Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

With the aging of the population, an increase in neurocognitive diseases such as dementia is projected. Mild cognitive impairment is considered a precursor stage to dementia, with opportunities for intervention to prevent its progression. Additionally, these illnesses can harm the primary caregiver, who is often an unskilled family member. This is a randomized clinical trial in patients with mild cognitive impairment and their main caregivers. The intervention will be tested in the dyad for 12 weeks, twice a week with professional support and once a week with caregiver support, the latter will be intervened once a week for 12 weeks. The primary outcome will be the change in cognitive function and its domains. Secondary outcomes will evaluate favorable changes in quality of life in the patient-caregiver couple, frailty, physical capacity, independence, nutritional status, social support, and family caregiver burden. These measurements will be taken at baseline, 3, 6, and 9 months of follow-up. Furthermore, in a subsample of the study population, the taxonomic and metabolomic composition of the intestinal microbiota and the presence of the E4 allele of the APOE (apolipoprotein E) gene will be evaluated before and after the intervention.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• Age of 55 years or older.

• Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation.

• Functionality for instrumental activities.

• Basic proficiency in reading and writing.

• Absence of untreated hearing impairment and/or uncorrected visual problems.

• Availability of a primary family caregiver (to be identified).

• IPAQ with low level of physical activity (pending cutoff point), PARQ and you Fit (pending review).

• Barthel Index equal to or greater than 80 points.

• Functional capacity for short-distance ambulation without permanent use of mechanical aids such as wheelchairs.

⁃ Individuals with a BMI greater than 18.5.

⁃ Gastrointestinal tract without surgical resections.

⁃ Tolerance to oral feeding.

⁃ Vaccination against COVID-19.

• Adults aged 18 years or older.

• Basic proficiency in reading and writing.

• Having a level of kinship (consanguineous or non-consanguineous).

• Vaccination against COVID-19.

Locations
Other Locations
Colombia
Universidad de Santander / Universidad Manuela Beltrán /FOSCAL
RECRUITING
Bucaramanga
Contact Information
Primary
Diana Tiga Loza, Ph.D
dia.tiga@mail.udes.edu.co
+57 (607) 6516500
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2025-11
Participants
Target number of participants: 102
Treatments
Experimental: Multi-component, transdisciplinary and multifocal intervention (intercog-group)
This group will receive a multi-component intervention that includes cognitive training, physical exercise, and nutritional counseling; dually and simultaneously. This intervention will be carried out at the patient's home for 12 weeks, with professional support twice a week plus a recommendation to walk 30 minutes/day.~Furthermore, in the family component, caregivers of the patients will also receive a training component to accompany the intervention and prepare for the caregiver role. This component will be delivered by healthcare professionals in a group format (n=10 per group) over 12 weeks, with weekly sessions lasting 2 hours each. Each session is organized into five parts: opening, activation, education, practice, and explanation of the activities for the next week.
No_intervention: Usual care plus active control
The conventional management of patients with mild cognitive impairment focuses on therapies such as cognitive rehabilitation, occupational therapy, and physical exercise, with medical monitoring as needed according to the patient's needs. Additionally, they will receive information about infectious diseases such as dengue, pneumonia, tuberculosis, Chagas disease, leishmaniasis, COVID-19, leprosy, urinary tract infection, rabies, superficial and cutaneous mycoses, and hepatitis one topic per week through an infographic and video sent to the cell phone.
Related Therapeutic Areas
Sponsors
Collaborators: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle, Universidad Manuela Beltrán, Universidad Santo Tomas, Universidad Autónoma de Bucaramanga, Ministerio de Ciencia Tecnología e Innovación - Minciencias
Leads: Universidad de Santander

This content was sourced from clinicaltrials.gov