Clinical trial NCT03954717: Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program
Official title: Pilot Study Evaluating Functional and Wellness Outcomes of the Shepherd CAN DO MS Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Shepherd Center, Atlanta GA
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
name: Can Do Multiple Sclerosis
First posted: 2019-05-17
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-efficacy for symptom management at 6 months
timeFrame: 6 months
measure: Change in self-efficacy for symptom management at 12 months
timeFrame: 12 months
measure: Change in self-efficacy for symptom management at 24 months
timeFrame: 24 months
measure: Change in self-efficacy for quality of life at 6 months
timeFrame: 6 months
measure: Change in self-efficacy for quality of life at 12 months
timeFrame: 12 months
measure: Change in self-efficacy for quality of life at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Change in caregiver perception of burden at 6 months
timeFrame: 6 months
measure: Change in caregiver perception of burden at 12 months
timeFrame: 12 months
measure: Change in caregiver perception of burden at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
Study officials:
affiliation: Shepherd Center, Atlanta GA
name: Deborah Backus, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: