Sallie Life U Feasibility Study | NCT06812897

Studies
Sallie Life U Feasibility Study

NCT06812897

Sponsor

Life University

Status

Active, not recruiting

Last Update Posted

Feb 12, 2025Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Healthy

Interventions

Sallie (TM) Life U

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Jan 30, 2025Actual

Completion Date

May 2025Estimated

First Submitted Date

Jan 31, 2025

First Submission Date that Met QC Criteria

Jan 31, 2025

First Posted Date

Feb 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2025

Last Update Posted Date

Feb 12, 2025Actual

Name	Class
Power of Patients	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This feasibility trial explored the usability of the patient-driven chiropractic patient portal, Sallie™ Life U. The study aimed to recruit 30 participants to track their daily symptoms, triggers, and habits over 30 days while completing three questionnaires about their experience with the portal. The first questionnaire was administered after participants created their accounts, the second at the midpoint of tracking (day 15), and the third upon completing the tracking period (day 30). All participation in the study was conducted remotely using the participants' personal devices.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Healthy subjects	Other: Sallie (TM) Life U

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sallie (TM) Life U	Other	Testing of Sallie (TM) Life U platform	Healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Recruitment	Average # of participants to create a SallieTM Life U account per month	30 days
Participant Adherence - Weekly	% of participants with daily data input throughout the week	30 days
Participant Adherence - Monthly	% of participants with total number of daily data input throughout the month.	30 days
Participant Retention	% of participants completing all questionnaires	30 days

Secondary Outcomes

Measure	Description	Time Frame
Personalized Tracking Metrics (PTMs)	Self-generated habits or personal goals that participants create and track in their portals	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have daily access to technology (smartphone, tablet, or computer)
Currently receiving chiropractic care (for the purposes of this feasibility study, this requires at least one chiropractic adjustment each month)

Exclusion Criteria:

- Given software restrictions, participants must also be able to read and write in English and not be visually impaired.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

No specific population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephanie Sullivan, DC, PhD	Dr. Sid E Williams Center for Chiropractic Research	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Sid E Williams Center for Chiropractic Research		Marietta	Georgia	30060	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided