Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06038643
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2022-04-25
Brief Title:
Intergenerational Behavioral Intervention to Enhance Physical Activity in Older Adults at Risk for Alzheimers Disease
Sponsor:
Douglas Mental Health University Institute
Organization:
Douglas Mental Health University Institute
Study Overview
Official Title:
The Healthy Aging Brain Study A Remote Behavioral Intervention to Enhance Physical Activity in Older Adults
Status:
COMPLETED
Status Verified Date:
2024-10
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:
HABS
Brief Summary:
This is a four-week pilot randomized controlled trial of a behavioral intervention in older adults at risk for Alzheimers disease Older participants are a subgroup from the PREVENT-AD longitudinal cohort We will test whether a four-week intergenerational social motivation using a technology-based platform intervention group enhances physical activity relative to a control group
Detailed Description:
This study is a two-arm single-site randomized controlled trial to test whether a four-week technology-based intergenerational social motivation intervention enhances physical activity in 60 cognitively unimpaired older adults with a first-degree history of Alzheimers disease These at-risk older adults will be recruited as a subgroup from a longitudinal cohort at McGill University PREVENT-AD At the outset half of the participants will be randomized to the intergenerational social motivation condition intervention group and the other half will be randomized to the control group 11 A multimodal AD risk score based on older participants already acquired AD biomarker health and cognitive data will be used as strata for randomization to ensure equal assignment of high-risk participants to Intervention and control groups using a permuted block method with random blocks
The primary outcome is an increase in step count as measured by accelerometer Secondary outcomes are an increase in total physical activity mood generativity cognition and loneliness After an initial visit consisting of behavioral testing and structural and functional MRI participants in the intervention group will be paired with younger adults 14 to 40 years to form intergenerational dyads Younger adults are either a family member of the older adult or a younger adult recruited from the community Participants in the intervention group will receive personalized positive daily messages over a four-week period via their device using the Our Family Garden technology platform These daily messages combine 1 pro-social goals donation to charity after reaching exercise goals 2 intergenerational social engagement and 3 positive personalized messages from their younger study partners This study will have 6 visits over a 2-month period in addition to the four-week intervention period 3 months total Cognitive and behavioral data will be collected at each visit and physical activity data will be collected over the intervention period
The primary endpoint is defined as the end of the initial period Data collected are stored in one of three ways 1 Physical activity monitoring data are extracted from their respective software packages and uploaded directly to a secure data storage environment at a high-performance computing facility All pen-and-paper psychosocial and neuropsychological assessments are scored and entered in REDCap Computerized psychosocial assessments are collected directly in REDCap and computerized neuropsychological assessments are entered in REDCap TextMagic is used to distribute the daily intervention messages Collected and anonymized survey data are stored on the web application behind an administrative login developed with Django a high-level Python web framework All data from REDCap will be exported to CSV files using the data de-identification feature for subsequent analysis with R and SPSS statistical analysis packages After compiling all data across the 3 different data servers data will be checked for completeness and correctness using frequency distributions for missing data and out-of-range values For the final dataset the multiple imputations by chained equations MICE will be used to input missing values with 10 imputations
The primary outcome is an increase in step count as measured by accelerometer Secondary outcomes are an increase in total physical activity mood generativity cognition and loneliness After an initial visit consisting of behavioral testing and structural and functional MRI participants in the intervention group will be paired with younger adults 14 to 40 years to form intergenerational dyads Younger adults are either a family member of the older adult or a younger adult recruited from the community Participants in the intervention group will receive personalized positive daily messages over a four-week period via their device using the Our Family Garden technology platform These daily messages combine 1 pro-social goals donation to charity after reaching exercise goals 2 intergenerational social engagement and 3 positive personalized messages from their younger study partners This study will have 6 visits over a 2-month period in addition to the four-week intervention period 3 months total Cognitive and behavioral data will be collected at each visit and physical activity data will be collected over the intervention period
The primary endpoint is defined as the end of the initial period Data collected are stored in one of three ways 1 Physical activity monitoring data are extracted from their respective software packages and uploaded directly to a secure data storage environment at a high-performance computing facility All pen-and-paper psychosocial and neuropsychological assessments are scored and entered in REDCap Computerized psychosocial assessments are collected directly in REDCap and computerized neuropsychological assessments are entered in REDCap TextMagic is used to distribute the daily intervention messages Collected and anonymized survey data are stored on the web application behind an administrative login developed with Django a high-level Python web framework All data from REDCap will be exported to CSV files using the data de-identification feature for subsequent analysis with R and SPSS statistical analysis packages After compiling all data across the 3 different data servers data will be checked for completeness and correctness using frequency distributions for missing data and out-of-range values For the final dataset the multiple imputations by chained equations MICE will be used to input missing values with 10 imputations
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 |
|---|---|---|---|
| P30AG048785 | NIH | None | httpsreporternihgovquickSearchP30AG048785 |