Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes

Johns Hopkins University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Wellness Patient Message

Study type: Interventional

Funder types: Other

Identifiers

NCT05442112

IRB00310601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Wellness Smartphrase

Experimental group

Description:

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).

Treatment:

Behavioral: Wellness Patient Message

No Intervention

No Intervention group

Description:

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