跳至主要内容
临床试验/NCT05442112
NCT05442112已完成不适用

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

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Change in self-efficacy as assessed by the MS Self-Efficacy Scale (MSSE)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Participants will not know which arm they are assigned to, and neither will their provider.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Baseline, 1 month, 3 months

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

次要结局

  • 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 Sleep Disturbance the Neuro-Quality of Life Sleep disturbance short form(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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Trial of eHealth Wellness Behavioral Interventions... | 临床试验