Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03117881 |
| Other study ID # |
F161017003 |
| Secondary ID |
MS-1511-33653 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2018 |
| Est. completion date |
October 30, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare the effects of two delivery models of an
evidence-based complementary alternative medicine (CAM) program that combines
neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with
multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different
delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM).
Participants will be randomly assigned to one of these two groups.
**On March 16th, 2020, the University of Alabama at Birmingham halted all onsite
non-essential research in response to the Covid-19 pandemic. Since then, the study has begun
to conduct all testing remotely through videoconferencing technology. In addition, another
study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue
the 12-week program delivery for newly recruited participants via videoconferencing
technology.**
Description:
There are few primary care and multiple sclerosis (MS) clinics that provide full exercise and
rehabilitation services for patients with MS, especially in mostly rural, low-income areas
such as Alabama, Mississippi, and Tennessee. Telerehabilitation, or the delivery of
rehabilitation services over the telephone and/or the Internet, can help fill service gaps
for underserved MS patient populations in this region. The proposed study will determine if
our evidence-based rehabilitation and exercise program produces similar health outcomes when
delivered in clinic or at home, using pre-loaded tablets and Interactive Voice Response (IVR)
system technology among 759 participants with MS from 40 clinics across Alabama, Mississippi,
and Tennessee.
**In response to the Covid-19 pandemic, the study aims to recruit 74 participants with MS
into the rDirectCAM, where the 12-week program is delivered in real-time via
videoconferencing technology. The rDirectCAM will determine if a telehealth rehabilitation
program can have a similar effect as when the program is offered in person.**
The outcomes that we hope to achieve through the proposed rehabilitation and exercise
program, referred to as complementary alternative medicine, are improved physical activity,
decreased pain and fatigue, and quality of life. We also seek to improve attitudes and
behaviors related to physical activity, such as outcome expectations for physical activity,
social support from family and friends for physical activity, self-efficacy (i.e., confidence
in one's ability to be active), and self-regulation (i.e., setting exercise goals). We will
examine the variation in outcomes by patient characteristics such as age and severity of
disability to determine for whom the intervention is effective.
This project is important to patients with MS because it seeks to reduce their barriers to
receiving exercise treatment and increase the convenience and appeal of such programs through
technology. Furthermore, findings and resources from this study will be quickly provided to
MS patients and clinicians across the United States (e.g., via training webinars through our
National Center on Health, Physical Activity, and Disability [NCHPAD]) and thereby improve
the quality and reach of exercise treatment for patients with MS.
The patient and stakeholder partners include MS patients, caretakers, and clinicians, who
have been actively guiding the development of this project. In stakeholder meetings, members
have provided insight into exercise treatment needs and preferences (e.g., individually
tailored approaches that account for varying levels of mobility); outcomes of interest to the
patient population (e.g., pain, fatigue, quality of life); and strategies for
engaging/motivating participants with MS who may be discouraged and experiencing fatigue and
pain (e.g., IVR calls and feedback). Moreover, their ongoing program satisfaction feedback
will be important to our recruitment and retention success. Finally, the stakeholders will
help make this project successful by continuing to emphasize the importance of long-term
gains in health outcomes and promote (through NCHPAD) the sustainability of the program.
