Cognitive Intervention, Diabetes Mellitus, Elderly Adults, Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Cognitive intervention, Elderly adults, Diabetes Mellitus
Brief summary
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.
Detailed description
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.
Interventions
OTHERcognitive intervention
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.
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, two-arm, parallel-group design with a total duration of 8 weeks. The Intervention Group will receive weekly cognitive-psychostimulation sessions based on the INAPAM Cognitive Stimulation Manual for Older Adults, providing participants with tools for continuous stimulation-addressing memory, attention, language, executive and visuospatial functions, abstraction, and orientation, while the Control Group will receive an intervention delivered by social work staff. This intervention will implement an Active and Healthy Aging program featuring 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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with disabling hearing and/or visual impairments, patients with paralysis, and patients with severe psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on the MoCA scale | Change from baseline (Week 0) to Week 8 | 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. |
Contacts
CONTACTErika L Vega Silva, Dr.
CONTACTDiana L García Zepeda, Dr.
PRINCIPAL_INVESTIGATORErika L Vega Silva, Dr.
Instituto Mexicano del Seguro Social
Outcome results
None listed