A Randomized Control Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes

CompletedNot a drug-phase studyMS (type not specified)NCT05442112

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Wellness Patient Message

What it measured

Main measures

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

    Baseline, 1 month, 3 months

Other measures (4)

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

    Baseline, 1 month, 3 months

    Mood and sleepQuality of life (reported by participants)
  • Change in Diet behavior Scores as assessed by the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score)

    Baseline, 1 month, 3 months

    Quality of life (reported by participants)
  • Change in Reported physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Baseline, 1 month, 3 month

    Physical functionQuality of life (reported by participants)
  • Change in Reported physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) short form

    Baseline, 1 month, 3 month

    Physical functionQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 89

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2023

    2. Main results due

      May 2024

    3. Finished

      May 2024

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