Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488430
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-18
Brief Title:
Mild Cognitive Impairment and Multidomain Intervention Package
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Mild Cognitive Impairment Among Community Dwelling Adults Prevalence Associated Factors and Feasibility of a Multidomain Intervention Package for Preventing Cognitive Decline
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The state of Kerala India has the highest proportion of older adults and the burden of lifestyle diseases causes great concern Therefore there is need for identifying a feasible multidomain preventive intervention to ease this burden Initially the burden of mild cognitive impairment will be determined as this information is scarce from the setting A multidomain intervention package will be developed that is appropriate for the setting The adherence rates barriers and facilitators will be assessed If the multidomain intervention is found feasible it can be recommended for further clinical trials
Detailed Description:
In the context of increasing older adults the burden of dementia is forecasted to increase in India Interventions targeting risk factors and diseases may be the key element to counter the dementia epidemic The state of Kerala having highest proportion of older adults and burden of lifestyle diseases in India causes even greater concern Hence there is need for identifying the burden of mild cognitive impairment developing a feasible multidomain preventive intervention to be applied among older adults to prevent cognitive decline
Objectives
1 To estimate the burden of mild cognitive impairment among community dwelling adults between 50-65 years in a taluk of a South Kerala district
2 To develop a multidomain intervention package for preventing cognitive decline in those with mild cognitive impairment
2 To explore the barriers and facilitators for adherence towards multidomain intervention to prevent cognitive decline in community dwelling older adults between 50- 65 years with mild cognitive impairment in the study area Recruitment The sampling area consists of 54 wards 39 rural and 15 urban from Tiruvalla Taluk of Pathanamthitta district A ward is a division of the community at the local government level with approximately 300-500 families and an elected government representative from the community known as ward member From these wards 15 rural and 5 total 20 wards urban wards will be randomly picked From each ward 24 eligible participants will be randomly picked from all the wards one extra person from the last ward in order to reach the sample size ASHA workers will help the team to identify the eligible candidates The ASHA workers and the ward members will communicate to the community regarding the study which would help the research team to build a rapport with the community The research team will explain the details of the study and consent form to the potential participants Identified consented adults 50- to 65-year-old will be screened using the study tool to identify those with mild cognitive impairment
Screening All individuals 50-65yrs consenting to participate will be included Those who are unable to respond critically ill and with a diagnosis of dementia physician diagnosed will be excluded MCI in the study will be assessed using the European Alzheimers Disease Consortium Participants who meet all the five criteria of this definition will be defined as MCI cases
Enrollment Twenty participants found to have MCI will be enrolled in to a pilot study to explore the barriers and facilitators of adherence towards the intervention package The inclusion and exclusion criteria has been detailed earlier All those with MCI from a ward will be included If adequate number is not available in a ward rest of the participants will be taken from the adjacent ward
Intervention A multidomain intervention will be developed and will be pilot tested for adherence for a period of one month The intervention includes nutritional advice physical activity cognitive stimulation therapy social engagements and management of vascular risk factors
Assessment The cognitive ability depression activities of daily living quality of life will be assessed during the screening phase by using standard questionnaires validated in the local language The adherence towards the individual and group activities in the intervention will be assessed using checklists In-depth interviews will be conducted to understand the barriers and facilitators towards adherance
Followup The research team will assess the adherence towards intervention using checklists In depth interviews will be done to identify the barriers and facilitators towards adherence
Objectives
1 To estimate the burden of mild cognitive impairment among community dwelling adults between 50-65 years in a taluk of a South Kerala district
2 To develop a multidomain intervention package for preventing cognitive decline in those with mild cognitive impairment
2 To explore the barriers and facilitators for adherence towards multidomain intervention to prevent cognitive decline in community dwelling older adults between 50- 65 years with mild cognitive impairment in the study area Recruitment The sampling area consists of 54 wards 39 rural and 15 urban from Tiruvalla Taluk of Pathanamthitta district A ward is a division of the community at the local government level with approximately 300-500 families and an elected government representative from the community known as ward member From these wards 15 rural and 5 total 20 wards urban wards will be randomly picked From each ward 24 eligible participants will be randomly picked from all the wards one extra person from the last ward in order to reach the sample size ASHA workers will help the team to identify the eligible candidates The ASHA workers and the ward members will communicate to the community regarding the study which would help the research team to build a rapport with the community The research team will explain the details of the study and consent form to the potential participants Identified consented adults 50- to 65-year-old will be screened using the study tool to identify those with mild cognitive impairment
Screening All individuals 50-65yrs consenting to participate will be included Those who are unable to respond critically ill and with a diagnosis of dementia physician diagnosed will be excluded MCI in the study will be assessed using the European Alzheimers Disease Consortium Participants who meet all the five criteria of this definition will be defined as MCI cases
Enrollment Twenty participants found to have MCI will be enrolled in to a pilot study to explore the barriers and facilitators of adherence towards the intervention package The inclusion and exclusion criteria has been detailed earlier All those with MCI from a ward will be included If adequate number is not available in a ward rest of the participants will be taken from the adjacent ward
Intervention A multidomain intervention will be developed and will be pilot tested for adherence for a period of one month The intervention includes nutritional advice physical activity cognitive stimulation therapy social engagements and management of vascular risk factors
Assessment The cognitive ability depression activities of daily living quality of life will be assessed during the screening phase by using standard questionnaires validated in the local language The adherence towards the individual and group activities in the intervention will be assessed using checklists In-depth interviews will be conducted to understand the barriers and facilitators towards adherance
Followup The research team will assess the adherence towards intervention using checklists In depth interviews will be done to identify the barriers and facilitators towards adherence
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |