Table 1.
Demographic and Clinical Characteristics at Baseline, Hearing Aid Use, and Cognitive Outcomes of ACHIEVE Participants Stratified by Randomised Treatment Assignment and Recruitment Source (N=977)
| Total (N=977) | ARIC (N=238) | De novo (N=739) | ||||||
|---|---|---|---|---|---|---|---|---|
| Intervention | Control | Intervention | Control | Intervention | Control | |||
| N | All | (N=490) | (N=487) | (N=120) | (N=118) | (N=370) | (N=369) | |
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Baseline Age, mean (SD), y |
977 | 76.8 (4.0) | 76.5 (3.9) | 77.0 (4.0) | 79.2 (2.9) | 78.6 (2.9) | 75.7 (3.8) | 76.5 (4.2) |
| Female sex, No. (%) | 977 | 523 (53.5) | 264 (53.9) | 259 (53.2) | 74 (61.7) | 73 (61.9) | 190 (51.4) | 186 (50.4) |
| Black race, No. (%) | 977 | 112 (11.5) | 53 (10.8) | 59 (12.1) | 33 (27.5) | 35 (29.7) | 20 (5.4) | 24 (6.5) |
| White race, No. (%) Field site, No. (%) |
977 | 858 (87.8) | 434 (88.6) | 424 (87.1) | 86 (71.7) | 83 (70.3) | 348 (94.1) | 341 (92.4) |
| Forsyth County, North Carolina | 977 | 236 (24.2) | 117 (23.9) | 119 (24.4) | 31 (25.8) | 30 (25.4) | 86 (23.2) | 89 (24.1) |
| Jackson, Mississippi | 243 (24.9) | 120 (24.5) | 123 (25.3) | 30 (25.0) | 33 (28.0) | 90 (24.3) | 90 (24.4) | |
| Minneapolis, Minnesota | 236 (24.2) | 120 (24.5) | 116 (23.8) | 21 (17.5) | 22 (18.6) | 99 (26.8) | 94 (25.5) | |
| Washington County, Maryland Education, No. (%) |
262 (26.8) | 133 (27.1) | 129 (26.5) | 38 (31.7) | 33 (28.0) | 95 (25.7) | 96 (26.0) | |
| Less than high school | 976 | 37 (3.8) | 19 (3.9) | 18 (3.7) | 12 (10.1) | 10 (8.5) | 7 (1.9) | 8 (2.2) |
| High school, GED, or vocational school | 418 (42.8) | 206 (42.1) | 212 (43.5) | 48 (40.3) | 48 (40.7) | 158 (42.7) | 164 (44.4) | |
| College, graduate, or professional school | 521 (53.4) | 264 (54.0) | 257 (52.8) | 59 (49.6) | 60 (50.8) | 205 (55.4) | 197 (53.4) | |
| One or more APOE £4 alleles, No. (%) | 908 | 224 (24.7) | 110 (24.5) | 114 (24.8) | 26 (23.0) | 33 (28.2) | 84 (25.0) | 81 (23.7) |
| Diabetes, No. (%) | 977 | 195 (20.0) | 104 (21.2) | 91 (18.7) | 36 (30.0) | 32 (27.1) | 68 (18.4) | 59 (16.0) |
| Hypertension, No. (%) | 974 | 651 (66.8) | 333 (68.0) | 318 (65.7) | 87 (72.5) | 82 (71.3) | 246 (66.5) | 236 (64.0) |
| Living alone, No. (%) Income, No. (%) | 967 | 290 (30.0) | 153 (31.6) | 137 (28.4) | 44 (37.9) | 39 (33.9) | 109 (29.6) | 98 (26.6) |
| Under $25,000 | 950 | 147 (15.5) | 73 (15.3) | 74 (15.7) | 29 (25.4) | 31 (27.9) | 44 (12.1) | 43 (11.9) |
| $25,000–$49,999 | 283 (29.8) | 156 (32.6) | 127 (26.9) | 47 (41.2) | 30 (27.0) | 109 (29.9) | 97 (26.9) | |
| $50,000–$74,999 | 210 (22.1) | 91 (19.0) | 119 (25.2) | 22 (19.3) | 25 (22.5) | 69 (19.0) | 94 (26.0) | |
| $75,000–$100,000 | 140 (14.7) | 68 (14.2) | 72 (15.3) | 8 (7.0) | 13 (11.7) | 60 (16.5) | 59 (16.3) | |
| Over $100,000 | 170 (17.9) | 90 (18.8) | 80 (16.9) | 8 (7.0) | 12 (10.8) | 82 (22.5) | 68 (18.8) | |
| Pure tone average, mean (SD), dB Baseline & Follow-Up |
977 | 39.4 (6.9) | 39.5 (7.1) | 39.3 (6.7) | 39.5 (6.7) | 38.7 (6.7) | 39.6 (7.2) | 39.5 (6.8) |
| Hearing handicap inventory, mean (SD), Baseline | 970 | 15.3 (9.8) | 15.7 (10.2) | 14.9 (9.3) | 12.7 (10.3) | 11.4 (8.6) | 16.7 (9.9) | 16.0 (9.3) |
| Year One | 926 | 9.8 (9.0) | 5.7 (5.9) | 14.0 (9.8) | 5.1 (5.4) | 10.1 (7.3) | 5.9 (6.0) | 15.3 (10.1) |
| Year Two | 892 | 10.3 (9.2) | 6.6 (6.6) | 14.0 (9.9) | 5.1 (6.0) | 10.2 (8.3) | 7.1 (6.6) | 15.3 (10.1) |
| Year Three | 863 | 12.0 (9.6) | 7.8 (7.3) | 16.2 (9.9) | 7.6 (8.6) | 12.4 (9.2) | 7.8 (6.8) | 17.4 (9.8) |
| Mini-mental state exam, mean (SD), Baseline | 977 | 28.2 (1.6) | 28.2 (1.6) | 28.2 (1.6) | 28.1 (1.7) | 27.9 (1.8) | 28.3 (1.6) | 28.3 (1.5) |
| Year Three | 856 | 27.8 (2.3) | 27.9 (2.4) | 27.7 (2.2) | 26.9 (2.8) | 26.6 (2.7) | 28.2 (2.1) | 28.0 (1.8) |
| Global cognition, mean (SD), Baseline | 977 | 0.000 (0.926) | 0.012 (0.949) | −0.011 (0.902) | −0.411 (1.024) | −0.346 (1.062) | 0.149 (0.883) | 0096 (0.818) |
| Year Three | 859 | −0.161 (1.098) | −0.136 (1.139) | −0.186 (1.057) | −0.604 (1.274) | −0.643 (1.156) | −0.001 (1.060) | −0.037 (0.980) |
| Executive function, mean (SD), Baseline | 977 | −0.001 (0.888) | 0.020 (0.897) | −0.021 (0.879) | −0.327 (1.042) | −0.310 (0.958) | 0.132 (0.815) | 0.072 (0.833) |
| Year Three | 856 | −0.236 (1.060) | −0.224 (1.096) | −0.248 (1.025) | −0.608 (1.228) | −0.652 (1.122) | −0.112 (1.029) | −0.116 (0.956) |
| Language, mean (SD), Baseline | 977 | 0.000 (0.837) | −0.011 (0.851) | 0.012 (0.823) | −0.436 (0.883) | −0.352 (0.965) | 0.126 (0.794) | 0.128 (0.737) |
| Year Three | 859 | −0.115 (0.930) | −0.111 (0.949) | −0.119 (0.912) | −0.485 (1.026) | −0.563 (0.969) | −0.002 (0.898) | 0.025 (0.845) |
| Memory, mean (SD), Baseline | 977 | 0.000 (0.909) | 0.016 (0.938) | −0.016 (0.879) | −0.223 (0.918) | −0.159 (0.959) | 0.093 (0.933) | 0.030 (0.849) |
| Year Three Hours of hearing aid use per day, mean (SD) |
859 | 0.012 (1.070) | 0.067 (1.091) | −0.043 (1.046) | −0.220 (1.128) | −0.254 (1.116) | 0.151 (1.068) | 0.026 (1.015) |
| Year One | 470 | 8.1 (4.6) | 8.1 (4.6) | 7.2 (4.4) | 8.3 (4.7) | |||
| Year Two | 456 | 7.1 (5.0) | 7.1 (5.0) | 6.8 (4.8) | 7.2 (5.1) | |||
| Year Three | 431 | 7.2 (5.2) | 7.2 (5.2) | 5.8 (5.0) | 7.6 (5.2) | |||
| Intervention drop-in, No. (%) | 462 | 76 (16.5) | 76 (16.5) | 9 (7.8) | 67 (19.4) | |||
| Intervention drop-out, No. (%) | 488 | 10 (2.0) | 10 (2.0) | 5 (4.2) | 5 (1.4) | |||
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Abbreviations: ACHIEVE, Aging and Cognitive Health Evaluation in Elders; APOE, apolipoprotein E; ARIC, Atherosclerosis Risk in Communities; dB, decibels; GED, General educational development credential; SD, standard deviation; y, year. Sex (male/female) was based on self-report. Diabetes was defined as present if the participant reported using medication for diabetes or self-reported a physician diagnosis of diabetes. Sitting blood pressure was measured using a random zero sphygmomanometer. Hypertension was defined as present based on the use of antihypertensive medication, systolic blood pressure greater than or equal to 140 mm Hg, or diastolic blood pressure greater than or equal to 90 mm Hg. Income was based on participant self-report of all family income over the past 12 months. Factor scores of global cognition, executive function, language, and memory were developed using a validated latent variable modeling approach15 and standardized to the baseline with higher scores indicating better cognitive function. Hearing aid use is based on average self-reported hours of use per day.