An Intergenerational, Cognitively Enriched Intervention for MCI Patients and Their Children. (MCI-project)

An Intergenerational, Cognitively Enriched Lifestyle Intervention for Patients With a Mild Cognitive Impairment (MCI) and Their Children.

In 2018, approximately 50 million people received a diagnosis of dementia, which is projected to triple by 2050. To mitigate the increase in dementia, it is crucial to prevent cognitive decline in at risk groups, such as older adults with mild cognitive impairment (MCI). Recent research has demonstrated that combining physical (PA) and cognitive activities yields positive effects on the cognitive health of older adults. However, it is essential to explore effective ways of implementing this approach for MCI patients as it may help prevent dementia. An intergenerational program offers a novel and innovative method to achieve this goal by involving both older and younger generations in a single (exercise) program aimed at promoting the health behavior of both groups. Engaging children in an intergenerational, cognitively enriched exercise program for MCI patients primarily benefits the older adults while also providing advantages for the adult children. Therefore, this intergenerational project serves as a valuable and motivating force to enhance the physical, cognitive, and psychosocial health of MCI patients, with a secondary aim of positively impacting the adult children.

Phase 1 of this project (=current study) involves developing the intergenerational, cognitively enriched exercise program. This will be accomplished using a theoretical framework in combination with a co-creation approach, which actively involves MCI patients in the intervention development. Ten thinkaloud interviews (lasting approximately 2 hours) will be conducted with MCI patients and one of their adult children. The insights gained from these interviews will be used to adapt an existing exercise intervention for MCI patients according to their specific needs. Prior to the interview, participants will also be asked to complete a short questionnaire that collects basic demographic information.

Study Overview

• Status: Enrolling by invitation
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: No intervention, interviews with MCI patients as part of the development phase

Detailed Description

In 2018, approximately 50 million people received a diagnosis of dementia, which is projected to triple by 2050. To mitigate the increase in dementia, it is crucial to prevent cognitive decline in at risk groups, such as older adults with mild cognitive impairment (MCI). Recent research has demonstrated that combining physical (PA) and cognitive activities yields positive effects on the cognitive health of older adults. However, it is essential to explore effective ways of implementing this approach for MCI patients as it may help prevent dementia.

An intergenerational program offers a novel and innovative method to achieve this goal by involving both older and younger generations in a single (exercise) program aimed at promoting the health behavior of both groups. Engaging children in an intergenerational, cognitively enriched exercise program for MCI patients primarily benefits the older adults while also providing advantages for the adult children. Therefore, this intergenerational project serves as a valuable and motivating force to enhance the physical, cognitive, and psychosocial health of MCI patients, with a secondary aim of positively impacting the adult children.

Phase 1 of this project (=current study) involves developing the intergenerational, cognitively enriched exercise program. This will be accomplished using a theoretical framework in combination with a co-creation approach, which actively involves MCI patients in the intervention development. Ten thinkaloud interviews (lasting approximately 2 hours) will be conducted with MCI patients and one of their adult children. The insights gained from these interviews will be used to adapt an existing exercise intervention for MCI patients according to their specific needs. Prior to the interview, participants will also be asked to complete a short questionnaire that collects basic demographic information.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. MCI Diagnosis: Individuals with mild cognitive impairment (MCI) are eligible to participate, without a formal dementia diagnosis.
2. MCI Type: Both amnestic and non-amnestic MCI individuals qualify for participation.
3. Adult Child: Must have an adult child willing to participate in the program, free from serious health issues, both physically and cognitively.

Exclusion criteria:

1. Dementia Diagnosis: Individuals formally diagnosed with dementia cannot participate.
2. MCI from Specific Causes: Excludes those with MCI caused by frontotemporal dementia or Parkinson's.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interview; Conducting interviews with MCI patients to identify their needs and preferences related to the intervention to be developed	Other: No intervention, interviews with MCI patients as part of the development phase; No intervention, interviews with MCI patients as part of the development phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needs Assessment in MCI Patients and Their Children based on Think Aloud Interviews	The interviews utilized a guide with "needs assessment cards" based on literature findings, addressing difficulties, motivators, and specific needs of MCI patients and their children. Participants were encouraged to use cards for relevance but had the freedom to express additional difficulties or motivators. Instructions provided clarity at the beginning of the card bundle. Collected data will be aggregated by categorizing responses from 'needs assessment cards' into themes, providing insights into common challenges, motivators, and specific needs. This streamlined analysis aids in identifying patterns and tailoring interventions for MCI patients and their children.	2 hours

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent
• Investigators: Principal Investigator: Tim Vanlangenhove, Dr., University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: MCI-project - ONZ-2023-0246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No