Mild Cognitive ImpairmentMCI-projectNCT06221579
An Intergenerational, Cognitively Enriched Intervention for MCI Patients and Their Children.
A study of Mild Cognitive Impairment, run by University Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Sep 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia Diagnosis: Individuals formally diagnosed with dementia cannot participate.
- MCI from Specific Causes: Excludes those with MCI caused by frontotemporal dementia or Parkinson's.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- No intervention, interviews with MCI patients as part of the development phase
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, interviews with MCI patients as part of the development phaseOther
No intervention, interviews with MCI patients as part of the development phase
| Study group | Role | What they receive |
|---|---|---|
| Interview | Experimental | Conducting interviews with MCI patients to identify their needs and preferences related to the intervention to be developed Receives: Other: No intervention, interviews with MCI patients as part of the development phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start13 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interviews with MCI patients to develop the intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Tim Vanlangenhove, Dr., Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221579
- Sponsor's protocol ID
- MCI-project - ONZ-2023-0246
- Acronym
- MCI-project
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intergenerational, Cognitively Enriched Lifestyle Intervention for Patients With a Mild Cognitive Impairment (MCI) and Their Children.
- ClinicalTrials.gov ID
- NCT06221579
- Acronym / sponsor ID
- MCI-project / MCI-project - ONZ-2023-0246
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interviews with MCI patients to develop the intervention.
| Arm | Type | Receives |
|---|---|---|
| Interview | Experimental | Other: No intervention, interviews with MCI patients as part of the development phaseConducting interviews with MCI patients to identify their needs and preferences related to the intervention to be developed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Dementia Diagnosis: Individuals formally diagnosed with dementia cannot participate.
- MCI from Specific Causes: Excludes those with MCI caused by frontotemporal dementia or Parkinson's.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, interviews with MCI patients as part of the development phaseNo intervention, interviews with MCI patients as part of the development phase | Other | Interview |
Primary outcome
Needs Assessment in MCI Patients and Their Children based on Think Aloud Interviews
Time frame: 2 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Vanlangenhove, Dr. principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mild Cognitive Impairment, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs Assessment in MCI Patients and Their Children based on Think Aloud Interviews (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.