Clinical trial NCT04658160: Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
Official title: Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients: A Prospective RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* geriatric patients \>65 years of age

Exclusion Criteria:

* none

Primary outcomes:
measure: Health Risk Assessment
timeFrame: Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Robin Kamal, MD MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.