Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes

NCT05442112 | Completed

• 1 other identifier: IRB00310601
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in self-efficacy as assessed by the MS Self-Efficacy Scale (MSSE)

  Patients will take the MS Self-Efficacy Scale (MSSE), which has a score range 90-900, with higher scores reflecting greater sense of self-efficacy

  Baseline, 1 month, 3 months

Secondary Outcomes (4)

• Change in Sleep Disturbance the Neuro-Quality of Life Sleep disturbance short form

  Baseline, 1 month, 3 months

• Change in Diet behavior Scores as assessed by the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score)

  Baseline, 1 month, 3 months

• Change in Reported physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

  Baseline, 1 month, 3 month

• Change in Reported physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) short form

  Baseline, 1 month, 3 month

Study Arms (2)

Wellness Smartphrase

EXPERIMENTAL

This arm will receive a secure message after the conclusion of their standard clinic visit providing a set script containing information on a number of wellness-related topics in MS (sleep, diet, exercise).

Behavioral: Wellness Patient Message

No Intervention

NO INTERVENTION

This arm will not receive a secure message after their appointment, and will instead receive their standard care with their provider.

Interventions

Wellness Patient Message BEHAVIORAL

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.

Wellness Smartphrase

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-89 years of age
• Diagnosis of MS (G35) seen at the Johns Hopkins MS Precision Medicine Center of Excellence within the past year, and upcoming appointment within the three-month window. We will require the relevant ICD10 code to be documented at least twice in two separate visits, either in the problem list and/or visit diagnosis, in order to avoid misdiagnosis.
• MyChart active account
• Provides consent to complete questionnaires and undergo randomization

You may not qualify if:

• Patients known to be deceased in Epic
• Patients who have opted out of being contacted for research recruitment
• Patients who have opted out of being contacted for MyChart recruitment
• Patients who have opted out of being contacted for any reason

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Motl RW, Mowry EM, Ehde DM, LaRocca NG, Smith KE, Costello K, Shinto L, Ng AV, Sullivan AB, Giesser B, McCully KK, Fernhall B, Bishop M, Plow M, Casaccia P, Chiaravalloti ND. Wellness and multiple sclerosis: The National MS Society establishes a Wellness Research Working Group and research priorities. Mult Scler. 2018 Mar;24(3):262-267. doi: 10.1177/1352458516687404. Epub 2017 Jan 12.

  PMID: 28080254 BACKGROUND

• Motl RW, McAuley E, Snook EM, Gliottoni RC. Physical activity and quality of life in multiple sclerosis: intermediary roles of disability, fatigue, mood, pain, self-efficacy and social support. Psychol Health Med. 2009 Jan;14(1):111-24. doi: 10.1080/13548500802241902.

  PMID: 19085318 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shuvro Roy, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Ellen Mowry, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Scott Newsome, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Peter Calabresi, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Shiv Saidha, MBBCh

  Johns Hopkins University

  STUDY DIRECTOR

• Pavan Bhargava, MD

  Johns Hopkins University

  STUDY DIRECTOR

• Michael Kornberg, MD

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will not know which arm they are assigned to, and neither will their provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 within provider schedules to either receive a secure message containing a set script on wellness-related topics in MS, or no additional information other than that provided by their clinician.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 11, 2023
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)