Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients

Frailty Clinical Trial

Official title:

Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients: A Prospective RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658160
• Other study ID #: 59260
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Frailty

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)