MIADP: Unveiling the Digital Phenotype of PA Behavior

Sponsor
PXL University College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06094374
Collaborator
Hasselt University (Other)
200
12

Study Details

Study Description

Brief Summary

Observational data from healthy adults aged 65+ will be collected through cross-sectional and longitudinal methods to analyze physical activity patterns, identifying digital phenotypes. Measurements include self-reports, clinical assessments, and EMA, with statistical analysis using multivariate regression and time series analysis, and a neural network if needed to find digital phenotypes related to physical activity in older adults.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: observation of physical activity behavior

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Unveiling the Digital Phenotype: A Protocol for a Prospective Study on Physical Activity Behavior in Community-dwelling Older Adults
Anticipated Study Start Date :
Jan 15, 2024
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Community Dwellling Healthy Older Adults

65 years or older able to give informed consent community dwelling no severe illness (neurological, cardiovascular, respiratory, metabolic, cognitive disorder) dutch language profiency

Behavioral: observation of physical activity behavior
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.

Outcome Measures

Primary Outcome Measures

  1. Digital phenotypes of PA [14 days]

    Patterns of physical activity behavior

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PXL University College
  • Hasselt University

Investigators

  • Principal Investigator: Kim Daniels, MS, PXL University College of Applied Sciences and Arts

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PXL University College
ClinicalTrials.gov Identifier:
NCT06094374
Other Study ID Numbers:
  • MIADP
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 23, 2023