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

Plain-language summary

This study examines the effect of a multicomponent intervention on cognitive function in pairs made up of older adults with mild cognitive impairment and their family caregivers. It enrolls people aged 55 and older with a diagnosis of mild cognitive impairment together with their primary family caregivers. It is a study without a designated phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Universidad de Santander

Intervention

Multi-component, transdisciplinary and multifocal intervention for the cognition

Start date

7/30/2024

Estimated completion

10/1/2026

Countries

Colombia

Related genes

Locations

• Bucaramanga, Colombia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion and exclusion criteria for elderly adults

Inclusion criteria

1. Age of 55 years or older.
2. Diagnosis of mild cognitive impairment by a Psychiatrist/Neurologist supported by neuropsychological evaluation.
3. Functionality for instrumental activities.
4. Basic proficiency in reading and writing.
5. Absence of untreated hearing impairment and/or uncorrected visual problems.
6. Availability of a primary family caregiver (to be identified).
7. IPAQ with low level of physical activity (pending cutoff point), PARQ and you Fit (pending review).
8. Barthel Index equal to or greater than 80 points.
9. Functional capacity for short-distance ambulation without permanent use of mechanical aids such as wheelchairs.
10. Individuals with a BMI greater than 18.5.
11. Gastrointestinal tract without surgical resections.
12. Tolerance to oral feeding.
13. Vaccination against COVID-19.

Exclusion criteria

1. History of psychosis or congenital intellectual disability.
2. Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury).
3. Presence of untreated psychiatric disorders, anxiety, depression (Yesavage).
4. Presence of clinically significant systemic diseases (thyroid dysfunction, vitamin B12 deficiency, insulin-dependent diabetes, syphilis, HIV infection, Epstein Barr infection, advanced stage renal failure, cirrhosis). Evaluated through medical history and self-report.
5. Older adult with Chronic Kidney Disease, Hepatopathies (hepatitis, liver cirrhosis),
6. Pulmonary Diseases, or requiring oxygen support, Crohn's Disease, and Colitis.
7. Individual with oncological pathology who has received or is receiving chemotherapy.
8. Individual who has received probiotics or prebiotics in the last 30 days.
9. Presence of clinically significant, active infectious etiology diarrhea.
10. Current or prior abuse of alcohol, tobacco, or drugs.
11. Use of steroids or immunosuppressants in the last 30 days.
12. Recent use of antibiotics, antifungals, or antivirals (excluding topicals) in the last 3 months.
13. Individual who voluntarily decides to withdraw from the study.
14. Older adult without oral, enteral, or parenteral nutritional support.
15. Poor tolerance to exercise, vertigo, medical exercise restriction.

Elimination criteria

1. Institutionalized or hospitalized for more than 1 week, or death during the intervention phase (review and clarity on death).
2. Failure to attend more than 34% of sessions with professional accompaniment (applies to the dyad).

Inclusion and exclusion criteria for caregivers ( Family members)

Inclusion criteria

1. Adults aged 18 years or older.
2. Basic proficiency in reading and writing.
3. Having a level of kinship (consanguineous or non-consanguineous).
4. Vaccination against COVID-19.