Cognitive Intervention for Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-95
SponsorInstituto Mexicano del Seguro Social
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Affiliation with IMSS Aguascalientes Family Medicine Unit (UMF) No. 7; age 65 to 95 years; male or female; known diagnosis of type 2 diabetes mellitus; any level of education; any occupation; presence of mild cognitive impairment; availability to attend cognitive intervention sessions; and signing of informed consent.
Disqualifiers
Patients with disabling hearing and/or visual impairments, patients with paralysis, and patients with severe psychiatric illness.
Trial design
Design model
Parallel
Treatments tested in this trial
cognitive intervention
Other interventionThe 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Intervention gruopExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 8Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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