Effectiveness of In-Clinic Rehabilitation vs. Home-Based Telerehabilitation for Adults with MS in the Deep South: The TEAMS Cluster Randomized Trial.

Objective

To compare the effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (pwMS) delivered by a therapist in a clinic (DirectCAM) versus self-initiated at home (TeleCAM).

Design

Pragmatic cluster-randomized controlled trial.

Setting

Forty-three clinics across Alabama, Mississippi, and Tennessee.

Participants

A total of 759 adults with MS were enrolled (DirectCAM, n=382; TeleCAM, n=377). Eligible participants were aged 18-70 years, self-reported a diagnosis of MS, had a Patient-Determined Disease Steps (PDDS) score between 0 and 7, were able to use their arms or legs for exercise, and had physician clearance.

Interventions

Participants received the same 12-week CAM exercise program delivered either onsite by a therapist (DirectCAM) or at home using preloaded exercise videos (TeleCAM). MAIN OUTCOME MEASURE(S) Patient-reported outcomes included the Modified Fatigue Impact Scale (MFIS), the 36-Item Short Form Health Survey (SF-36) Pain domain, the SF-36 physical and mental component scores, and Godin Leisure-Time Exercise Questionnaire (GLTEQ). Performance-based outcomes included the Berg Balance Scale (BBS), the Five Times Sit-to-Stand Test (FTSST), the Timed Up and Go (TUG) test, the Timed 25-Foot Walk (T25-FW), the six-minute walk test (6MWT), and grip strength. Outcomes were assessed at baseline and 3, 6, and 12 months.

Results

Of the 759 participants across 43 clinics, 382 were assigned to DirectCAM and 377 to TeleCAM. No statistically significant between-group differences were observed for patient-reported outcomes at 3, 6, or 12 months. For performance-based outcomes, improvement in BBS from baseline to 12 months was greater in DirectCAM than TeleCAM (2.1 [95% CI, 1.4-2.9], adjusted P<.001). No statistically significant between-group differences were observed for changes in 6MWT, FTSST, or T25-FW.

Conclusions

DirectCAM and TeleCAM produced comparable improvements in patient-reported outcomes. DirectCAM was superior only for BBS. Therefore, the hypothesis that TeleCAM would be superior to DirectCAM was not supported.