1. Introduction
2. Methods
2.1. Research Objective
2.2. Study Design and Registration
2.3. Eligibility Criteria
2.4. Information Sources
2.5. Search Strategy
2.6. Study Records
2.6.1. Data Collection Process
2.6.2. Critical Appraisal
2.6.3. Data Synthesis
3. Results
3.1. Search Outcomes
3.2. Critical Appraisal
| No. | Study (Author, Year) | Random Sequence Generation | Allocation Concealment | Blinding of Participants and Personnel | Blinding of Outcome Assessment | Incomplete Outcome data | Selective Reporting | Other Bias | Overall Judgement |
|---|---|---|---|---|---|---|---|---|---|
| 1 | Waki K et al., 2024 (20) | Low | Low | Low | Low | Low | Low | Low | Low |
| 2 | Kazawa et al., 2020 (28) | Unclear | Unclear | Unclear | Low | Low | Low | High | High |
a Low indicates low risk of bias across domains. Unclear indicates insufficient methodological information reported in the original study. High indicates high risk of bias in at least one domain.
| No. | Study (Author, Year) | Bias due to Confounding | Bias in Selection of Participants into the Study | Bias in Classification of Interventions | Bias due to Deviations from Intended interventions | Bias due to Missing data | Bias in Measurement of the Outcome | Bias in Selection of the Reported result | Overall Judgement |
|---|---|---|---|---|---|---|---|---|---|
| 3 | Helou et al., 2020 (16) | Low | Low | Low | Low | Low | Low | Low | Low |
| 4 | Kazawa and Moriyama, 2013 (23) | NI | Low | NI | Low | Low | NI | Low | Moderate |
| 5 | Pagels et al., 2015 (17) | Moderate | Low | Moderate | NI | Low | Low | Low | Moderate |
| 6 | Thojampa, 2017 (24) | NI | Low | Low | Low | Low | Moderate | Low | Moderate |
| 7 | Hui et al., 2018 (25) | Low | Low | Moderate | NI | Low | Low | Low | Moderate |
| 8 | Limin et al., 2020 (19) | Low | Low | Low | Low | Low | Low | Low | Low |
| 9 | Qian and Lizhi, 2021 (29) | Low | Low | Low | NI | Low | Serious | Moderate | Serious |
| 10 | Qinghua et al., 2013 (26) | Low | Low | Low | NI | Low | Moderate | Moderate | Moderate |
| 11 | Wencui et al., 2021 (18) | Low | Low | Low | Low | Low | Low | Low | Low |
| 12 | Xiaojie and Binghui 2016 (27) | NI | Low | Low | NI | Low | NI | Low | Moderate |
a Low indicates low risk of bias across domains. Moderate indicates that the study provides sound evidence but is not comparable to a well-performed randomized trial. Serious indicates important methodological problems in one or more domains. NI, no information available for judgment according to the ROBINS-I tool.
3.3. Study Characteristics
| No. | Study (Author, Year) | Study Design | Participants | Sample Size | Intervention | Duration | Frequency | Format | Follow-up (Duration or Frequency) | Data Collection Timepoint | Outcomes Assessed | Significant Findings |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Waki K et al., 2024 (20) | RCT | T2DM with moderately increased albuminuria:30 - 299 mg/g | 126 | DialBetesPlus smartphone application | 18 months | Continuous | Remote monitoring | Y | Baseline, month 12,and month 18 | BMI, HbA1c, BP, UACR, eGFR, FBG, LDL-C, HDL-C, SDSCA, QOL. | UACR and HbA1c were significantly improved. |
| 2 | Helou et al., 2020 (16) | Crossover design | DKD, eGFR < 60 mL/min or ACR > 30 mg/mmol | 32 | Multidisciplinary Self- Management Support Program | 12 months | Every two weeks | Telephone contact | Y (3 months) | Baseline, and after each follow-up period of 3 months, totally 4 times | QOL, Self-care activities, HbA1c and Scr, UACR and eGFR | The intervention improved the QOL demonstrating higher mean rank as compared to usual care and three self-care activities, general diet habits, diabetes diet habits, and blood sugar testing. |
| 3 | Kazawa and Moriyama, 2013 (23) | A one group pre- and post-test design | DKD, eGFR between 15 to 59 mL/min/1.73m^2, UACR ≥ 300 mg/g Cr, and between 20 to 74 years of age. | 30 | Self-management skills-acquisition program | 6 months | The first to fourth sessions were every two weeks. The fifth and sixth sessions were once a month. | Face-to-face meetings, telephone or e-mail | Y (every month) | Baseline, three months and six months after intervention | Self-efficacy, QOL HbA1c, Scr, eGFR, BUN, HbA1c, TP, albumin, K, Pi, TG, LDL-c, and HDL-c, BP and BMI | 1.Self-efficacy and self-management behaviors improved due to educational intervention. 2.HbA1c levels were reduced after the intervention,no changes in renal function were observed. |
| 4 | Kazawa et al., 2020 (28) | RCT | T2DM and having a proteinuria of ≥ 2+ or a proteinuria of 1+ and HbA1c ≥ 7.0% (or FBS ≥ 130 mg/dL) and aged 40 years or older. | 40 | Telecommunication-device-based remote self-management education and intermittent telephone calls | 6 months | Once a month | Tablet computer | Y (Biweekly, total nine) | Baseline and six months | Self-management behaviors, Clinical indicators: eGFR, HbA1c, SBP, DBP, BMI, Psychological indicators: Self-Efficacy and QOL | 1.Both groups showed similar behavioral changes, and the participants verified the feasibility of the remote interviews. 2.The degree of behavioral change regarding self-monitoring was lower than that shown by the control group. |
| 5 | Pagels et al., 2015 (17) | Uncontrolled before and after | DKD and with eGFR ≥ 30 mL/min | 58 | A group-based, multidisciplinary and multidimensional support program | 6 months | Three consecutive days | Sessions | N | Baseline and post-intervention | HbA1c, blood lipids, UACR, eGFR, Weight, BMI, WC, BP, PA, Tobacco habits | HbA1c was significantly improved after intervention. There was no significant difference between baseline and follow-up in BP, BMI, WC, UACR or eGFR. |
| 6 | Thojampa, 2017 (24) | Quasi-experimental study | Diagnosed T2DM for at least five years and 20 years or older | 50 | Self-management support and family participation enhancing program | 12 weeks | weekly | Face-to-face sessions and group discussion | N | 1. Clinical outcome on week 1 and week 12.2. Psychology Measures on week 1, and week 8 and week 12 after intervention. | GFR, Creatinine, BP, HbA1c; Self-management activities, Self-efficacy. | Self-management support and family participation enhancing program improved self-management activities and self-efficacy, decreased HbA1c, Creatinine, SBP, DBP, increased eGFR. |
| 7 | Hui et al., 2018 (25) | Quasi-experimental study | DKD and UAER < 300 mg/24h | 92 | WeChat Health Education Based on the Information-Motivation-Behavior (IMB) Model | 6 months | Once a week | WeChat group | Y (6 months) | pre-intervention and 6-month post-intervention | Treatment Adherence Behavior,Self-Efficacy, QOL | The intervention can enhance patients' self-efficacy levels, improve treatment adherence, and enhance the overall quality of life. |
| 8 | Limin et al., 2020 (19) | Quasi-experimental study | Patients in stage III of DKD | 94 | Comprehensive nursing intervention, collaborative outpatient follow-up management by multidisciplinary medical and nursing staff | 1 year | Three times a week | Y (every three months) | Baseline and post-intervention | Adherence to treatment, Irritability, Depression, and Anxiety Scale, Control Rate of Early Risk Factors for DKD (BMI, HbA1c, BP, LDL-C, TG, UACR and GFR, QOL | Comprehensive nursing intervention can alleviate negative emotions in early-stage DKD patients. After intervention, the observation group achieved a better control rate of DKD risk factors and the improvement of the quality of life compared to the control group. | |
| 9 | Qian and Lizhi, 2021 (29) | Quasi-experimental study | DKD | 60 | Video education combined with feedback method | 2 weeks | Not clear | Video | N | Pre- and post- intervention | FBG, 2hPG, HbA1c, Psychological state, Self-management behavior | After intervention, patients in the observation group had lower anxiety and depression scores compared to the control group, the observation group exhibited significantly better blood glucose and higher score of self-management behavior compared to the control group. |
| 10 | Qinghua et al., 2013 (26) | Quasi-experimental study | DKD III stage | 110 | Continued self-management education | 18 months | Not clear | Sessions | Y (at the end of each month) | Urinary microalbumin is collected only at 12 months and 18 months. Other indicators are collected four times: upon admission, 6 months, 12 months and 18 months after discharge. | Diabetes risk factor control rate (FBG, 2hPG, BP, HbA1c, TG, TC, BW, UMA), Knowledge awareness and preventive behaviors related to the disease. | The continued self-management education contributes to improving patients' knowledge about the disease and enhances patients' ability to achieve the targeted control rates for DKD risk factors. |
| 11 | Wencui et al., 2021 (18) | Quasi-experimental study | DKD III stage and ≥ 60 years old | 60 | Multidisciplinary and staged management | 3 months | Five times per week | Session and WeChat public account | once every two weeks | Baseline and after the intervention | FBG, 2hPG, HbA1c,UACR, GFR; Self-management ability; Social support; Depression; QOL | After intervention, FBG, 2hPG, HbA1c, UACR, GFR and the scores of self-management ability, QOL and social support were significantly better, whereas the score of depression was significantly lower in the intervention group compared with the control group. |
| 12 | Xiaojie and Binghui, 2016 (27) | Quasi-experimental study | Early stage of DKD | 70 | Information-Motivation-Behavior Health education model | 6 months | Every 3 weeks | Lecture | N | Pre- and post-intervention | FBG, 2hPG, HbA1c, UACR; Diabetes related knowledge, Self-management behaviors | After the intervention, there were statistically significant differences observed in knowledge scores, self-management behavior scores, and DKD indicators between experimental group and control group. |
a Abbreviations: 2hPG, 2-hour postprandial glucose; BMI, body mass index; BP, blood pressure; BUN, blood urea nitrogen; BW, body weight; DBP, diastolic blood pressure; FBG, fasting blood glucose; GFR, glomerular filtration rate; HbA1c, glycated hemoglobin; HDL-C, high-density lipoprotein cholesterol; K, potassium; LDL-C, low-density lipoprotein cholesterol; PA, physical activity; Pi, inorganic phosphate; QOL, quality of life; SBP, systolic blood pressure; SDSCA, Summary of Diabetes Self-Care Activities; SCr, serum creatinine; TC, total cholesterol; TG, triglycerides; TP, total protein; UACR, urinary albumin-to-creatinine ratio; UMA, urinary microalbumin; Y, yes; N, no.
