Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408103
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-05
Brief Title:
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Sponsor:
Universidad de Santander
Organization:
Universidad de Santander
Study Overview
Official Title:
Efficacy of a Multicomponent Intervention on Cognitive Function for the Caregiver-patient Dyad
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERCOG
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
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 11 allocation in 102 patients with mild cognitive impairment and their primary caregiversfamily 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
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 11 allocation in 102 patients with mild cognitive impairment and their primary caregiversfamily 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None