Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
Primary Purpose
Frailty
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
Sponsored by
About this trial
This is an interventional health services research trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- geriatric patients >65 years of age
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention/Tracking
Arm Description
None- normal care
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)
Outcomes
Primary Outcome Measures
Health Risk Assessment
A multi-component health survey representing the participant's assessment of their health status
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04658160
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
None- normal care
Arm Title
Intervention/Tracking
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
Intervention Description
access to/use of the tracking platform
Primary Outcome Measure Information:
Title
Health Risk Assessment
Description
A multi-component health survey representing the participant's assessment of their health status
Time Frame
Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
geriatric patients >65 years of age
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Chatterjee, MSc
Phone
4157282191
Email
mchatter@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Kamal, MD MBA
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22836700
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.
Results Reference
background
PubMed Identifier
32270591
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.
Results Reference
background
Learn more about this trial
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
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