Multiple SclerosisCONNECTNCT04943887
CONNECT Trial of eSupport Online Health-coach Moderated Support Groups for Multiple Sclerosis
A study testing eSupport Health Weekly Group Sessions for PwMS in people with Multiple Sclerosis, run by eSupport Health at 1 site in United States.
Trial summary
Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- eSupport Health Weekly Group Sessions for PwMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 1 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form (ICF)
- Able to speak, read and understand English
- Reside in the U.S.
- Willingness to enroll as a member in eSupport Health
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Willingness to adhere to the schedule of weekly online meetings with a minimum of 50% attendance (i.e., 6 of 12 meetings)
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- Males and females; Age 18+
- Self-reported diagnosis of multiple sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician
- Access to necessary resources for participating in a technology-based intervention (i.e., computer or tablet with a web camera and with a stable internet connection in a private setting) and demonstrated basic ability to use a computer by completing the electronic ICF completion process and meeting with the Study Coach via Zoom Telehealth secured platform at the Enrollment Session.
- Provide identification to verify name, date of birth, and address.
Who cannot join
- Current participation in another treatment or intervention study
- Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
- Current suicidal intent
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)
Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients).
Read the detailed description
The purpose of this research is to see how well a new online eSupport Health Weekly Group Sessions program addresses the needs and improves the mood of adults with MS. This study is focusing on improving the online eSupport Weekly Group Session program for people with MS while assessing the impact of the program, particularly for Black and Latinx individuals as clinical research has often not included their experience.
The entire study is done remotely by computer, tablet, or smartphone with a web camera and with a stable internet connection. Subjects will be enrolled into closed, private, health-coach facilitated online support groups called eSupport Health Weekly Group Sessions. These sessions are hosted on eSupport Health's proprietary Zoom-based secure HIPAA-compliant telehealth platform. Each group is expected to have 10 participants and will meet weekly for 12 weeks. A licensed therapist ("Study Coach") leads the group sessions. The company's Mutual Respect \& Trust (MRT)-based coaching method is utilized.
- Conditions
- Multiple Sclerosis
- Being tested
- eSupport Health Weekly Group Sessions for PwMS
- Keywords
- Online Support Group
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSupport Health Weekly Group Sessions for PwMSBehavioural
A formal semi-structured program of psychoeducational support delivered in an online weekly small group format by health coaches (licensed therapists) who specialize in MS.
| Study group | Role | What they receive |
|---|---|---|
| PwMS eSupport Groups | Experimental | 12-weeks active treatment of eSupport Health's Weekly Group Sessions, a formal semi-structured program of psychoeducational support delivered in a small group format by licensed therapists who specialize in MS. The active treatment period will follow a 12-week waitlist period that will be used to enable a within-subject control design. Note that the very first group enrolled (N~10) will not have a 12-week waitlist period but will instead enter directly into the 12-week treatment. Receives: Behavioral: eSupport Health Weekly Group Sessions for PwMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence and completion
The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.
Measured: through study completion, 20-40 weeks
Secondary outcomes (1)
Hospital Anxiety and Depression Scale (HADS)
The primary efficacy outcome is to determine whether participation in 12-weeks of eSupport Health online groups results in decreased anxiety or depression.
Measured: through study completion, up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Aug 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will serve as his/her own control; after a 12-week waitlist control period, each participant will complete a 12-week treatment period \[note that the very first group of enrolled participants (N \~10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period\].
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- eSupport Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria M Leavitt, Leavitt, Principal investigator, eSupport Health, PBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943887
- Sponsor's protocol ID
- MSO01-P001
- Acronym
- CONNECT
- Status last verified
- Aug 2022
- First submitted
- 14 Jun 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of a Telehealth Group-Based Intervention to Improve Mood in Underrepresented Individuals With Multiple Sclerosis: The Connect Trial (CONNECT)
- ClinicalTrials.gov ID
- NCT04943887
- Acronym / sponsor ID
- CONNECT / MSO01-P001
- Conditions
- Multiple Sclerosis
- Keywords
- Online Support Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- eSupport HealthUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 Jun 2021 (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.
Within-subject waitlist-control group design trial of eSupport health-coach moderated online support group participation to address mental health needs in persons with multiple sclerosis (PwMS) from historically underrepresented groups (i.e., Black and Latinx patients).
Detailed description
The purpose of this research is to see how well a new online eSupport Health Weekly Group Sessions program addresses the needs and improves the mood of adults with MS. This study is focusing on improving the online eSupport Weekly Group Session program for people with MS while assessing the impact of the program, particularly for Black and Latinx individuals as clinical research has often not included their experience.
The entire study is done remotely by computer, tablet, or smartphone with a web camera and with a stable internet connection. Subjects will be enrolled into closed, private, health-coach facilitated online support groups called eSupport Health Weekly Group Sessions. These sessions are hosted on eSupport Health's proprietary Zoom-based secure HIPAA-compliant telehealth platform. Each group is expected to have 10 participants and will meet weekly for 12 weeks. A licensed therapist ("Study Coach") leads the group sessions. The company's Mutual Respect \& Trust (MRT)-based coaching method is utilized.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will serve as his/her own control; after a 12-week waitlist control period, each participant will complete a 12-week treatment period [note that the very first group of enrolled participants (N ~10) will not have a waitlist period, but will instead enter directly into the 12-week treatment period].
| Arm | Type | Receives |
|---|---|---|
| PwMS eSupport Groups | Experimental | Behavioral: eSupport Health Weekly Group Sessions for PwMS12-weeks active treatment of eSupport Health's Weekly Group Sessions, a formal semi-structured program of psychoeducational support delivered in a small group format by licensed therapists who specialize in MS. The active treatment period will follow a 12-week waitlist period that will be used to enable a within-subject control design. Note that the very first group enrolled (N~10) will not have a 12-week waitlist period but will instead enter directly into the 12-week treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated informed consent form (ICF)
- Able to speak, read and understand English
- Reside in the U.S.
- Willingness to enroll as a member in eSupport Health
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (4 listed)
- Current participation in another treatment or intervention study
- Presence of a condition(s) or diagnosis, either physical or psychological that precludes participation such as significant brain injury and developmental disability
- Current suicidal intent
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
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 |
|---|---|---|
| eSupport Health Weekly Group Sessions for PwMSA formal semi-structured program of psychoeducational support delivered in an online weekly small group format by health coaches (licensed therapists) who specialize in MS. | Behavioural | PwMS eSupport Groups |
Primary outcome
Adherence and completion
Time frame: through study completion, 20-40 weeks
The primary objective is to establish feasibility, defined as acceptable rates of <1> adherence, and <2> completion.
1 secondary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: through study completion, up to 40 weeks
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 23 Aug 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Victoria M Leavitt, Leavitt principal investigator
eSupport Health, PBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSupport Health Weekly Group Sessions for PwMS in people with Multiple Sclerosis, run by eSupport Health 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 10 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 23 Aug 2022. 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?
Adherence and completion (time frame: through study completion, 20-40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2022.