Multiple SclerosisNCT05442112
Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes
A study testing Wellness Patient Message in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Wellness Patient Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2023to 11 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
About this study
Official title: A Randomized Control Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes
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.
Read the 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
- Being tested
- Wellness Patient Message
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Patient MessageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 1 month, 3 months
Secondary outcomes (4)
Change in Sleep Disturbance the Neuro-Quality of Life Sleep disturbance short form
Patient-reported outcomes on the Neuro-Quality of Life Sleep disturbance short form, which has a score range of 8-40, with higher scores reflecting better quality of sleep.
Measured: Baseline, 1 month, 3 months
Change in Diet behavior Scores as assessed by the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score)
Patient-reported behaviors on diet through the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score), which has a score range of 0-15, with higher scores reflecting a higher, healthier, quality of diet.
Measured: Baseline, 1 month, 3 months
Change in Reported physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Patient-reported behaviors on physical activity through the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The score range is from 0-119, with higher scores reflecting a greater degree of physical exercise.
Measured: Baseline, 1 month, 3 month
Change in Reported physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) short form
Patient-reported behaviors on physical activity through the International Physical Activity Questionnaire (IPAQ) short form. Results are reported in metabolic minutes (MET-min), and are continuous, with range of 0-200,000 per week, and higher scores indicating greater physical activity.
Measured: Baseline, 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start11 Jun 2023
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuvro Roy, MD, Study director, Johns Hopkins UniversityEllen Mowry, MD, Principal investigator, Johns Hopkins UniversityScott Newsome, MD, Study director, Johns Hopkins UniversityPeter Calabresi, MD, Study director, Johns Hopkins UniversityShiv Saidha, MBBCh, Study director, Johns Hopkins UniversityPavan Bhargava, MD, Study director, Johns Hopkins UniversityMichael Kornberg, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442112
- Sponsor's protocol ID
- IRB00310601
- Status last verified
- May 2024
- First submitted
- 28 Jun 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Publications
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.
PubMed 28080254Motl 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.
PubMed 19085318
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of eHealth Wellness Behavioral Interventions and Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT05442112
- Acronym / sponsor ID
- IRB00310601
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Wellness Smartphrase | Experimental | Behavioral: Wellness Patient MessageThis 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). |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Patient MessageThe 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. | Behavioural | Wellness Smartphrase |
Primary outcome
Change in self-efficacy as assessed by the MS Self-Efficacy Scale (MSSE)
Time frame: 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
4 secondary outcomes
Change in Sleep Disturbance the Neuro-Quality of Life Sleep disturbance short form
Time frame: Baseline, 1 month, 3 months
Change in Diet behavior Scores as assessed by the Mediterranean-DASH Intervention for Neurodegenerative Delay score (MIND Diet score)
Time frame: Baseline, 1 month, 3 months
Change in Reported physical activity as assessed by the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline, 1 month, 3 month
Change in Reported physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) short form
Time frame: Baseline, 1 month, 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 28080254Motl 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.
- Background: PubMed 19085318Motl 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuvro Roy, MD study director
Johns Hopkins University
Ellen Mowry, MD principal investigator
Johns Hopkins University
Scott Newsome, MD study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Patient Message in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-efficacy as assessed by the MS Self-Efficacy Scale (MSSE) (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442112, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.