Liu 2012.
Methods |
Study design: RCT Unit of randomisation: patient Unit of analysis: patient Funding sources: Initiative for Cardiovascular Health Research in Developing Countries Conflicting interests: none declared |
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Participants |
Country: China Setting: Primary care Conditions/numbers: 208 diabetes patients (type 2) (intervention 119, control 89) Multi‐morbidity: n/a Health literacy: n/a, 2 rural communities. |
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Interventions |
Theoretical Framework: Chronic Disease Self‐Management Program (CDSMP) Focus: patient Type of intervention: Group visit + face‐to‐face consultation Clinicians involved: Nurse (usual), GP (usual), preventive doctor (usual) Tools: Participants were invited to attend a 12‐session (monthly) group visit programme + 60‐minute one‐to‐one visit with healthcare provider at the end of each group visit, if wanted (only ¼ received these). Programme followed Chronic Disease Self‐Management Programme (CDSMP) format, including setting goals and making action plans. The format was adapted from the Chinese version of Stanford CDSMP Leaders Manual. The content included topics covered in the generic CDSMP course as well as diabetes specific self‐management support topics recommended by Shanghai community diabetes prevention and control guidelines. Groups were led by existing general practice teams consisting of 1 GP, 1 preventive doctor, 1 nurse practitioner and 1 patient. Sessions focused on helping participants build confidence in their ability to deal with diabetes by incorporating self‐efficacy‐enhancing strategies, including action‐planning and feedback, modelling of behaviours by participants for one another, reinterpretation of symptoms, practicing self‐management skills, and group problem‐solving. Participants made 12 1‐week action plans over the 12 months. Each group also had a lay leader with diabetes who followed up with group members on their action plans in person or by telephone within 1 week. Staff attended a 1‐day training workshop. Stages completed: Limited ‐ B, C, F Usual provider aware of patient's goals and action plans: Yes Standardisation of clinician input: GPs and nurses involved in design of scripted programme implemented in 2 rural communities by 3 general practice teams + 1‐day training workshop Fidelity: 75.6% of participants attended 10 or more sessions. Patients who participated were significantly older with a higher prevalence of hypertension than those who declined Attrition: 15% lost to follow‐up Comparison: Usual care provided by a single GP |
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Outcomes |
Health status:physical: body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP); subjective: Self‐rated health, energy, health distress, fatigue, illness intrusiveness, depression (Chinese adaptations of Stanford instruments) Self‐management capabilities: self efficacy, symptom management (Stanford) Health behaviours: exercise (NV), diet (NV) Achievement of personal goals: n/a Service use: n/a Adverse events: none reported Length of follow‐up: baseline, 12 months |
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Notes | No primary outcome. No power calculation reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was by means of a random number table with a ratio designed to yield no fewer than 20 and no more than 25 participants in a group. (p. 5). |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of their assignments. Both participants and personnel were aware of treatment status and a number of outcomes were subjective. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collection was completed by university students who did not know the participants or their allocation status. All those assessing and analysing the data were blinded to group assignments (p. 5). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 98 out of 119 in the intervention group completed the 12‐month follow‐up and 78 out of 89 in the control group. Reasons for loss to follow‐up are documented in the flow diagram (p. 4) |
Selective reporting (reporting bias) | Unclear risk | No published protocol, but results presented for all listed outcome measures. |
Other bias | Unclear risk | No significant differences at baseline apart from prevalence of hypertension which was higher in the intervention group and fatigue and illness intrusiveness which were lower in the intervention group. |