Multiple SclerosisNCT03954717
Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program
An observational study of Multiple Sclerosis, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
The study evaluates the efficacy of the CAN DO Program for improving health, wellness, and quality of life in people with MS, and compares outcomes between people with MS who participate in the CAN DO Program to a control group of people with MS who do not participate in the CAN DO Program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Shepherd CAN DO Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2019to 11 Mar 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty-four people with MS and their support partners participating in the May 2019 Shepherd CAN DO Program, and two control groups (CG) matched to program participants for age, sex, type of MS, and level of disability: CG-S = 24 current patients of the MS Institute at Shepherd and their support partners willing to complete surveys via an electronic platform. CG-iCMS = 24 iConquerMS members and their support partners willing to complete the same outcomes. These participants can be from anywhere in the US, but cannot participate in any of the Can Do MS programs at any time prior to the study.
Who may be able to join
- CAN DO Program group: have MS and participated in the May 2019 Shepherd CAN DO Program
- CG-iCMS: Have MS
Who cannot join
- CAN DO Program group: Active members of the Shepherd Center MS Wellness Program, or who have previously been a participant in any CAN DO MS Programs.
- CG-iCMS: Cannot participate in any of the CAN DO MS Programs at any time prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the efficacy of the CAN DO Program for improving health, wellness, and quality of life in people with MS, and compares outcomes between people with MS who participate in the CAN DO Program to a control group of people with MS who do not participate in the CAN DO Program. The study also evaluates the impact of the CAN DO Program on support partners.
Read the detailed description
Can Do MS Programs offer evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a healthy life beyond their MS. The signature program of Can Do MS is the four-day CAN DO® Program (CAN DO). Preliminary outcomes suggest that participation in CAN DO leads to significant improvements in self-efficacy and various aspects of health status.1 The majority of 129 participants who participated in one of the three CAN DO Programs showed improvements in self-efficacy at one month (n=98), 3 months (n=84), and 6 months after the program (n=82; all p<0.001). Participants also showed significant improvements to varying degrees in subscales of the SF-36, including Physical Functioning (p=0.01), Role Physical, General Health, Vitality and Mental Health. These improvements were maintained to varying extents at one and 3 months post-program.
These important outcomes have not yet been compared to those in people with MS who receive traditional care but do not participate in this comprehensive educational opportunity. Furthermore, the impact on physical activity, participation, and quality of life has not been measured or compared to those who do not participate in CAN DO. Finally, recognizing the tremendous burden that can be placed on the support partner living and supporting a person with MS, education for support partners is another critical element of CAN DO. However, the impact on the support partner of empowering an individual with MS to adopt healthy behaviors also has not been assessed.
This project will allow Shepherd Center and Can Do MS to gather long-term health, wellness, and quality of life outcomes in people with MS and their support partners, as well as pilot data evaluating this study design for future larger scale clinical trials. Demonstrating the efficacy of this program will provide evidence that will impact the lives of people with MS and their families, specifically, their ability to live healthy lives independent of their MS.
- Conditions
- Multiple Sclerosis
- Being tested
- Shepherd CAN DO Program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shepherd CAN DO ProgramBehavioural
CAN DO Shepherd is a four-day participatory program held at the Shepherd Center, in Atlanta, Georgia or people with MS. The four-day program comprises evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a health life beyond their MS.
| Study group | Role | What they receive |
|---|---|---|
| Participants in the Shepherd CAN DO Program | People with MS enrolled into the Shepherd CAN DO Program. Receives: Behavioral: Shepherd CAN DO Program | |
| Control Group-Shepherd (CG-S) | People with MS who are current patients of the MS Institute at the Shepherd Center. | |
| Control Group-iConquerMS (CG-iCMS) | iConquerMS members | |
| Support partners of CAN DO | Support partners of the participants in the Shepherd CAN DO Program group Receives: Behavioral: Shepherd CAN DO Program | |
| CG-S support partners | Support partners of the people with MS in the CG-S group. | |
| CG-iCMS | Support partners of the people with MS in the CG-iCMS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy for symptom management at 6 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R)
Constructs measured:
- Healthcare provider relationship \& communication
- Treatment adherence/barriers
- Social/family support
- MS knowledge \& information
- Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Measured: 6 months
Change in self-efficacy for symptom management at 12 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R)
Constructs measured:
- Healthcare provider relationship \& communication
- Treatment adherence/barriers
- Social/family support
- MS knowledge \& information
- Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Measured: 12 months
Change in self-efficacy for symptom management at 24 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R)
Constructs measured:
- Healthcare provider relationship \& communication
- Treatment adherence/barriers
- Social/family support
- MS knowledge \& information
- Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Measured: 24 months
Change in self-efficacy for quality of life at 6 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Measured: 6 months
Change in self-efficacy for quality of life at 12 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Measured: 12 months
Change in self-efficacy for quality of life at 24 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Measured: 24 months
Secondary outcomes (3)
Change in caregiver perception of burden at 6 months
The extent to which caregivers of participants demonstrate decreased perception of caregiver burden as measured by the Zarit Burden Interview (ZBI) The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. 9. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: 6 months
Change in caregiver perception of burden at 12 months
The extent to which caregivers of participants demonstrate decreased perception of caregiver burden as measured by the Zarit Burden Interview (ZBI) The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. 9. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: 12 months
Change in caregiver perception of burden at 24 months
The extent to which caregivers of participants demonstrate decreased perception of caregiver burden as measured by the Zarit Burden Interview (ZBI) The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. 9. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start14 May 2019
- Primary completion11 Mar 2022
- Study completion11 Mar 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Can Do Multiple Sclerosis
- Responsible party
- Principal investigator, Deborah Backus, Shepherd Center, Atlanta GA
- Investigators
- Deborah Backus, PhD, PT, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954717
- Sponsor's protocol ID
- 1371420
- Status last verified
- Jul 2023
- First submitted
- 14 May 2019
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program
- ClinicalTrials.gov ID
- NCT03954717
- Acronym / sponsor ID
- 1371420
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Can Do Multiple Sclerosis
- Study start
- 14 May 2019 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 17 May 2019 (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.
The study evaluates the efficacy of the CAN DO Program for improving health, wellness, and quality of life in people with MS, and compares outcomes between people with MS who participate in the CAN DO Program to a control group of people with MS who do not participate in the CAN DO Program. The study also evaluates the impact of the CAN DO Program on support partners.
Detailed description
Can Do MS Programs offer evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a healthy life beyond their MS. The signature program of Can Do MS is the four-day CAN DO® Program (CAN DO). Preliminary outcomes suggest that participation in CAN DO leads to significant improvements in self-efficacy and various aspects of health status.1 The majority of 129 participants who participated in one of the three CAN DO Programs showed improvements in self-efficacy at one month (n=98), 3 months (n=84), and 6 months after the program (n=82; all p<0.001). Participants also showed significant improvements to varying degrees in subscales of the SF-36, including Physical Functioning (p=0.01), Role Physical, General Health, Vitality and Mental Health. These improvements were maintained to varying extents at one and 3 months post-program.
These important outcomes have not yet been compared to those in people with MS who receive traditional care but do not participate in this comprehensive educational opportunity. Furthermore, the impact on physical activity, participation, and quality of life has not been measured or compared to those who do not participate in CAN DO. Finally, recognizing the tremendous burden that can be placed on the support partner living and supporting a person with MS, education for support partners is another critical element of CAN DO. However, the impact on the support partner of empowering an individual with MS to adopt healthy behaviors also has not been assessed.
This project will allow Shepherd Center and Can Do MS to gather long-term health, wellness, and quality of life outcomes in people with MS and their support partners, as well as pilot data evaluating this study design for future larger scale clinical trials. Demonstrating the efficacy of this program will provide evidence that will impact the lives of people with MS and their families, specifically, their ability to live healthy lives independent of their MS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Participants in the Shepherd CAN DO Program | – | Behavioral: Shepherd CAN DO ProgramPeople with MS enrolled into the Shepherd CAN DO Program. |
| Control Group-Shepherd (CG-S) | – | –People with MS who are current patients of the MS Institute at the Shepherd Center. |
| Control Group-iConquerMS (CG-iCMS) | – | –iConquerMS members |
| Support partners of CAN DO | – | Behavioral: Shepherd CAN DO ProgramSupport partners of the participants in the Shepherd CAN DO Program group |
| CG-S support partners | – | –Support partners of the people with MS in the CG-S group. |
| CG-iCMS | – | –Support partners of the people with MS in the CG-iCMS group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-four people with MS and their support partners participating in the May 2019 Shepherd CAN DO Program, and two control groups (CG) matched to program participants for age, sex, type of MS, and level of disability: CG-S = 24 current patients of the MS Institute at Shepherd and their support partners willing to complete surveys via an electronic platform. CG-iCMS = 24 iConquerMS members and their support partners willing to complete the same outcomes. These participants can be from anywhere in the US, but cannot participate in any of the Can Do MS programs at any time prior to the study.
Key inclusion criteria (2 listed)
- CAN DO Program group: have MS and participated in the May 2019 Shepherd CAN DO Program
- CG-iCMS: Have MS
Key exclusion criteria (2 listed)
- CAN DO Program group: Active members of the Shepherd Center MS Wellness Program, or who have previously been a participant in any CAN DO MS Programs.
- CG-iCMS: Cannot participate in any of the CAN DO MS Programs at any time prior to 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 |
|---|---|---|
| Shepherd CAN DO ProgramCAN DO Shepherd is a four-day participatory program held at the Shepherd Center, in Atlanta, Georgia or people with MS. The four-day program comprises evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a health life beyond their MS. | Behavioural | Participants in the Shepherd CAN DO Program, Support partners of CAN DO |
Primary outcome
Change in self-efficacy for symptom management at 6 months
Time frame: 6 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R) Constructs measured: * Healthcare provider relationship \& communication * Treatment adherence/barriers * Social/family support * MS knowledge \& information * Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Change in self-efficacy for symptom management at 12 months
Time frame: 12 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R) Constructs measured: * Healthcare provider relationship \& communication * Treatment adherence/barriers * Social/family support * MS knowledge \& information * Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Change in self-efficacy for symptom management at 24 months
Time frame: 24 months
The extent to which participants demonstrate increased self-efficacy (the confidence in one's belief to undertake a task) to manage symptoms measured by the Multiple Sclerosis Self-Management Scale Revised (MSSM-R) Constructs measured: * Healthcare provider relationship \& communication * Treatment adherence/barriers * Social/family support * MS knowledge \& information * Health maintenance behavior 24 items, with score 1 (disagree completely) to 5 (agree completely) For some 1 is a positive outcome and for others 5 is a positive outcome; the scores and transformed and scaled for each participant
Change in self-efficacy for quality of life at 6 months
Time frame: 6 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Change in self-efficacy for quality of life at 12 months
Time frame: 12 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
Change in self-efficacy for quality of life at 24 months
Time frame: 24 months
The extent to which self-efficacy to undertake tasks related to quality of life increases over time as measured by the Exercise Self-Efficacy Scale (ESES) The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. For each item, participants indicate their confidence to execute the behavior on a 100-point percentage scale comprised of 10-point increments, ranging from 0% (not at all confident) to 100% (highly confident). Total strength for each measure of self-efficacy is then calculated by summing the confidence ratings and dividing by the total number of items in the scale, resulting in a maximum possible efficacy score of 100.
3 secondary outcomes
Change in caregiver perception of burden at 6 months
Time frame: 6 months
Change in caregiver perception of burden at 12 months
Time frame: 12 months
Change in caregiver perception of burden at 24 months
Time frame: 24 months
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 2 Aug 2023.
- 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.
Deborah Backus, PhD, PT principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Shepherd Center, Atlanta GA 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 2 inclusion and 2 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 2 Aug 2023. 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 for symptom management at 6 months (time frame: 6 months). The study lists 6 primary outcomes in all. 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 2 Aug 2023.