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IRCT20240505061658N1 IRCT 2025-03-16 Yazd University of Medical Sciences Investigating the Impact of Cognitive Rehabilitation on Improving Cognitive Function in Older Adults Investigating the Impact of computer-based cognitive rehabilitation on cognitive function of older adults with diabetes and mild cognitive impairment 2025-05-10 anticipated 66 Complete https://irct.ir/trial/81278 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified randomization: To create equal entry conditions, an equal number of women and men will be assigned to each of the two intervention and control groups using a list created by SPSS software. Individuals eligible for study entry will be assigned to one of the two intervention and control groups based on this list, and the relevant interventions will be administered to that individual individually based on the intervention protocol. At the beginning of the study, the design partner will provide the principal investigator with envelopes containing the individuals' interventions in the order of entry into the study, based on the stratified random list created by the software, so that the assignment to the two groups remains hidden until the volunteer enters (allocation concealment), Blinding description: Due to the nature of the intervention, it is not possible to blind the researcher and participants. Data Analyst: Data for analysis are provided to the analyst in coded form without identifying group affiliation. The analyst only examines the raw data and is not informed of the allocation of participants. N/A Type 2 diabetes and Mild Cognitive Impairment. Intervention 1: Intervention group: The Attention and Memory Rehabilitation Program is an applied software that is part of the educational neuroscience intervention called Cognitive Rehabilitation Intervention. The principles of this program are for hierarchical organization of easier to more difficult tasks. Immediate receipt for initial correct responses and lengthening of the final points; Design of working memory functions including change, transfer and ability; Entertainment and presentation with emotional stimuli have been found to increase motivation and the tasks can be repeated to the desired extent. The decision to perform higher stages has been tested and in the image that he cannot respond to a stage up to 80%, that stage will be repeated and the presence of the therapist is required to upgrade the task level. In the “Calm” program, three main entertaining computer tasks are given to the participants: the unilateral face task to shift attention, the similar windows task and the house finding task to maintain stability. These tasks are graded and the level of their responses is increased. The grading is based on the number of stimuli, the speed of stimuli presented, the number of targets, and the change of role of the roles. Several studies have examined the effectiveness of this training package. Also, in the computer program for the rehabilitation of the ability and attention of "PRISA", the packaging task will be used to promote inhibition. This program was developed in 2019 at the Center for Cognitive Behavioral Neuroscience, Shahid Beheshti University. Its validity and reliability in Iran have been evaluated by Nejati and research has shown the effectiveness of this program. Intervention 2: Control group: General educational session about diabetes and disease management with pamphlet. Yes - There is a plan to make this available What will be shared: The data will be made available in anonymized form (without identifying information such as name, contact number or address). All data will be shareable after individuals are rendered non-identifiable. The protocol will be made available to other researchers in its entirety and without restriction. The clinical study report will be made available to other researchers after the study is completed and approved by the ethics committee. The statistical analysis plan will be made available to other researchers in its entirety. The data dictionary contains definitions and codes for the variables collected in the study. This file will be made available to other researchers in its entirety. When: Anonymized participant data will be available 6 months after the final study results are published in a reputable journal. To whom: Academic and scientific researchers, industrial researchers, governmental and non-governmental organizations, and students and independent researchers are permitted for research purposes and academic theses only. Conditions: Permitted purposes of using data and documents: Scientific research, theses and dissertations, policy and planning, technology development. Requirements for submitting an access request: Submitting a written request: Applicants must send their written request along with details of the research project to the official study email. Purposes of use: Applicants must clearly state the exact purposes of using the data and documents. Commitment to complying with research ethics: Applicants must provide a written commitment to comply with the principles of research ethics and confidentiality of information. Where to obtain: Send your application via email: Dr. Hassan Rezaei Pandari (Supervisor); Email: hrezaeipandari@yahoo.com How to obtain: Applicants must complete the following steps to receive study data and documentation. This process typically takes 7 to 14 business days. The details of each step are as follows: Step 1: Submit a written request Applicant Action: The applicant must submit a written request to hrezaeipandari@yahoo.com with the following information: First and last name Organizational affiliation (university, institute, organization, etc.) Project title or purpose of data use Ethics committee approval (if applicable) Duration: This step begins immediately after the email is sent. Step 2: Initial review of the request Research team action: The research team reviews the request for completeness of the information and compliance with the permitted purposes of use. Duration: This step typically takes 1 to 2 business days. Review result: If the request is initially approved, the request is forwarded to the next step. If additional information is required, the applicant will be asked to submit additional information. Step 4: Prepare and submit data/documents Research team action: Data and documents are anonymized and prepared in Excel/CSV (for data) and PDF (for documents) files. Duration: This step usually takes 1-2 business days. Delivery method: Data and documents are provided to the applicant via email or secure download link. Was. Overall process duration: Minimum time: 7 business days (if the application is complete and no additional information is needed) Maximum time: 14 business days Comments:
public Mohammadhossien Ahadi
Alam Square, Shohada Gomnams Blvd., Shahid Sadoughi University of Medical Sciences and Health Services Campus, School of Public Health, Yazd
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۶۰ +98 35 3820 9100 m.hossien.ahadi@gmail.com Yazd University of Medical Sciences scientific Hassan Rezaeipandari
Alam Square, Shohada Gomnams Blvd., Shahid Sadoughi University of Medical Sciences and Health Services Campus, School of Public Health, Yazd
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۶۰ +98 35 3820 9100 hrezaeipandari@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Elderly individuals aged 60 to 75 years Diagnosis of type 2 diabetes Willingness of the patient to participate in the study Scoring below 26 on the MoCA test Possessing basic literacy Ability to work with a computer Having a medical record at the diabetes center 60 years 75 years Both Presence of diabetic foot ulcers Absence from at least two intervention sessions Use of medications affecting cognitive status Hospitalization Stroke Development of severe diabetic complications (such as the need for dialysis, complete blindness, or severe disability) that hinder proper implementation of the intervention and tests Presence of any medical or psychiatric condition that prevents the elderly individual from continuing participation in the study Rehabilitation Rehabilitation Intervention group: The Attention and Memory Rehabilitation Program is an applied software that is part of the educational neuroscience intervention called Cognitive Rehabilitation Intervention. The principles of this program are for hierarchical organization of easier to more difficult tasks. Immediate receipt for initial correct responses and lengthening of the final points; Design of working memory functions including change, transfer and ability; Entertainment and presentation with emotional stimuli have been found to increase motivation and the tasks can be repeated to the desired extent. The decision to perform higher stages has been tested and in the image that he cannot respond to a stage up to 80%, that stage will be repeated and the presence of the therapist is required to upgrade the task level. In the “Calm” program, three main entertaining computer tasks are given to the participants: the unilateral face task to shift attention, the similar windows task and the house finding task to maintain stability. These tasks are graded and the level of their responses is increased. The grading is based on the number of stimuli, the speed of stimuli presented, the number of targets, and the change of role of the roles. Several studies have examined the effectiveness of this training package. Also, in the computer program for the rehabilitation of the ability and attention of "PRISA", the packaging task will be used to promote inhibition. This program was developed in 2019 at the Center for Cognitive Behavioral Neuroscience, Shahid Beheshti University. Its validity and reliability in Iran have been evaluated by Nejati and research has shown the effectiveness of this program. Control group: General educational session about diabetes and disease management with pamphlet Improvement in working memory performance, improved selective attention, and improved inhibitory control. Timepoint: Measurement of cognitive performance score at the beginning of the study and after the intervention. Method of measurement: Selective attention variable with Stroop test, Working Memory variable with N-back test, and Inhibitory Control variable with Go-No-Go test. Overall cognitive performance score. Timepoint: At the beginning of the study and immediately after the end of the intervention. Method of measurement: Cognitive performance score on the MOCA test. Yazd University of Medical Sciences Approved 2025-03-01 Faculty of Public Health - Shahid Sadoughi University of Medical Sciences, Yazd Alam Square, Shohada-ye Gomnami Blvd, Shahid Sadoughi University of Medical Sciences and Health Services Campus, School of Public Health, Yazd Yazd Yazd Iran (Islamic Republic of)