Browning 2016.
Study characteristics | ||
Methods |
Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches Clustered RCT (41 clusters and NR providers), conducted in 1) Study held in a primary healthcare setting in Beijing, China. The context of the intervention site, namely Community Health Stations (CHSs) within a district of Beijing where preventive care, health management, primary medical care, rehabilitation, health education and family planning are offered. 2) Management intervention delivered by health coaches. Health coaching was performed by experienced clinicians (community doctors, nurses and psychologists) from each CHS. In China. 2 arms: 1) Control (usual care) (control arm) and 2) Intervention (coach‐led motivational interviewing) (intervention arm) |
|
Participants | Control arm N: 368 Intervention arm N: 385, NA, NA Diabetes type: 2 Mean age: 63.8 ± 6.24 % Male: 47.3 Longest follow‐up: 12 months |
|
Interventions |
Control arm: (usual care) Intervention arm: (coach‐led motivational interviewing) 1) Case management 2) Promotion of self‐management 3) Continuous quality improvement |
|
Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
|
Funding source | This trial was funded by the Fengtai Health Bureau, Beijing, China, and in‐kind support was provided by Monash University, Australia, and Peking University, China | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | CHSs were randomised into the control or intervention groups, using block randomisation. Participants were sampled by computerised random allocation software that stratified by gender in order to achieve balance. |
Allocation concealment (selection bias) | Low risk | Cluster‐randomised. In order to minimise selection bias, this process was carried out centrally by an independent person and all CHSs were coded to ensure the randomisation was a blinded process. |
Provider's baseline characteristics (selection bias) | Unclear risk | Of the 41 randomised Community Health Stations (CHSs, 21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. No CHSs characteristics are reported at baseline. |
Patient's baseline characteristics (selection bias) | Low risk | Table 3. Means are similar. The intervention and control groups were similar for all variables at baseline. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. Means appear similar between controls and interventions at baseline but no P value are reported and nothing is reported in the text about differences at baseline. "The intervention and control groups were similar for all variables at baseline, and even if statistical differences between groups were observed then the analysis method could have accounted for this by adjusting for baseline scores." |
Incomplete outcome data (attrition bias) | High risk | Only 295 out of 385 patients were analysed for the primary outcome at 12 months in the intervention group (23.4% lost) and 282 out of 368 in the control group (23.4%). Reasons not reported. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | All objective outcomes (HbA1c, SBP, DBP and LDL). |
Selective reporting (reporting bias) | Unclear risk | Prospectively registered protocol (protocol first posted in November 2010, study started in June 2011). In the protocol: Outcome measures will be assessed at 6, 12 and 18 months. In the paper: Outcomes were assessed at baseline, 6 and 12 months. They do not report data for homocysteine. |
Risk of contamination (other bias) | Unclear risk | Cluster‐RCT however, in order to complete the data collection requirements for the study, increased monitoring that deviated from usual care recommendations was necessary. Although glycaemic control did not differentially improve, HbA1c in both groups changed significantly and for the better, as did triglycerides, LDL cholesterol and HDL cholesterol. It can be assumed that this trial served as a catalyst for the revitalisation of primary care delivery to individuals with T2DM. Also, the study received a considerable amount of media attention throughout the intervention phase, which may have resulted in participants and CHS staff altering their usual behaviour. |
Other bias | Low risk | None. |