- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06094374
Unveiling the Digital Phenotype of PA Behavior (MIADP)
Unveiling the Digital Phenotype: A Protocol for a Prospective Study on Physical Activity Behavior in Community-dwelling Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Observational data will be collected in healthy older adults aged 65 or above combining both cross-sectional and longitudinal data collection methods to analyze patterns of PA behavior and identify prognostic factors affecting PA outcomes in order to identify digital phenotypes related to PA.
The measurements are based on the Behavioral Change Wheel and include self-reporting assessments, clinical assessments for cross-sectional data collection and ecological momentary assessment (EMA) as well as time series data collection for longitudinal data. The statistical analysis will involve multivariate regression analysis and time series analysis, with a Bonferroni correction to account for multiple comparisons. A machine learning algorithm is used due to the complexity of the data. If no suitable model is found, a neural network will be used to determine digital phenotypes related to PA behavior in older adults.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kim Daniels, MS
- Phone Number: 0032485763451
- Email: kim.daniels@pxl.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants are 65 years of older
- Participants are competent to give informed consent
- Participants are able to actively participate in the study
- Participants are community-dwelling (living independent at home or in a service apartment)
- Without a severe illness
- Dutch language proficiency as native speaker
Exclusion Criteria:
- Current neurological disorder such as Parkinson's disease, multiple sclerosis, cerebrovascular accident, …
- Current cardiovascular disorder such as stroke, acute myocardial infarct, coronary artery bypass grafting, percutaneous coronary intervention less than 5 years ago
- Current respiratory disorder, such as chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, asthma, …
- Current severe metabolic disorder, such as diabetes type 1 and 2, severe osteoporosis, …
- Current severe cognitive disorders, such as Alzheimer's disease, vascular dementia, Lewy Body dementia, frontotemporal dementia,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Community Dwellling Healthy Older Adults
|
An observational study will be conducted to gather data on multiple levels aiming to identify diverse digital phenotypes related to PA behavior among community-dwelling older adults. A hybrid approach will be employed, combining both cross-sectional and longitudinal data collection methods. The overall aim is to employ data analysis to identify patterns of PA - behavior (referred to as phenotypes) and to pinpoint prognostic factors that affect PA outcomes. This integrated strategy will be complemented by four distinct measurement approaches, ensuring a comprehensive assessment of the research objectives. These measurement approaches include:self-reporting, clinical, ecological momentary and time series assessment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digital phenotypes of PA
Time Frame: 14 days
|
Patterns of physical activity behavior
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kim Daniels, MS, PXL University College of Applied Sciences and Arts
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MIADP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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