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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04658160
Other study ID # 59260
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2024
Est. completion date May 2025

Study information

Verified date November 2023
Source Stanford University
Contact Maya Chatterjee, MSc
Phone 4157282191
Email mchatter@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates whether a health tracking platform improves an elderly person's health with regards to frailty over the course of a year. Secondary research questions examine which instruments are the best predictors of frailty to improve preventative measures in the future.


Description:

All patients presenting to the Annual Wellness Visit at Stanford Hospital will be considered for this study. Eligible who consent will be asked to conduct several activities, which will be video taped and timed. The activities include: - Timed up and go: patients will be asked to rise from a chair and walk 10 feet (3 m), turn, walk back to the chair, and sit down. - QuickDASH tasks: open a jar, carry a shopping bag, cut food with a knife, wash back, wash a wall, and hammer a piece of wood. - KOOS JR tasks: go up/down stairs, stand upright - PROMIS PF tasks: lift heavy object repeat x5, shoelace or buttons, wash hair Patients will then be asked to complete a survey consisting of a number of validated questionnaires used to collect patient reported outcome measures and assess frailty. Patients will be randomly assigned to one of two conditions, the control condition or the frailty wellness platform condition. Patients assigned to the frailty wellness platform condition will be given an orientation to a health tracking program. They will be asked to fill out the questionnaires at 3 separate time points on the program site (accessed via phone or computer) at 3 months, 6 months, and 9 months, following orientation. One year later, at the patient's second Annual Wellness Visit, the patient will be asked to fill out the Health Risk Assessment and the study will conclude.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - geriatric patients >65 years of age Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
access to/use of the tracking platform

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

References & Publications (2)

Liu LH, Garrett SB, Li J, Ragouzeos D, Berrean B, Dohan D, Katz PP, Barton JL, Yazdany J, Schmajuk G. Patient and clinician perspectives on a patient-facing dashboard that visualizes patient reported outcomes in rheumatoid arthritis. Health Expect. 2020 Aug;23(4):846-859. doi: 10.1111/hex.13057. Epub 2020 Apr 9. — View Citation

Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Health Risk Assessment A multi-component health survey representing the participant's assessment of their health status Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)
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