 patients. Randomization by systematic randomization method.

This study will be a randomized multicenter trial. The statistical population will be patients with type 2 diabetes referred to urban, rural, and urban-rural comprehensive health service centers in Khorramshahr city in Khuzestan province. The clusters will be urban, rural, and urban-rural comprehensive health service centers in Khorramshahr city, and a maximum of 6 comprehensive health service centers (3 intervention, 3 control) will be randomly selected, and a total of 180 people will be included in the study. From each cluster or urban or rural comprehensive health center, 30 patients with type 2 diabetes will be randomly selected. Random selection of the sample will be done using the systematic randomization method.

Confirmed type 2 diabetes, absence of neurological diseases and learning disorders, and informed consent are conditions for participation in the study. Exclusion criteria were unwillingness to continue participating in the study, failure to attend half of the educational sessions, change of address and contact number, and death.

The educational intervention is only carried out in the intervention group, which includes a combination of in-person and virtual education for 3 weeks, and the control group receives only routine health care during the study period.

Knowledge, attitude, abstract norms, perceived behavioral control, behavioral intention, social support, diabetes-related behavior, fasting blood sugar

This study is a multicenter randomized trial. Its statistical population is patients with type 2 diabetes who refer to urban, rural, or urban-rural comprehensive health service centers in Khorramshahr city in Khuzestan province. The random sampling method is multistage. In this way, the selection of three urban, rural, or urban-rural comprehensive health service centers is done by simple random selection for the control group and three urban, rural, or urban-rural comprehensive health service centers for the intervention group. Upon visiting each center, first, the list of people covered by the center who have type 2 diabetes is provided as a sampling frame. From the aforementioned list, 30 people (main) and 30 alternative people (for cases where people do not have the same conditions or do not wish to participate in the project) are selected by systematic random sampling. This process continues for 6 centers until the final list of research units is achieved. Then, the randomization list for each center is provided to the researcher by a statistical specialist in order to allocate people to the intervention and control groups.

The type of blinding in this study is double-blind, meaning that first, the participants in the study do not know which group they belong to, and the intervention and control groups are unrelated because these two groups of diabetic patients are selected from separate centers. Second, the person performing the analysis does not know the details of the intervention and which group the people are assigned to.

No further information available.