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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
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 1, 2020
    Last Updated
    August 4, 2022
    Sponsor
    Stanford University
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    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
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    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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