Table 5.
Study details and results from all identified studies of SmartInhaler™ (adherence, clinical outcomes, and health care resources use)
| Study name | Study objective | Study design | Indication | Sample size | Follow-up period | Key results |
|---|---|---|---|---|---|---|
| Britto et al (2017)52 | To evaluate if the text messaging intervention (using Smart Inhaler™) would result in improved adherence to prescribed ICS | RCT | Asthma | 64 | 6 months | • Patient age (mean ± SD) was 17.2±1.9 years in the intervention group and 17.4±2.7 years in the control group • Receiving the text intervention resulted in an increase in adherence of 2.75% each month relative to no intervention (P<0.01); improvements were not sustained • There was modest improvement in asthma control and quality of life outcomes in the text messages group compared with control group (scores at different timepoints mentioned in figures and not reported in text in the publication) • The adolescent participants gave high ratings on the acceptability of the text messaging system |
| Burgess et al (2010)a,49 | To assess the impact of measuring adherence and providing feedback on medication usage by children with unstable asthma | RCT | Asthma | 26 | 4 months | • Patient age varied between 6 and 14 years. Mean age of patients in the intervention group was 9.1 years and in the control group was 9.3 years • Adherence was significantly higher in the intervention group than in the control group (79% vs 58%, P<0.01) • Adherence in the control group declined slightly over the study; mean adherence in the intervention group increased from 76.8% during the third month to 84.2% over the final month (P<0.01) • There was a significant improvement in asthma control in both the intervention and the control groups: at baseline, 15 of 26 subjects reported using their reliever medication three or more times/week over the previous month. During the 4-month study, two subjects reported requiring reliever medication on average three or more times/week (P=0.02) • At baseline, mean FEV1 across all subjects was 75% predicted; mean FEV1 of all participants during the study increased to 85.2% • The change in FEV1 from baseline (% predicted) was greater in those subjects receiving feedback (13.8% vs 9.8%; P<0.9) • The change in FEV1 in the final month (% predicted) was similar in both groups (87.3% vs 86.9%; P<0.4) |
| Chan et al (2015)a,48 | To investigate whether use of an inhaler with audiovisual reminders improves adherence and asthma outcomes in children presenting with asthma exacerbation | RCT | Asthma | 220 | 6 months | • Patient age (mean ± SD) was 8.9±2.5 years in the intervention group and 8.9±2.6 in the control group • Median percentage adherence was 84% in the intervention group, compared with 30% in the control group (P<0.0001) • Intervention group had an improved asthma morbidity score (P=0.008) and asthma control scores at 2, 4, and 6 months (P<0.0001), and fewer exacerbations at 2 months (6% vs 24%, P=0.015) • Mean percentage adherence at 2, 4, and 6 months was 91%, 84%, and 79%, respectively, for the intervention group, compared with 40%, 33%, and 27%, respectively, for the control group • The change in asthma morbidity score from baseline to 6 months was significantly greater in the intervention group than in the control group (P=0.008). There was a reduction of 2.0 points from a mean baseline score of 9.3 (SD 2.2) to 7.3 (2.1) in the intervention group vs 1.2 points from a baseline of 9.2 (2.5) to 8.0 (2.2) in the control group • For childhood asthma control test scores, the difference between groups was significant at all timepoints (2, 4, and 6 months; P<0.0001), with the intervention group scoring higher by an overall average of 1.57 • The median percentage number of days on which a reliever was used was 9.5% in the intervention group and 17.4% in the control group (P=0.002) • No differences in FEV1 (P=0.38), asthma-related school absences (P=0.096), emergency visits (P=0.509), or caregiver work absences (P=0.167) were reported |
| Charles et al (2007)a,50 | To determine whether an audiovisual reminder device improves adherence with ICS therapy in adult asthma patients | RCT | Asthma | 110 | 6 months | • Median (range) patient age was 39 (13–65) years in the intervention group and 35 (15–64) years in the control group • In the last 12 weeks, the proportion of medication taken was 93% in the AVRF group and 74% in the control group, with a difference of 18% (95% CI 10, 26; P<0.0001) • The proportion of subjects taking >50%, >80%, or >90% of medication was greater in the AVRF group. Corresponding ratios of proportions adherent were 1.33 (95% CI 1.10, 1.61; P=0.003), 2.27 (95% CI 1.56, 3.3; P<0.0001), and 3.25 (95% CI 1.74, 6.1%; P<0.0001), respectively |
| Foster et al (2014)a,51 | To test the effectiveness of two brief GP-delivered interventions (with and without IRF) for improving adherence and asthma control | Cluster RCT | Asthma | 143 | 6 months | • Patient age (mean ± SD) was 40.3±15.2 years • Adherence was significantly higher in the IRF group vs non-IRF groups (73%±26% vs 46±28%; P<0.0001), but not significantly different between PAD and non-PAD • The asthma control improved overall (mean change in ACT score, 4.5±4.9; P<0.0001), with no significant difference between IRF and non-IRF groups • Severe exacerbations experienced by 11% patients in IRF groups and 28% in non-IRF groups (P=0.013; after adjustment for exacerbation history; P=0.06) • There were statistically significant and clinically important improvements from T0 to T6 months in asthma-related QoL (mean change, 0.77±1.15; P<0.0001) and significant improvements in anxiety (−0.93±3.18; P=0.022) and self-reported adherence behavior (MARS-A, 0.28±0.82; P=0.008); no significant difference between IRF and non-IRF groups |
| Jochmann et al (2015)78 | To compare self-assessment of adherence in children with difficult asthma with adherence measured electronically | Prospective, single-arm | Asthma | 50 | 16 weeks | • Median (range) patient age was 12.4 (5–17) years • Median SmartInhaler adherence was 60% (range 24%–97%) • FENO improved significantly in those with SmartInhaler adherence >80% • FEV1 improved significantly following monitoring (86 at baseline to 91.5 at follow-up; P=0.01) • mPAQLQ also improved significantly following monitoring (5.1 at baseline to 5.8 at follow-up; P=0.02) |
| Kenyon et al (2016)53 | To assess feasibility and acceptability of a health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care | Prospective, single-arm | Asthma | 14 | 3 months | • Median (range) patient age was 3.5 (3–9) years • All caregivers viewed the electronic monitoring device favorably and would recommend it to friends; 56% believed the device helped to improve asthma control • Overall, ACT scores improved by a mean of 2.7 points (95% CI 0, 5.5; P=0.05) over the 3-month intervention (just below the minimally significant ACT change threshold of 3 points) |
| Morton et al (2017)a,47 | To determine whether electronic monitoring results in improved clinical outcomes in asthma patients (STAAR study) | Open-label, parallel group, RCT | Asthma | 90 | 12 months | • Patient age (mean ± SD) was 10.4±2.9 years in the intervention group and 10.2±2.9 in the control group • Adherence in the intervention group was 70% vs 49% in the control group (P ≤ 0.001) • No significant difference in change in ACQ, but intervention group required significantly fewer oral steroids courses and fewer hospital admissions compared with control group ○ Event rate (per 100 child days) for courses of oral steroids were 0.411 for the intervention arm compared with 0.676 for the control arm (P=0.008) ○ Event rate (per 100 child days) for hospital admissions was 0.0254 for the intervention arm compared with 0.129 for the control arm (P<0.001) • FEV1% improved in both treatment arms, with no significant difference between treatments at 12-months compared with baseline • Differences in GP visits in the two groups were not clinically significant |
Note:
a
Studies submitted to NICE.
Abbreviations: ACQ, Asthma Controlled Questionnaire; ACT, Asthma Control Test; AVRF, audiovisual reminder function; FENO, fractional exhaled nitric oxide; GP, general practitioner; ICS, inhaled corticosteroids; IRF, inhaler reminders and feedback; MARS-A, Medication Adherence Report Scale for Asthma; NICE, National Institute of Health & Clinical Excellence; PAD, personalized adherence discussion; PAQLQ, Pediatric Asthma Quality of Life Questionnaire; QoL, quality of life; RCT, randomized controlled trial; STAAR, STudy of Asthma Adherence Reminders.