An Intergenerational, Cognitively Enriched Intervention for MCI Patients and Their Children.

NCT06221579 | Enrolling By Invitation DMC

• 1 other identifier: MCI-project - ONZ-2023-0246
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Interview

EXPERIMENTAL

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

Interventions

No intervention, interviews with MCI patients as part of the development phase OTHER

No intervention, interviews with MCI patients as part of the development phase

Interview

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• University Hospital, Ghent: collaborator

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tim Vanlangenhove, Dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interviews with MCI patients to develop the intervention.

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 24, 2024
• Study Start: September 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)