Glasgow 2002.
| Study characteristics | ||
| Methods |
Implementation, generalization and long‐term results of the "choosing well" diabetes self‐management intervention RCT (NA clusters and NA providers), conducted in 1) Outpatients of primary care physicians at 12 medical offices. These offices were located in one of 6 small‐ to moderate‐sized communities within 30 miles of Eugene, Oregon, USA. The first session was held at the Center for Healthy Living, a centralised location for most participants. 2) Intervention delivered by health counsellors and 4 interventionists (a nurse/certified diabetes educator, a registered dietitian, a doctoral level psychologist and an education major). In United States of America. 4 arms: 1. Control (basic goal setting condition) (control arm) and 2. Intervention 1 (basic and community resources condition) (intervention arm), 3. Intervention 2 (basic and telephone follow‐up condition) (other arm), 4. Intervention 3 (combined condition: telephone and community resources) (other arm) |
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| Participants | Control arm N: 80 Intervention arm N: 80, 80, 80 Diabetes type: 2 Mean age: 59.375 ± 10.14 % Male: 43.25 Longest follow‐up: 12 months |
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| Interventions |
Control arm: (basic goal‐setting condition) 1) Facilitated relay of clinical information 2) Patient education 3) Promotion of self‐management Intervention arm: (basic and community resources condition) 1) Facilitated relay of clinical information 2) Patient education 3) Promotion of self‐management Intervention arm: (basic and telephone follow‐up condition) 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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| Outcomes | Glycated haemoglobin | |
| Funding source | This study was supported by Grant R01‐35524 from the National Institute of Diabetes Digestive and Kidney Diseases | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. 320 participants were randomised within providers to eliminate confounding of intervention and provider effects. The number of patients randomised per provider ranged from 1 to 29 with a median of 4. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Table 1. All P values above 0.05. As can be seen in Table 1, there were no differences between conditions on any of the demographic or medical characteristic variables collected. |
| Patient's baseline outcomes (selection bias) | Unclear risk | No P values reported for HbA1c between arms at baseline (Table 2). HbA1c data are not included in Table 1 (baseline characteristics by treatment conditions). |
| Incomplete outcome data (attrition bias) | High risk | One‐year follow‐up data were collected on 89% of the randomised participants (range of 84% to 93% among conditions, NS). According to the range, they lost 7% in one group and 16% in another one. Unbalanced lost between groups. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcome (HbA1c). |
| Selective reporting (reporting bias) | Unclear risk | No registered protocol, but we found a previous study (reference 10) with more details about protocol. Results match protocol. |
| Risk of contamination (other bias) | Unclear risk | 320 participants were randomised within providers (same professionals had patients in different arms) to eliminate confounding of intervention and provider effects. However, a parallel form containing the participant’s lab results was sent to each primary care provider, which may have led them to change their clinical care to patients. |
| Other bias | Low risk | None. |