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

NCT03954717 | Completed

• 1 other identifier: 1371420
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Change in caregiver perception of burden at 6 months

  6 months

• Change in caregiver perception of burden at 12 months

  12 months

• Change in caregiver perception of burden at 24 months

  24 months

Study Arms (6)

Participants in the Shepherd CAN DO Program

People with MS enrolled into the Shepherd CAN DO Program.

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

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

Interventions

Shepherd CAN DO Program BEHAVIORAL

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.

Participants in the Shepherd CAN DO Program; Support partners of CAN DO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• CAN DO Program group: have MS and participated in the May 2019 Shepherd CAN DO Program
• CG-iCMS: Have MS

You may not qualify if:

• 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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Genzyme, a Sanofi Company: collaborator
• Can Do Multiple Sclerosis: collaborator

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Deborah Backus, PhD, PT

  Shepherd Center, Atlanta GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multiple Sclerosis Research

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: May 14, 2019
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)