Multiple SclerosisNCT04662008
Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis
A study testing Tele-coaching and Website in people with Multiple Sclerosis and Caregivers, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Caregivers
- What is being tested?
- Tele-coaching and Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 7 Mar 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
- An adult family member or friend (18 years of age or older) of a person with MS
- Self-identified as an unpaid caregiver for person with MS
- Access to internet
- Capable of providing informed consent in English
Who cannot join
- Under age 18
- Cannot speak English
- Unable to provide consent
- No access to the internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44124
About this study
Official title: CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources
This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).
Read the detailed description
UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.
- Conditions
- Multiple Sclerosis, Caregivers
- Being tested
- Tele-coaching, Website
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-coachingBehavioural
This intervention arm will receive 4 one-to-one tele-coaching sessions facilitated by an advanced practice social worker. The sessions will take place over a 6-week period and will begin with a needs assessments to allow for tailoring of the intervention sessions. The sessions will include information and support in the areas of: general MS information, strategies for caring for a loved one with MS, MS and Covid (care strategies), caring for yourself, and planning for the future. The intervention will take place using Zoom videoconferencing technology or via telephone- per subject preference. In addition, all subjects will receive access to a study-specific website. The website will have links to publicly available information including general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.
WebsiteBehavioural
This intervention arm will receive access to a study-specific website. The website will have links to publicly available information including: general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.
| Study group | Role | What they receive |
|---|---|---|
| High resource tailored intervention | Active comparator | Tele-coaching arm Receives: Behavioral: Tele-coaching; Behavioral: Website |
| Low-resource web-only intervention | Active comparator | Website arm Receives: Behavioral: Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety, depression, and stress (DASS-42)
Change from baseline in anxiety, depression, and stress levels. Each of the three DASS scales contains 14 items. Using a 4-point Likert scale, scores range from 0- 42 for each scale. Higher scores indicate more depression, anxiety, and stress.
Measured: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks
Secondary outcomes (1)
COVID specific anxiety (CAS scale)
Change from baseline in COVID specific anxiety. Using a 5-point scale, from 0 (not at all) to 4 (nearly every day), total score ranges from 0-20 while individual items range from 0-4. Higher scores indicate higher anxiety.
Measured: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Mar 2021
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662008
- Sponsor's protocol ID
- MS-1610-37015 enhancement
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douglas SL, Plow M, Packer T, Lipson AR, Lehman MJ. Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Aug 26;10(8):e30617. doi: 10.2196/30617.
PubMed 34435971
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources
- ClinicalTrials.gov ID
- NCT04662008
- Acronym / sponsor ID
- MS-1610-37015 enhancement
- Conditions
- Multiple Sclerosis, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 10 Dec 2020 (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.
This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).
Detailed description
UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High resource tailored intervention | Active comparator | Behavioral: Tele-coaching, Behavioral: WebsiteTele-coaching arm |
| Low-resource web-only intervention | Active comparator | Behavioral: WebsiteWebsite arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- An adult family member or friend (18 years of age or older) of a person with MS
- Self-identified as an unpaid caregiver for person with MS
- Access to internet
- Capable of providing informed consent in English
Key exclusion criteria (4 listed)
- Under age 18
- Cannot speak English
- Unable to provide consent
- No access to the internet
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 |
|---|---|---|
| Tele-coachingThis intervention arm will receive 4 one-to-one tele-coaching sessions facilitated by an advanced practice social worker. The sessions will take place over a 6-week period and will begin with a needs assessments to allow for tailoring of the intervention sessions. The sessions will include information and support in the areas of: general MS information, strategies for caring for a loved one with MS, MS and Covid (care strategies), caring for yourself, and planning for the future. The intervention will take place using Zoom videoconferencing technology or via telephone- per subject preference. In addition, all subjects will receive access to a study-specific website. The website will have links to publicly available information including general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning. | Behavioural | High resource tailored intervention |
| WebsiteThis intervention arm will receive access to a study-specific website. The website will have links to publicly available information including: general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning. | Behavioural | High resource tailored intervention, Low-resource web-only intervention |
Primary outcome
anxiety, depression, and stress (DASS-42)
Time frame: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks
Change from baseline in anxiety, depression, and stress levels. Each of the three DASS scales contains 14 items. Using a 4-point Likert scale, scores range from 0- 42 for each scale. Higher scores indicate more depression, anxiety, and stress.
1 secondary outcome
COVID specific anxiety (CAS scale)
Time frame: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 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 31 Mar 2022.
- Derived from this study: PubMed 34435971Douglas SL, Plow M, Packer T, Lipson AR, Lehman MJ. Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Aug 26;10(8):e30617. doi: 10.2196/30617.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-coaching and Website in people with Multiple Sclerosis and Caregivers, run by Case Western Reserve 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 31 Mar 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?
anxiety, depression, and stress (DASS-42) (time frame: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks). 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 NCT04662008, which also lists 1 linked publication.
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 31 Mar 2022.