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

Universidad de Santander

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Other: Multi-component, transdisciplinary and multifocal intervention for the cognition

Study type: Interventional

Funder types: Other

Identifiers

NCT06408103

CTO 652-21

Details and patient eligibility

About

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.

Full description

Introduction: The aging of the population has led to an increase in the number of individuals with cognitive impairment and neurodegenerative diseases, resulting in greater disability and dependence among older adults worldwide. The prevalence of Mild Cognitive Impairment (MCI) is estimated to be approximately 16%, varying between 2% and 31%.

Multiple interventions have been tested to maintain or improve cognitive function in older adults, including cognitive-motor interventions, yoga, psychosocial and lifestyle interventions, as well as arts-based interventions (dance, theater, music, or visual arts). However, the literature indicates that multicomponent interventions (MCI), also known as multimodal or multidomain, are more effective compared to single-domain interventions in improving cognitive function in older adults.

General Objective: To evaluate the effectiveness of a multicomponent intervention focusing on cognitive function for the caregiver-patient dyad

Methods: Pilot randomized clinical trial, with 1:1 allocation in 102 patients with mild cognitive impairment and their primary caregivers/family members.

Results: The goal is to generate evidence on the efficacy and applicability of these interventions to create a care guide for the caregiver-patient dyad with cognitive impairment, tailored to the Colombian population, with the involvement of different institutions such as universities and healthcare providers.

Enrollment: 102 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Multi-component, transdisciplinary and multifocal intervention (intercog-group)

Experimental group

Description:

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.

Treatment:

Other: Multi-component, transdisciplinary and multifocal intervention for the cognition

Usual care plus active control

No Intervention group

Description:

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.