Jiang 2021.
| Study characteristics | |
| Methods |
Study design: RCT Duration of study: the study was conducted from April 2017 to December 2018 (then 12‐month follow‐up). Country: China Income classification: upper‐middle income country in 2017‐2018 Geographical scope: mainland China Healthcare setting: four hospitals in mainland China with levels not above grade III‐B |
| Participants | 1. Age: mean age 56.91 (SD 10.05) years; for intervention group 57.35 (SD 9.09) years and for control group 56.46 (SD 10.95) years 2. Gender: both 3. Socioeconomic background: individual monthly income < 2000 RMB ($296.09) in 53.21% of patients (54.89% [intervention group] and 51.52% [control group]) 4. Educational background: 43.40% only primary school or below; more or equal to junior high school in 57.89% (intervention group) and 55.30% (control group) Inclusion criteria Patients were recruited if they were: a. diagnosed with T2DM; b. aged between 18 and 75 years; c. had their HbA1c in the past 12 weeks no less than 7.5%; d. not on insulin in the past 3 months. Exclusion criteria: a. patients being pregnant or preparing for pregnancy; b. with psychological problems or cognition disorders; c. developing severe diabetes complications; d. participating in other research projects Note: at baseline, the intervention and control group scores for the Diabetes Distress Scale (DDS) were, respectively, 2.43 and 2.33. Stated purpose: to assess the benefits of SSEP amongst type 2 diabetes mellitus patients not on insulin at a 12‐month follow‐up |
| Interventions |
Name: Self‐efficacy‐focused Structured Education Program (SSEP) Title/name of PW and number: trained registered nurses and physicians; 20 in total (3 physicians and 2 nurses in each research centre) 1. Selection: not specified 2. Educational background: physicians and nurses 3. Training: all the research staff received the training before research began (details in Jiang 2019); they received research guidelines about the study functions and responsibilities from the central researchers. 4. Supervision: monitoring every 3 months by the central researchers 5. Incentives/remuneration: not specified Prevention type: indicated – participants presented with some level of distress as indicated by the DDS scores, but all those with psychological problems were excluded. Intervention details: the programme consisted of four structured curriculums and regular follow‐up. It was delivered in a group format (with 4 to 8 patients in the respective group), once per week and continued for 4 weeks. The programme aimed to promote patients recruited in the learning, motivate patients to change, and develop and sustain self‐management behaviours by primarily stressing the enhancement of patients’ self‐efficacy. Control: usual care (individual face‐to‐face diabetes education presented by physicians during each medical clinic visit, as well as the conventional class education delivered by physicians and nurses per month). In addition, the follow‐up/3 months was offered by nurses via face‐to‐face/telephone). |
| Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (1‐6 months, 7‐24 months) |
| Notes |
Source of funding: Hainan Provincial Natural Science Foundation of China (820RC631, 819QN229), Young Talents’ Science and Technology Innovation Project of Hainan Association for Science and Technology (QCXM202019), the Project of Science Research Project in Hainan University of Higher Education (Hnky2020‐36), and Hainan Health Commission Health Industry Research Project (20A200286) Notes on validation of instruments (screening and outcomes): the internal consistency, reliability and criterion validity of C‐DDS were established (Li 2012). Cronbach’s α was 0.952 in this study. Additional information: none Handling the data: not applicable Prospective trial registration number: ChiCTR‐IOR‐17011007 |