Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program

Multiple Sclerosis Clinical Trial

Official title:

Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954717
• Other study ID #: 1371420
• Status: Completed
• Start date: May 14, 2019
• Est. completion date: March 11, 2022

Study information

• Verified date: July 2023
• Source: Shepherd Center, Atlanta GA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study also evaluates the impact of the CAN DO Program on support partners.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CAN DO Program group: have MS and participated in the May 2019 Shepherd CAN DO Program

• CG-iCMS: Have MS

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Behavioral:
• Shepherd CAN DO Program
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.

Locations

Country	Name	City	State
United States	Shepherd Center	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Shepherd Center, Atlanta GA	Can Do Multiple Sclerosis, Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	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	12 months
Primary	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	24 months
Primary	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.	6 months
Primary	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.	12 months
Primary	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.	24 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months