]>
IRCT20151003024312N8 IRCT 2025-09-14 Shahid Beheshti University of Medical Sciences Effectiveness of evidence-based nursing care on the quality of life, cognitive performance, and psychological well-being of middle-aged individuals with mild cognitive impairment 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 2025-10-23 anticipated 60 Recruiting https://irct.ir/trial/85654 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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, Blinding description: 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. N/A Mild cognitive impairment. Intervention 1: Intervention group: In the present study, evidence-based nursing care refers to a Nurse-led Cognitive Support Toolkit, which will first be designed using the Iowa Model for evidence translation into practice, and then finalized as a toolkit through reviewing intervention studies delivered in cognitive support clubs. After validation of the toolkit by five experts in the fields of geriatrics and mental health, it will be implemented over a 10-week period in the form of weekly two-hour virtual sessions via Google Meet, accompanied by daily delivery of cognitive support materials and/or games/podcasts. The Cognitive Support Club refers to the group of patient participants engaged through an agreed-upon social media platform, where discussions, cognitive support, and coordination of sessions will take place. Intervention 2: Control group: They will receive routine therapeutic and care interventions. Yes - There is a plan to make this available What will be shared: Raw and final dataset of the clinical trial When: Access will only be granted upon formal request and with ethics committee approval. To whom: 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. Conditions: 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. Where to obtain: 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]. How to obtain: 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. Comments:
public Yalda Malek
Opposite of the Rajaee Hospital, Valieart St.,
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 yalda.malek1380@gmail.com Shahid Beheshti University of Medical Sciences scientific Fataneh Ghadirian Baharanchi
Opposite of the Rajaee Hospital, Valieasr St.,
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8865 5366 ghadirian.fataneh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Individuals with mild cognitive impairment aged 40 to 65 years Meeting the Peterson criteria for diagnosing mild cognitive impairment of the amnestic type, either single-domain or multi-domain, as determined by the psychiatric nurse (researcher) Exclusion of dementia diagnosis based on self-reporting 40 years 65 years Both Inability to participate in digital platforms and social media Existing known psychiatric disorders in the history and currently based on self-reporting Existing substance abuse based on self-reporting Having severe debilitating physical disorders or diseases currently (such as severe heart diseases, cancer, stroke, etc.) based on self-reporting Having severe sleep disorders based on self-reporting F06.7 A condition characterized by cognitive decline that is greater than expected for a person's age and education level, but not severe enough to interfere significantly with daily life. Rehabilitation N/A Intervention group: In the present study, evidence-based nursing care refers to a Nurse-led Cognitive Support Toolkit, which will first be designed using the Iowa Model for evidence translation into practice, and then finalized as a toolkit through reviewing intervention studies delivered in cognitive support clubs. After validation of the toolkit by five experts in the fields of geriatrics and mental health, it will be implemented over a 10-week period in the form of weekly two-hour virtual sessions via Google Meet, accompanied by daily delivery of cognitive support materials and/or games/podcasts. The Cognitive Support Club refers to the group of patient participants engaged through an agreed-upon social media platform, where discussions, cognitive support, and coordination of sessions will take place. Control group: They will receive routine therapeutic and care interventions. Cognitive performance. Timepoint: During intervention and immediately after intervention. Method of measurement: Questionnaires, brief cognitive examination, and Montreal cognitive assessment. Psychological performance. Timepoint: During intervention and immediately after intervention. Method of measurement: The 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). Quality of life. Timepoint: During intervention and immediately after intervention. Method of measurement: World Health Organization Quality of Life Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2025-07-21 Faculties of Pharmacy, Nursing, and Midwifery – Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery, opposite Shahid Rajaei Heart Hospital, at the intersection of Valiasr Street and Ayatollah Hashemi Rafsanjani Highway. Tehran Tehran Iran (Islamic Republic of)