Next-Gen MS: Feed-forward PRO Data for MS Research

Next-Gen MS: A Prospective, Cluster-randomized Study Evaluating the Impact of Feed-forward Patient Reported Outcomes Data to Clinical Teams Managing Adults Living With MS in a Learning Health System for MS Research

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04907305

Enrollment

1594

Registered

2021-05-28

Start date

2021-11-02

Completion date

2024-02-19

Last updated

2024-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis (MS)

Keywords

Multiple Sclerosis, Patient Reported Outcomes, Patient Determined Disease Steps, Learning Healthcare System

Brief summary

This Next Generation learning health system for Multiple Sclerosis (Next-Gen MS) study is a sub-study of the MS-LINK™ Outcomes Study (NCT04735406). The study aims to examine the effects of using feed forward Patient Reported Outcomes (PROs) data in real-world Multiple Sclerosis (MS) care settings. The study will be conducted within an emerging Learning Healthcare System (LHS).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants willing and able to provide written informed consent * Participants with clinical diagnosis of Multiple Sclerosis (MS)

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Health-Related Quality of Life 14 Item (HR-QoL-14)	Baseline up to 18 Months

Secondary

Measure	Time frame
Percentage of Participants with >=1-point Increase from Baseline in Patient Determined Disease Steps (PDDS) Sustained Via Consecutive Measures Over 3 Months	Baseline up to 18 Months

Countries

United States

Outcome results