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Efficacy of a telephone-delivered self-management intervention for persons with multiple sclerosis: a randomized controlled trial with a one-year follow-up |
Ehde DM, Elzea JL, Verrall AM, Gibbons LE, Smith A, Amtmann D |
Archives of Physical Medicine and Rehabilitation 2015 Nov;96(11):1945-1958 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To evaluate the efficacy of a telephone-delivered self-management intervention for fatigue, pain, and depression in adults with multiple sclerosis (MS). DESIGN: Single-center, randomized (1:1), single blind (outcome assessors) parallel-group trial with a primary end-point of post-treatment (9 to 11 weeks post-randomization) and long-term follow-ups at 6- and 12-months. SETTING: Telephone-delivered across the United States. PARTICIPANTS: Adults with MS (n = 163) with fatigue, chronic pain, and/or moderate depressive symptoms (age range 25 to 76 years). INTERVENTIONS: Eight-week individual telephone-delivered self-management intervention (T-SM: n = 75) versus an eight-week individual telephone-delivered MS education intervention (T-ED: n = 88). MAIN OUTCOME MEASURES: The primary outcome was the proportion who achieved a > 50% decrease in one or more symptom-fatigue impact, pain interference, and/or depression severity. Secondary outcomes included continuous measures of pain, fatigue impact, depression, self-efficacy, activation, health-related quality of life, resilience, and affect. RESULTS: For our primary outcome, 58% of those in the T-SM and 46% of those in the T-Ed had a > 50% reduction in one or more symptom; this difference was not statistically significant (OR 1.50, 95% CI 0.77 to 2.93, p = 0.238). Participants in both groups significantly improved from baseline to post-treatment in primary and secondary outcome measures (p < 0.05). T-SM participants reported significantly higher treatment satisfaction and therapeutic alliance and greater improvements in activation, positive affect, and social roles. Improvements were generally maintained at 6- and 12-months. CONCLUSIONS: Both interventions resulted in short- and long-term, clinically meaningful benefits. The study demonstrated that the telephone is an effective method for engaging participants in and extending the reach of care for individuals with MS.
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