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

Shepherd Center, Atlanta GA

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Shepherd CAN DO Program

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03954717

1371420

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

111 participants in 6 patient groups

Participants in the Shepherd CAN DO Program

Description:

People with MS enrolled into the Shepherd CAN DO Program.

Treatment:

Behavioral: Shepherd CAN DO Program

Control Group-Shepherd (CG-S)

Description:

People with MS who are current patients of the MS Institute at the Shepherd Center.

Control Group-iConquerMS (CG-iCMS)

Description:

iConquerMS members

Support partners of CAN DO

Description:

Support partners of the participants in the Shepherd CAN DO Program group

Treatment:

Behavioral: Shepherd CAN DO Program

CG-S support partners

Description:

Support partners of the people with MS in the CG-S group.

CG-iCMS

Description:

Support partners of the people with MS in the CG-iCMS group