Table 1.
Participant characteristics, pre-intervention adherence and Coach contact time
| Control (n = 88) |
Intervention (n = 81) |
|
|---|---|---|
|
| ||
| Demographics | ||
|
| ||
| Median age in | 15.8 (13.3 – 17.5) | 15.5 (13.2 – 17.4) |
|
| ||
| Male (%) | 54 (61) | 46 (57) |
|
| ||
| Race | ||
| White (%) | 57 (65) | 57 (70) |
| Black (%) | 11 (13) | 9 (11) |
| Asian (%) | 7 (8) | 4 (5) |
| Other (%) | 13 (15) | 11 (14) |
|
| ||
| Hispanic (%) | 5 (6) | 9 (11) |
|
| ||
| U.S. Study site (%) | 56 (64) | 54 (67) |
|
| ||
| Healthcare Insurer | ||
| U.S. Public | 20 (23) | 26 (32) |
| Private | 36 (41) | 28 (25) |
| Canadian provincial | 32 (36) | 27 (33) |
|
| ||
| Medication Insurer | ||
| U.S. Public | 24 (27) | 27 (33) |
| Private | 54 (61) | 42 (52) |
| Canadian provincial | 10 (11) | 12 (15) |
|
| ||
| Household income | ||
| Less Than $25,000 | 10 (11) | 19 (24) |
| $25,000 – $50,000 | 20 (23) | 17 (21) |
| $51,000 – $75,000 | 22 (25) | 17 (2) |
| $76,000 – $100,000 | 9 (10) | 6 (7) |
| Greater Than $100,000 | 16 (18) | 12 (15) |
| Prefer Not to Answer | 2 (2) | 5 (6) |
| Unknown | 9 (10) | 5 (6) |
|
| ||
| Disease characteristics | ||
|
| ||
| Median years post-Tx | 3.0 (0.8 – 7.2) | 3.7 (0.7 – 7.9) |
|
| ||
| Total no. of Tx | ||
| 1 | 81 (92) | 74 (91) |
| 2 | 7 (8) | 7 (9) |
|
| ||
| Donor source | ||
| Living | 51 (58) | 37 (46) |
| Deceased | 37 (42) | 44 (54) |
|
| ||
| Median total lifetime duration of dialysis, mo | 5.0 (0 – 12.0) | 10.0 (0.1 – 19.0) |
|
| ||
| Median age at Tx in years | 12.0 (8.3 – 15.2) | 11.5 (6.8 – 14.8) |
|
| ||
| Primary disease | ||
| CAKU (%) | 41 (47) | 29 (36) |
| Glomerulonephritis (%) | 5 (6) | 9 (11) |
| FSGS (%) | 6 (7) | 14 (17) |
| Other (%) | 36 (41) | 29 (36) |
|
| ||
| Number of past acute rejections | ||
| 0 (%) | 76 (86) | 59 (73) |
| 1 (%) | 8 (9) | 16 (20) |
| ≥2 (%) | 4 (5) | 6 (7( |
|
| ||
| Comorbidities | ||
| None | 43 (49) | 41 (51) |
| ≥1* | 45 (51) | 40 (49) |
|
| ||
| Median eGFR at baseline (ml/min/1.73m2; IQR) | 70.2 (56.0 – 85.9) | 69.4 (56.8 – 82.5) |
|
| ||
| Treatment characteristics: | ||
|
| ||
| No. of doses of immunosuppressives per day (%) | ||
| 1 | 6 (7) | 6 (7) |
| 2 | 82 (93) | 75 (93) |
|
| ||
| Median total number of medications (IQR) | 7.0 (5.0 – 9.0) | 7.0 (5.0 – 9.0) |
|
| ||
| Pre-intervention adherence and barriers | ||
|
| ||
| Run-in electronic adherence data | ||
| Days with 100% taking adherencea | 75% | 73% |
| Days with 100% timing adherence a | 67% | 65% |
|
| ||
| SD of Tac levels in the 6 mo before intervention | ||
| Once per day formulation* | 1.0 ± 0.4 | 1.1 ± 0.5 |
| Twice per day formulation** | 2.0 ± 1.7 | 2.2 ± 1.9 |
|
| ||
| Self-reported adherence (MAM; enrollment) | ||
| Taking adherence | 97.6 ± 7.1 | 98.8 ± 3.6 |
| Timing adherence | 92.9 ± 15.1 | 94.3 ± 12.2 |
|
| ||
| AMBS† | ||
| Total score | 38.1 ± 9.8 | 37.5 ± 11.2 |
| Disease frustration/ adolescent issues subscale | 19.5 ± 6.0 | 18.4 ± 6.6 |
| Ingestions issues subscale | 10.3 ± 3.3 | 10.3 ±3.5 |
| Regimen tasks/ cognitive subscale | 8.3 ± 2.8 | 8.7 ± 3.3 |
| Number of barriers reported | 3.2 ± 2.5 | 3.4 ± 2.7 |
| Proportion with ≥3 barriers (%) | 46 (52) | 43 (53) |
|
| ||
| PMBS✧ | ||
| Total score | 37.5 ± 10.3 | 34.0 ± 9.7 |
| Disease frustration/ adolescent issues subscale | 16.5 ± 5.3 | 14.4 ± 4.9 |
| Ingestions issues subscale | 6.3 ± 2.4 | 5.7 ± 2.4 |
| Regimen tasks/ cognitive subscale | 12.0 ± 4.6 | 10.9 ± 4.2 |
| Parent reminder subscale | 2.7 ± 1.4 | 3.0 ± 1.5 |
| Number of barriers reported | 3.8 ± 2.9 | 3.1 ± 2.4 |
| Proportion with ≥3 barriers (%) | 46 (58) | 37 (51) |
|
| ||
| Time in study and coach contact time | ||
|
| ||
| Run-in interval | ||
|
| ||
| Median patient-months | 3.1 (2.8 – 3.5) | 3.2 (2.9 – 3.6) |
|
| ||
| Proportion of days with no adherence score | 4.6% (0.0% – 22.7%) | 3.7% (0% – 14.1%) |
|
| ||
| Median time spent with coach at enrolment visit (min) | 45.0 (40.0 – 60.0) | 45.0 (40.0 – 60.0) |
|
| ||
| Intervention interval | ||
|
| ||
| Median patient-months | 12.4 (11.4 – 13.0) | 12.2 (11.3 – 13.3) |
|
| ||
| Proportion of days with no adherence score | 4.5% (1.1% – 10.7%) | 5.5% (2.3% – 15.0%) |
|
| ||
| Proportion of days on Medminder | 19.8% | 32.6% |
|
| ||
| Median time spent with coach (min) | ||
| 1st Intervention visit (at 3 mo) | 26.5 (22.0 – 33.5) | 80.0 (62.5 – 96.0) |
| 6-mo visit | 25.0 (20.0 – 30.0) | 40.0 (35.0 – 55.0) |
| 9-mo visit | 23.5 (20.0 – 30.0) | 35.0 (30.0 – 44.6) |
| 12-mo visit | 21.6 (20.0 – 27.0) | 31.5 (27.0 – 40.0) |
| 15-mo visit | 30.0 (25.0 – 40.0) | 35.0 (30.0 – 45.0) |
|
| ||
| Proportion of visits at which a caregiver was present | 100% (68% – 100%) | 100% (60% – 100%) |
SD, standard deviation; AMBS, adolescent-reported adherence barriers score; PMBS, parent-reported adherence barriers; Tac, tacrolimus; Tx, transplantation
Except as indicated, categorical data presented as count (percentage), continuous data as median [interquartile range] or mean +/− SD.
9 control and 6 intervention patients with ≥3 trough levels available to calculate SD
55 control and 47 intervention patients with ≥3 trough levels available to calculate SD
A higher AMBS score represents a greater burden of barriers. The possible range for total score is 17–85; subscale scores range from 7–35 for Disease frustration/adolescent issues, 6–30 for Ingestion issues, and 4–20 for Regimen adaptation/ Cognitive.
A higher PMBS score represents a greater burden of barriers. The possible range for total score is 16–80; subscale scores range from 7–35 for Disease frustration/adolescent issues, 3–15 for Ingestion issues, 5–25 for Regimen adaptation/ Cognitive, and 1–5 for Parent reminder.
all prescribed doses taken