Cognitive Intervention for Cognitive Impairment
- Sponsor
- Instituto Mexicano del Seguro Social
- Study ID
- NCT07747675
- Status
- Not Yet Recruiting
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Conditions
- Cognitive Intervention
- Diabetes Mellitus
- Elderly Adults
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - 95 Years
- Healthy Volunteers
- Not accepted
Interventions
- cognitive intervention — OTHERThe intervention will be administered by two family medicine physicians trained in implementing the cognitive intervention. This intervention will utilize a cognitive-psychostimulation program based on INAPAM's Cognitive Stimulation Manual for Older Adults, which provides participants with tools for continuous stimulation, addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation.
Study Details
Mild cognitive impairment is characterized by cognitive dysfunction without impairment in instrumental activities of daily living, with aging being the primary risk factor. Cognitive interventions employ stimulation and training techniques to address this impairment. Objective: To determine the effect of a cognitive intervention on mild cognitive impairment in older adults with type 2 diabetes mellitus. Methods: A double-blind, randomized clinical trial involving 102 patients, who will be assigned to either a control group or an intervention group. Data collection will utilize a sociodemographic profile questionnaire and the Montreal Cognitive Assessment (MoCA). The cognitive intervention will be implemented over an average period of two months per subgroup, consisting of eight weekly, 60-minute sessions. Analysis will be conducted using descriptive statistics, and a linear mixed-effects model for repeated measures will be applied to evaluate the intervention's effect.
Key Dates
- First listed
- Aug 5, 2026
- Start date
- Aug 3, 2026
- Status verified
- Jul 2026
- Primary completion
- Sep 30, 2026
- Completion
- Oct 15, 2026
Study Design
- Enrollment
- 102 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Control groupThe control group will receive an intervention delivered by social work staff, involving the implementation of an Active and Healthy Aging program that includes cognitive rehabilitation workshops as well as physical, emotional, social, and functional stimulation, with the aim of providing rehabilitation to older adults in the emotional, functional, and cognitive domains.
- Experimental: Intervention gruopThe intervention will be administered by two family medicine physicians trained in implementing the cognitive intervention. This intervention will utilize a cognitive-psychostimulation program based on INAPAM's Cognitive Stimulation Manual for Older Adults, which provides participants with tools for continuous stimulation, addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation.
Primary Outcome Measure
Score on the MoCA scale [ Time Frame: Change from baseline (Week 0) to Week 8 ]
Central Contacts
- Erika L Vega Silva, Dr.449-918-0610
- Diana L García Zepeda, Dr.449-918-0610
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