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

NCT06408103 | Recruiting DMC

• 1 other identifier: CTO 652-21
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Rehabilitation; Informal caregiver; Transdisciplinary intervention; Multi-component intervention; Cognitive dysfunction

Outcome Measures

Primary Outcomes (11)

• Change in global cognition

  It will be evaluated by Mini Mental State Examination (MMSE). The scale evaluates the dimensions of orientation, memory, attention and calculation, memory, and language. It has a score of 0 to 30 points and can be categorically interpreted as follows: between 30 and 27 points: No cognitive impairment. Between 26 and 25 points: Possible cognitive impairment. Between 24 and 10 points: mild to moderate cognitive impairment. Between 9 and 6 points: moderate to severe cognitive impairment. Less than 6 points: Major cognitive impairment.

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in global cognition

  It will be evaluated by the Montreal Cognitive Assessment (MoCA). The scale evaluates 6 domains: visuospatial ability, executive function, memory, attention/concentration, language, and orientation. It has a scoring scale from 0 to 30, with the following interpretation: 26 or more: No cognitive impairment. 20 to 23: Mild Cognitive Impairment. Score less than 10: major neurocognitive disorder

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in verbal learning and memory

  The change in verbal learning and memory will be assessed using the Hopkins Verbal Learning Test (HVLT). It consists of 12 words grouped into three semantic categories. In the population aged between 56 and 76 years, the mean total recall is 18.6 with a standard deviation of 4.6, while for delayed recall, the mean is 6.1 with a standard deviation of 2.4

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in processing speed and visual attention

  The change in processing speed and visual attention will be evaluated using the Symbol Digit Modalities Test (SDMT). This test assesses two domains: processing speed and sustained attention. In the population aged between 56 and 76 years, the mean score is 27 (12.1)

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in visual attention, thinking speed, and visuospatial ability

  The change in visual attention, thinking speed, and visuospatial ability will be evaluated using the Trail Making Test (TMT-Form A, TMT-Form B). Interpreting the results involves comparing completion times of these forms with normative data corresponding to the same age group. For context, the mean completion times for TMT-A and TMT-B in the population aged 56 to 75 years are as follows: 75.8 seconds (with a standard deviation of 22.8 seconds) for TMT-A and 178 seconds (with a standard deviation of 80.7 seconds) for TMT-B.

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in executive functioning and selective attention

  The Color and Word Test assesses executive functioning and selective attention, measuring processing speed and the ability to focus on relevant stimuli while discarding distractors. It also examines cognitive control, inhibition and resistance to cognitive interference. The mean scores for 'Word', 'Color', 'Word-Color' and 'Interference' are 77.7 (standard deviation 21.8), 55.5 (standard deviation 16.6), 30.8 (standard deviation 11.6) and -1.4 (standard deviation 9.1) respectively, reflecting the cognitive abilities of the tested group.

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in perceptual organization and visual memory

  The change in perceptual organization and visual memory will be assessed through the Rey Complex Figure Test. This test is divided into 18 elements, each of which scores 2 if the execution is correct; if there is a mistake in the placement or tracing of the element, 1 point is awarded, and if both the placement and tracing are incorrect (or the element is absent), 0 points are awarded. Thus, the total possible score varies between 0 and 36. Two sets of scores are obtained: one for immediate copy and another for long-term recall. In the age group of 56 to 76 years, the mean score for the copying task is 27.9 with a standard deviation of 7.4, while for long-term memory, the mean is 13.7, also with a standard deviation of 7.4

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in verbal fluency and executive functions

  Change in verbal fluency and executive functions will be assessed through the Semantic and Phonological Verbal Fluency Test. This test evaluates the ability to generate words following specific semantic or phonological criteria. Scores are assigned based on semantic category and the initial letter of words. For the letter "F," the mean is 9.9 with a standard deviation of 4.3; for "A," the mean is 10.1 with a standard deviation of 4.4; and for "S," the mean is 9.6 with a standard deviation of 4.4. In semantic categories, "ANIMALS" has a mean of 15.6 with a standard deviation of 4.5, while "FRUITS" has a mean of 13 with a standard deviation of 3.7. These scores reflect the quantity and variety of words individuals can produce and are indicative of their linguistic ability and executive capacity

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in comprehension and expression levels

  The change in the levels of verbal naming and expression will be assessed from the BOSTON Naming Test. In the age group 56 to 76 years, the mean score for the copying task is 42.8 with a standard deviation of 8

  3 months after the intervention, with follow-up at 6 and 9 months

• change in verbal comprehension

  TThe Token Test will be used to assess verbal comprehension. This test specifically measures skills related to listening comprehension and the ability to follow instructions. As for the cut-off points for the different ages, they are set as follows: 50 to 56 years (31.5-32), 57 to 59 years (32-32.5), 60 to 68 years (32-32.5), 69 to 71 years (31-31.5), 72 to 74 years (31.5-32.5).

  3 months after the intervention, with follow-up at 6 and 9 months

• Change WAIS III Digit Retention

  It is designed to evaluate attention and working memory. It consists of a total of 8 items distributed in two trials. This task is divided into two parts: one that requires repeating the numbers in the order in which they are presented (direct order) and another in the reverse order. For individuals between 50 and 71 years of age, the cut-off points for correct retention are 4 in the direct order and 3 in the reverse order. These thresholds indicate the minimum number of digits that the individual must remember correctly to be considered within a normal range of functioning in each task modality

  3 months after the intervention, with follow-up at 6 and 9 months

Secondary Outcomes (9)

• Change in patient independence

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in physical frailty

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in nutritional status

  3 months after the intervention, with follow-up at 6 and 9 months

• Change in mobility and balance

  3 months after the intervention, with follow-up at 6 and 9 months

• Changes in functional capacity and physical condition

  3 months after the intervention, with follow-up at 6 and 9 months

Study Arms (2)

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

EXPERIMENTAL

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.

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

Usual care plus active control

NO INTERVENTION

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.

Interventions

Multi-component, transdisciplinary and multifocal intervention for the cognition OTHER

Multi-component intervention (12 weeks, twice/week, with professional support at home) Physical activity for the patient: dual training, strength, balance, with intensity increase monthly, plus moderate walking of 30 minutes/day, 5 days per week. Nutritional advice for the patient: Month 1- reduction of added sugars and processed carbohydrates. Month 2- increase consumption of healthy fats and reduction of saturated fats; Month 3- increase in consumption of fruits and vegetables, and a monthly group practical workshop. Cognitive training for the patient: activities focused on orientation, attention and concentration, working memory, mathematical reasoning, language, visual construction, executive functions, and reminiscence therapy. Accompaniment for the family member: Activities aimed at care and self-care, understanding cognitive deterioration and its progression, support for patient adherence to the intervention, and activities in groups once a week.

Also known as: INTERCOG

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

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• History of psychosis or congenital intellectual disability.
• Presence of a central nervous system pathology that could affect cognition (Parkinson's disease, tumors, encephalitis, epilepsy, cerebrovascular disease, traumatic brain injury).

Sponsors & Collaborators

• Universidad de Santander: lead
• Universidad Manuela Beltrán: collaborator
• Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle: collaborator
• Universidad Autónoma de Bucaramanga: collaborator
• Universidad Santo Tomas: collaborator
• Ministerio de Ciencia Tecnología e Innovación - Minciencias: collaborator

Study Sites (1)

Universidad de Santander / Universidad Manuela Beltrán /FOSCAL

Bucaramanga, Santander Department, 62215, Colombia

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Diana Tiga Loza

  Universidad de Santander

  STUDY DIRECTOR

Central Study Contacts

Diana Tiga Loza, Ph.D

CONTACT

+57 (607) 6516500; dia.tiga@mail.udes.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluators responsible for data collection will not have knowledge of the cognitive status or the assignment of participants to study groups. Additionally, the person responsible for subjecting the data to different statistical tests will not be aware of the participants' assignment to the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiology Ph.D

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: May 9, 2024
• Study Start: July 30, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-05

Locations

CO (1)