- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04658160
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients: A Prospective RCT
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maya Chatterjee, MSc
- Phone Number: 4157282191
- Email: mchatter@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- geriatric patients >65 years of age
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
None- normal care
|
|
Experimental: Intervention/Tracking
This group will have access to the longitudinal tracking and intervention platform for Medicare Advantage patients.
Members of this group's care team will have access to the longitudinal data on the platform and will be able to intervene if any red flags emerge (i.e. if a patient displays signs of depression on a patient reported outcome measure/survey)
|
access to/use of the tracking platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Risk Assessment
Time Frame: Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robin Kamal, MD MBA, Stanford University
Publications and helpful links
General Publications
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59260
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 drug product
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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