Assessing the effect of evidence-based nursing care on the quality of life, cognitive performance, and psychological well-being of middle-aged individuals with mild cognitive impairment

Determining the impact of evidence-based nursing care based on Iowa model on the quality of life, cognitive function, and psychological well-being of middle-aged individuals with mild cognitive impairment

The clinical trial will include a control group, with parallel groups, single-blind, employing a pretest–posttest design, with a total sample size of 60 participants, who will be systematically randomized into two intervention groups (30 participants) and one control group (30 participants).

After obtaining written consent from the participants, demographic, clinical, cognitive, psychological, and baseline quality of life information (T0) will be collected. The intervention will be conducted for 10 weeks for the intervention group, while the control group will receive the training at the end of the study. This study will be conducted at all healthcare centers under the supervision of Shahid Beheshti University of Medical Sciences.

Inclusion criteria: Individuals with mild cognitive impairment aged 40 to 65 years. Ability to participate in digital platforms and social media. Informed consent from individuals to participate in the research. No known psychiatric or physical disorders and no substance abuse based on self-reporting. Exclusion criteria: occurrence of unexpected family events or withdrawal from the study.

In this study, evidence-based nursing care based on Iowa model will be designed and developed after reviewing relevant studies, and after its validity is confirmed by five specialists in geriatrics and mental health, it will be implemented over a 10-week period through virtual sessions lasting two hours (once a week) using Google Meet.

Cognitive performance, psychological performance, and quality of life.

Sampling will be conducted using a multistage method. In the first stage, the sampling center will be selected from among the comprehensive health service centers affiliated with Shahid Beheshti University of Medical Sciences through a non-random and convenience sampling approach. Within each center, individuals will be randomly allocated to the intervention and control groups. Specifically, based on the contact information extracted from the health records (SIB system), individuals who meet the study inclusion criteria will be identified and selected from the list using a systematic random sampling method (every other individual). This process will continue until the required sample size in each group is reached. In cases where a selected individual declines participation, a replacement sample will be chosen from the same list according to the same systematic random sampling method. Furthermore, to determine randomly whether the first individual is allocated to the intervention or control group, a lottery method will be applied.

The single-blind design means that the statistical analyst is unaware of the group allocation of the participants, which is intended to reduce bias in the data analysis process.

Raw and final dataset of the clinical trial

Access will only be granted upon formal request and with ethics committee approval.

The data and documents related to the study will be accessible exclusively to researchers and members of the scientific community with legitimate research purposes. Access is contingent upon adherence to ethical guidelines, confidentiality agreements, and approval by the ethics committee.

Data and documents may only be used for legitimate scientific research purposes and must comply with ethical standards. Applicants are required to submit a research proposal and commit to maintaining confidentiality and respecting participant rights. Use of the data is contingent upon approval by the ethics committee and written consent from the study’s principal investigators.

The data and documents related to the study will be obtainable from the Shahid Beheshti University of Medical Sciences data repository as well as email at [ghadirian.fataneh@gmail.com].

Applicants must submit a formal request including their research objective, study proposal, and a commitment to confidentiality. The request will be reviewed by the research team and the ethics committee. Upon approval, access will be granted under specific and restricted conditions. Applicants are also required to sign a data use agreement, pledging to use the data solely for the stated purposes.