Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes

NCT ID: NCT05442112

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-11
• Study Completion Date: 2024-05-11

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.

Detailed Description

This will be a prospective randomized control trial assessing the impact of the delivery of wellness-related information on patient-reported outcomes in multiple sclerosis. The investigators plan to query all patients who meet inclusion criteria over the course of at least three consecutive months who will be seen at the Johns Hopkins Outpatient Center Multiple Sclerosis clinic. On average, 200 patients are seen in the MS clinic monthly, and the investigators hope to enroll 120 patients in this time period. If the investigators are unable to reach this target number in two months, the investigators will continue to message patients over consecutive months until the investigators reach this number. The study team will send a recruitment message through MyChart to all eligible patients prior to the patients next clinic appointment to participate in the study, after which the patients will be consented (with documentation of waiver of consent) if interested. Those who are interested will be asked to fill out a series of electronic baseline questionnaires prior to the patient's appointment (sent by REDCap using subject-specific links).

Participants will subsequently be randomized 1:1 (stratified within each provider's daily clinic schedule) to either receive a secure message providing a set script (see Supplementary Materials) containing information on a number of wellness-related topics in MS (sleep, diet, exercise), or to receiving no additional information other than that provided by the participants clinician. This message will be sent as a secure message through Epic by a member of the study team by the end of the clinic day.

At one month and three months after the clinic visit, the study team will send the same questionnaires as were sent at baseline, assessing self-efficacy, reported physical activity, dietary habits, and sleep quality through REDCap subject-specific links.

The investigators will assess for any differences in outcomes between the control group and the group who received the wellness-related secure message. The investigators will evaluate for covariates that were imbalanced and adjust models when imbalance did occur, which is plausible given the expected sample size. In addition, the investigators will also evaluate via chart review whether diet, exercise, and sleep were assessed or discussed during the clinic visit.

In addition, the investigators will use descriptive statistics to describe participants and compare those who agree versus those who do not agree to participate. The investigators hope to evaluate density of use of the electronic medical record amongst this cohort, as well as demographic data on social determinants of health, including race, socioeconomic status, and geographic location, in order to evaluate predictors of responsiveness to the messaging.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Wellness Smartphrase

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).

Group Type: EXPERIMENTAL

Wellness Patient Message

Intervention Type: 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.

No Intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shuvro Roy, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Ellen Mowry, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Scott Newsome, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Peter Calabresi, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Shiv Saidha, MBBCh

Role: STUDY_DIRECTOR

Johns Hopkins University

Pavan Bhargava, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Michael Kornberg, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28080254 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19085318 (View on PubMed)

Other Identifiers

IRB00310601

Identifier Type: -

Identifier Source: org_study_id