Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes

Summary

In this project, the investigators hope to evaluate effective methods of communication with patients with multiple sclerosis regarding habits of physical activity, sleep, and diet. Currently, there is weak evidence regarding how to deliver adequate information at scale in the clinics with respect to diet, exercise, and sleep. It is unclear if receiving structured information impacts patient-reported outcomes in multiple sclerosis (MS).

The study team hopes to evaluate the efficacy of after visit direct patient messaging in promoting any behavioral changes, the sustainability of those behavioral changes, and most importantly, if those changes impact patient-reported sense of self-efficacy in the participants disease management. In addition, the study team hopes that the data collected during this study will provide answers on how providing wellness strategies impacts patient reported outcomes, markers of behavior, and sense of disease progression.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

Wellness Patient Message

The intervention is a detailed patient message containing information on strategies for exercise in MS, how to maintain proper sleep, and dietary improvements to maximize health. These strategies are derived from information provided by the National MS Society in their website and covers these topics in greater detail than would normally be addressed in a normal clinic visit. The message also directs patients to the National MS Society website if they would like more information.

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Shuvro Roy, MD · Johns Hopkins University

• Ellen Mowry, MD · Johns Hopkins University

• Scott Newsome, MD · Johns Hopkins University

• Peter Calabresi, MD · Johns Hopkins University

• Shiv Saidha, MBBCh · Johns Hopkins University

• Pavan Bhargava, MD · Johns Hopkins University

• Michael Kornberg, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-11

Primary Completion

2024-05-11

Completion

2024-05-11

Countries

• United States

Study Locations