Patja 2012.
| Study characteristics | ||
| Methods |
Health coaching by telephony to support self‐care in chronic diseases: clinical outcomes from the TERVA randomized controlled trial Patient RCT (7 providers), conducted with patients identified from primary care and hospital registries in the Paijat Hame region in Southern Finland, Finland Two arms: 1. Control (control arm) and 2. Intervention (intervention arm) |
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| Participants | Control arm N: 501 Intervention arm N: 1034 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1a) Controlled hypertension (DBP < 85 mmHg), N under control (%) Control arm: pre NR (NR), post 49 (38) Intervention arm: pre NR (NR), post 120 (45) 1b) Controlled hypertension (SBP < 140 mmHg), N under control (%) Control arm: pre NR (NR), post 53 (36) Intervention arm: pre NR (NR), post 107 (33) |
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| Funding source | Joint Authority for Päijät‐Häme Social and Health Care Sitra ‐ the Finnish Innovation Fund TEKES ‐ the Finnish Funding Agency for Technology and Innovation Pfizer Oy | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers. |
| Allocation concealment (selection bias) | Low risk | Cluster. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | ~19% lost to follow‐up in N1, ~21% lost in N2, some provided reasons, but also grouped no information available. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objective laboratory methods to measure primary outcome of SBP/DBP not reported. |
| Selective reporting (reporting bias) | High risk | Secondary outcomes do not match protocol and vice versa. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Unclear risk | Measurement bias (information bias). |