Clinical trial NCT06408103: Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Official title: Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Rehabilitation
Informal caregiver
Transdisciplinary intervention
Multi-component intervention
Cognitive dysfunction
Lead sponsor: Universidad de Santander
Sponsor class: OTHER
Collaborators: name: Universidad Manuela Beltrán
name: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
name: Universidad Autónoma de Bucaramanga
name: Universidad Santo Tomas
name: Ministerio de Ciencia Tecnología e Innovación - Minciencias
First posted: 2024-05-09
Enrollment: 102
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in global cognition
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in global cognition
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in verbal learning and memory
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in processing speed and visual attention
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in visual attention, thinking speed, and visuospatial ability
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in executive functioning and selective attention
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in perceptual organization and visual memory
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in verbal fluency and executive functions
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in comprehension and expression levels
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: change in verbal comprehension
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change WAIS III Digit Retention
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
Secondary outcomes:
measure: Change in patient independence
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in physical frailty
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in nutritional status
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in mobility and balance
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Changes in functional capacity and physical condition
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in the composition of the microbiome
timeFrame: 3 months after the intervention
measure: Change in family caregiver overload
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in Social Support for Family Caregiver
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
measure: Change in quality of life in the dyad
timeFrame: 3 months after the intervention, with follow-up at 6 and 9 months
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Universidad de Santander / Universidad Manuela Beltrán /FOSCAL
state: Santander
Study officials:
affiliation: Universidad de Santander
name: Diana Tiga Loza
role: STUDY_DIRECTOR
References: