FrailtyNCT04658160
Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
A study testing Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients in people with Frailty, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- geriatric patients >65 years of age
Who cannot join
- none
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients: A Prospective RCT
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Tracking and Intervention Platform for Medicare Advantage PatientsBehavioural
access to/use of the tracking platform
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | None- normal care |
| Intervention/Tracking | Experimental | 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) Receives: Behavioral: Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Risk Assessment
A multi-component health survey representing the participant's assessment of their health status
Measured: Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
- Investigators
- Robin Kamal, MD MBA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658160
- Sponsor's protocol ID
- 59260
- Status last verified
- Feb 2026
- First submitted
- 1 Dec 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22836700Liu 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.
PubMed 32270591
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients: A Prospective RCT
- ClinicalTrials.gov ID
- NCT04658160
- Acronym / sponsor ID
- 59260
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –None- normal care |
| Intervention/Tracking | Experimental | Behavioral: Longitudinal Tracking and Intervention Platform for Medicare Advantage PatientsThis 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) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- geriatric patients >65 years of age
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Longitudinal Tracking and Intervention Platform for Medicare Advantage Patientsaccess to/use of the tracking platform | Behavioural | Intervention/Tracking |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 22836700Morley 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.
- Background: PubMed 32270591Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Kamal, MD MBA principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients in people with Frailty, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Chatterjee, MSc (4157282191, mchatter@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Risk Assessment (time frame: Change in participant's Health Risk Assessment from beginning of study to end (1 year duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04658160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.