Table 1.
Baseline sociodemographic and clinical characteristics of the mITT population.
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|---|---|---|---|---|
| CHARACTERISTICS | TOTAL | TX | SOC | p VALUE |
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| (N = 276) | (N = 133) | (N = 143) | TX VS SOC | |
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| Sociodemographic characteristics | ||||
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| Age (years), Mean (SD) | 68.21 (11.09) | 67.77 (11.71) | 68.61 (10.51) | 0.21 |
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| Age Group (years), N (%) | 0.62 | |||
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| 22–44 | 11 (3.99) | 7 (5.26) | 4 (2.80) | |
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| 45–64 | 60 (21.74) | 31 (23.31) | 29 (20.28) | |
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| 65–74 | 124 (44.93) | 56 (42.11) | 68 (47.55) | |
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| ≥75 | 81 (29.35) | 39 (29.32) | 42 (29.37) | |
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| Gender, N (%) | 0.31 | |||
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| Male | 183 (66.30) | 84 (63.16) | 99 (69.23) | |
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| Female | 93 (33.70) | 49 (36.84) | 44 (30.77) | |
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| Race, N (%) | 0.31 | |||
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| Black | 5 (1.81) | 1 (0.75) | 4 (2.80) | |
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| White | 233 (84.42) | 115 (86.47) | 118 (82.52) | |
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| Hispanic | 3 (1.09) | 1 (0.75) | 2 (1.40) | |
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| Asian | 3 (1.09) | 3 (2.26) | 0 | |
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| More than one race | 3 (1.09) | 2 (1.50) | 1 (0.70) | |
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| Other | 4 (1.45) | 1 (0.75) | 3 (2.10) | |
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| Unknown | 25 (9.06) | 10 (7.52) | 15 (10.49) | |
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| Payers, N (%) | 0.37 | |||
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| Commercial insurance | 88 (31.88) | 46 (34.59) | 42 (29.37) | |
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| Medicare Advantage | 188 (68.12) | 87 (65.41) | 101 (70.63) | |
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| Clinical characteristics | ||||
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| Comorbidities | ||||
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| Charlson Comorbidity Index (CCI), Mean (SD) | 2.23 (2.50) | 2.06 (2.54) | 2.38 (2.46) | 0.73 |
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| Age-adjusted CCI, Mean (SD) | 4.78 (2.94) | 4.58 (3.00) | 4.96 (2.87) | 0.62 |
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| Number of comorbidities | 0.99 | |||
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| Mean (SD) | 7.20 (3.48) | 7.26 (3.56) | 7.15 (3.42) | |
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| Median (IQR) | 7 (5–9) | 7 (4–9) | 7 (5–9) | |
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| Psychiatric conditions, N (%) | ||||
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| Anxiety | 87 (31.52) | 40 (30.08) | 47 (32.87) | 0.62 |
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| Depression | 69 (25.00) | 34 (25.56) | 35 (24.48) | 0.83 |
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| Substance use disorders | 28 (10.14) | 11 (8.27) | 17 (11.89) | 0.32 |
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| Stress and adjustment disorders | 20 (7.25) | 9 (6.77) | 11 (7.69) | 0.77 |
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| Medication use, N (%) | ||||
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| ET medications | ||||
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| Primidone | 74 (26.81) | 41 (30.83) | 33 (23.08) | 0.15 |
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| Propranolol | 58 (21.01) | 22 (16.54) | 36 (25.17) | 0.10 |
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| Topiramate | 23 (8.33) | 10 (7.52) | 13 (9.09) | 0.64 |
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| Gabapentin | 41 (14.86) | 20 (15.04) | 21 (14.69) | 0.93 |
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| Other beta blockers | 143 (51.81) | 73 (54.89) | 70 (48.93) | 0.32 |
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| Other benzodiazepines | 15 (5.43) | 10 (7.52) | 5 (3.50) | 0.19 |
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| Alprazolam | 21 (7.61) | 12 (9.02) | 9 (6.29) | 0.50 |
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| Clonazepam | 12 (4.35) | 5 (3.76) | 7 (4.90) | 0.77 |
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| Any ET related medication | 193 (69.93) | 96 (72.18) | 97 (67.83) | 0.43 |
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| Number of ET-related Medications | 0.28 | |||
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| None | 83 (30.07) | 37 (27.82) | 46 (32.17) | |
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| 1 | 61 (22.10) | 26 (19.55) | 35 (24.48) | |
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| 2 | 83 (30.07) | 47 (35.34) | 36 (25.17) | |
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| 3 | 39 (14.13) | 20 (15.04) | 19 (13.29) | |
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| ≥4 | 10 (3.62) | 3 (2.26) | 7 (4.90) | |
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| Tremor Characteristics | ||||
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| Baseline BF-ADL severity*, N (%) | ||||
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| BF-ADL severity ≥2 | 262 (94.93) | 128 (96.24) | 134 (93.71) | 0.41 |
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| BF-ADL severity ≥3 | 224 (81.20) | 112 (84.21) | 112 (78.32) | 0.22 |
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| BF-ADL severity = 4 | 75 (27.17) | 34 (25.56) | 41 (28.67) | 0.59 |
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* BF-ADL tasks associated with eating, drinking, or writing (i.e., use a spoon to drink soup; hold a cup of tea; pour milk from a bottle; write a letter). Patients were classified as having at least one of these 4 BF-ADL tasks with a score of ≥2, ≥3, or = 4.
** See Supplementary Materials (Table S1) for additional sociodemographic and clinical characteristics.