Follow-up study outcomes between intervention and control groups
| Author (year) country | Intervention PROM | Length of follow-up | HbA1c | Depressive symptoms | Diabetes distress | Other PROM outcomes | Self-management |
| Cummings et al
40
(2019) USA | PHQ-9* DDS-17† | 12 months | 8.9% (2.1) vs 9% (2.2) p=0.06 | PHQ-9: 6.3 (5.9) vs 7.9 (7) p=0.01 | DDS (RDD): 2.1 (1.2) vs 2.6 (1.3) p=0.0001 | Not assessed | SDSCA: 4.3 (1.4) vs 3.98 (1.3) p=0.03 |
| Dobler et al
44
(2018) Germany | PAID†, PHQ-9* | 12 months | mean change −0.7% (1.4) vs 0.1% (1.7) p=0.006 | PHQ-9: mean change −1.35 (4.3) vs −0.23 (4.9) p=0.057 | PAID: mean change −4.77 (14.4) vs −1.4 (17) p=0.069 | WHO-5: 1.23 (5.7) vs 0.1 (5.8) p=0.044 | Not assessed |
| Ell et al
38
(2011) USA | PHQ-9* | 24 months | 9.1% (0.29) vs 8.9% (0.29) p=0.42 | PHQ-9 (reported as >50% reduction): adjusted OR=1.87, 95% CI (1.05 to 3.32) p=0.03 | Not assessed | SF-12 mental: 44.76 (1.150) vs 42.48 (1.17) p=0.001 | SDSCA: 3.6 (0.15) vs 3.41 (0.2) p=0.26 |
| Fortmann et al
42 (2020) USA | PHQ-2, PHQ-9* | 12 months | Mean change: −0.5% vs 0.0% p=0.011 | Only assessed in intervention arm | Only assessed in intervention arm | Not assessed | Only assessed in intervention arm |
| Johnson et al
41
(2014) USA | PHQ-9* | 12 months | Mean change: −0.2% (1.3) vs −0.2% (1.1) p=0.47 | PHQ-9: 7.1 (5.4) vs 9.4 (5.9) p≤0.001 | PAID-5: mean change −0.6 (0.8) vs 0.2 (0.9) p=0.03 | EQ-5D: mean change 0.03 (0.1) vs 0.04 (0.12) p=0.23 | Not assessed |
| Naik et al
37
(2019) USA | PHQ-9* | 12 months | 8.7% (1.6) vs 8.9% (2) p=0.83 | PHQ-9: 10.1 (6.9) vs 12.6 (6.5) p=0.03 | Not assessed | Not assessed | Not assessed |
| Rees et al
43 (2017) Australia | DDS† | 6 months | 7.1% (1.1) vs 8.4% (2.5) p=0.093 | PHQ-9: 6.7 (5.9) vs 9.9 (6.5) p=0.144 | DDS: 2.2 (1.1) vs 2.5 (0.8) p=0.427 | Not assessed | SDSCA diet: 6.1 (1.1) vs 5 (1.5) p=0.026 |
| Sigurdardottir et al
45
(2009) Iceland | PAID† | 6 months | 8.0% (1.16) vs 7.8% (.081) p=0.399 | Not assessed | PAID: 19.1 (12.9) vs 13.8 (12.6) p=0.239 | WBQ-12: 28.4 (6.1) vs 27.4 (5.6) p=0.544 | SDSCA diet: 3.6 (0.4) vs 3.4 (0.5) p=0.122 |
| Wu et al
39
(2018) USA | PHQ-2, PHQ-9* | 6 months | 8.1% (0.16) vs 8.0% (0.17) p=0.57 | PHQ-9: 5.16 (0.48) vs 6.35 (0.49) p=0.02 | Not assessed | SF-12 mental: 49.87 (1.02) vs 48.38 (1.04) p=0.17 Satisfaction with diabetes care 4.20 (0.09) vs 4.01 (0.09) p=0.05 | SDSCA: 4.78 (0.12) vs 4.66 (0.13) p=0.38 |
Outcome data are always presented as intervention versus control. Note, Johnson et al 41 was a case–control study involving three groups, with data related to intervention and active control represented here. Wu et al 39 was an observational study involving three groups, with data related to intervention versus usual care represented here.
Other PROM outcomes included general emotional well-being, mental health and health status, as well as satisfaction with diabetes care.
*indicates PROM related to depressive symtpoms.
†indicates PROM related to diabetes distress.
DDS, Diabetes Distress Scale; HbA1c, Glycated hemoglobin; 5-level EQ-5D, EuroQoL Five Dimensions; PAID, Problem Area in Diabetes scale; PHQ, Patient Health Questionnaire; PROM, patient-reported outcome measure; RDD, Regimen-related Diabetes Distress (a subscale of the DDS); SDSCA, Summary of Diabetes Self-Care Activities; SF-12, 12-Item Short-Form Survey; WBQ, Well-being Questionnaire; WHO-5, WHO Five-item Well-Being Index.