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.
Potential participants will be evaluated in Education Classroom 1 at UMF No. 7. After obtaining written informed consent, two instruments will be administered to the patients. First, a questionnaire gathering sociodemographic characteristics will be administered. The second measurement instrument will be the Montreal Cognitive Assessment (MoCA). Randomization and assignment: Eligible participants will be assigned via simple random selection in a 1:1 ratio using a computer-generated block randomization sequence. Group assignment will be concealed using opaque, sealed, and sequentially numbered envelopes managed by an independent study coordinator who is not involved in patient care or assessment. Intervention phase (weeks 1 to 8): Group 1 (intervention) will receive the intervention based on the cognitive psychostimulation program outlined in the INAPAM Cognitive Stimulation Manual for Older Adults. Group 2 (control): Patients will receive an intervention delivered by social work staff, consisting of an Active and Healthy Aging program. Upon completion of the intervention, the MoCA scale will be administered again to evaluate the effectiveness of the implemented program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
102
The 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.
Score on the MoCA scale
Assessed using the MoCA scale (range of 0 to 30 points). Results are classified as follows: 0-25 points indicate mild cognitive impairment, while 26-30 points are considered normal.
Time frame: Change from baseline (Week 0) to Week 8
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