Table 2.
Characteristics of studies.
| Study ID & country | Study design; participants (I;C) | Participant characteristics | Intervention and control treatment | Intervention duration/follow up | Outcomes (I vs. C), (P value) | |
|---|---|---|---|---|---|---|
| I | C | |||||
| Liang et al. (2012), China [42] | RCT; I30; C29 |
N = 59 Mean age not stated Female n = 26 |
(i) Skills training and education on foot care through group diabetes classes, and provision of foot care kits. (ii) Delivered through hands-on workshops and telephone calls |
Routine diabetes care and treatment which consisted of unstructured diabetes education | 3 months 24 months |
(i) HbA1c improved significantly (% mean ± SD) =6.5 ± 2.3 vs. 7.9 ± 4.2, (P = ˂0.01) (ii) More lower limb amputations were recorded in the control group; LLA (%) = 6.90 vs.0.00, (P = 0.4569) (iii) diabetes knowledge improved significantly (mean ± SD) =89.56 ± 7.00 vs 67.87 ± 5.26 (P˂0.01). (iv) Improved foot care behavior (mean ± SD) =87.24 ± 6.20 vs. 71.43 ± 5.17 (˂0.01) |
| Subrata et al. (2020), Indonesia [44] | RCT; I27; C29 |
N = 56 Mean age not stated Female n =20 |
(i) Self and family management support program. (ii) Delivered through skills training on wound care and motivational interviewing. |
Routine diabetes care and unstructured education | 3 months 3 months |
(i) Improved HbA1c: MS = 10.92, df = 1, F = 6.65, P = 0.013 (values for I vs C not stated) (ii) Clinical and statistical improvement in wound size, mm2:MS = 21799.41, df = 1, F = 38.11, P = 0.000 (values for I vs. R not stated) |
| McEwen (2017), USA [39] | RCT; I83; C74 |
N = 157 Mean age 53.53 ± 9.0 Female n = 102 |
(i) Family-based self-management social support intervention, providing information on diabetes and complication prevention. (ii) Involved discussions to set diabetes management goals |
Wait-list control | 3 months 6 months |
(i) Improved foot care behavior (mean ± SD) =5.91 ± 1.5 vs. 5.20 ± 2.0 (P = .50) |
| Maslakpak (2017), Iran [46] | RCT; I60; C30 |
N = 90 Mean age not stated Female n = 39 |
(i) Family-oriented empowerment diabetes education using face-to-face or telephone call. (ii) It involved collaborative problem solving and discussion with patients |
Usual unstructured education and pamphlet | 3 months 3 months |
(i) Foot care behavior improved significantly for the intervention group (means ± SD) =28.99 ± 5.55 vs 11.23 ± 8.57, (P = 0.0001 (ii) Improved HbA1c (%) =1.2 ± 7.19 vs 1.5 ± 7.8 (P = 0.21) |
| Keogh et al. (2011), Ireland [47] | RCT; I60; C61 |
N = 121 Mean age not stated Female not stated |
Individually tailored family education to address negative perceptions about diabetes using motivational interviewing techniques | Routine diabetes care without home visits | 3 weeks 6 months |
(i) Improved HbA1c (% mean ± SD) =8.41 ± 0.99 vs. 8.80 ± 1.36 (P = 0.04) (ii) Foot care behavior—reported there was no significant difference between groups, but no values provided |
| Appil et al. (2019), Indonesia [45] | Non-RCT; I17; C16 |
N = 33 Mean age not stated Female n = 19 |
(i) Family empowerment educational program to provide basic information on diabetes and foot ulcer care. (ii) Delivered though diabetes lectures and discussions |
Nonstructural education from nurses | 4 weeks 12 weeks |
(i) Improved HbA1c (% mean ± SD) =8.81 ± 1.83 vs 10.40 ± 2.56 (P = .48) (ii) reported clinically significant improvement in wound size =4.71 ± 7.77 vs (P = .10) |
| Hu et al. (2014), USA [41] | Prepost; I36; C- |
N = 36 Mean age 50 ± 11 Female n = 27 |
(ii) Family-based cultural intervention through group and family sessions to provide information on diabetes self-management (iii) It involved the use of picture illustrations, videotape stories and seminar discussions |
10 weeks 4 weeks |
(i) Improved HbA1c: Slope (95%CI) = −0.028 (−0.059 to 0.002), P = .0683 (ii) Improved foot self-care behavior: Slope (95% CI), P value = 0.242 (0.125 to 0.358), P = .0002 (iii) Significantly improved diabetes knowledge: slope (95% CI), P value =0.501 (0.389 to 0.614), P˂.0001 |
|
| Williams et al. (2014), USA [40] | Prepost; I25; C- |
N = 25 Mean age not sated Female n = 20 |
(i) Community group diabetes self-management education (DSME) based on the ADA self-care behavior (ii) This program used videotaped stories; assisting to set (i) This program used videotaped stories; assisting to set individual diabetes management goals and group discussions. |
8 weeks 24 months |
(i) Improved HbA1c (% mean ± SD) =7.40 (1.32), P = .26 (ii) Significantly improved foot care behavior (mean ± SD): 5.76 ± 1.76, (P = 0.001) (i) Significantly improved diabetes knowledge (mean ± SD): 76 ± 0.14, (P = 0.001) |
|
| Li et al. (2019), China [43] | Prepost; I80; C- |
N = 80 Mean age = 64.91 ± 11.68 Female n = 42 |
(i) Foot self-care education using WeChat videos and telephone calls | Until discharge | (i) Significantly improved foot self-care behavior (mean ± SD) = 75.85 ± 5.04 (P = 0.000) | |
| Viswanathan et al. (2005), India [48] | Prepost; I4872; C- |
N = 4872 Mean age = 60.5 ± 8.8 Female n = 1450 |
(i) Intensive treatment of foot problems, support and education on foot care and foot checks. (ii) The intervention also involved the use of pictures of foot ulcers; provision of customized orthoses for patients and assisting patients to select appropriate footwears |
Not stated 18 months |
(i) HbA1c improved significantly at follow up (%mean ± SD) = 9.2 ± 2.1 vs 10.3 ± 3.3 (P˂0.0001) (ii) Wound healing improved significantly =48 ± 18 vs. 90 ± 27 (P = 0.0001) (iii) Surgical interventions reduced significantly n(%) = 23 (3) vs. 75 (14), (P = 0.0001) |
|
I: intervention group; C: controlled group; SD: standard deviation; RCT: randomized controlled trial; non-RCT: nonrandomized controlled trial; LLA: lower limb amputation; PEDIS: Perfusion, Extent, Depth, Infection and Sensation; MS: mean square between subjects; %: percentage; HbA1c: glycated hemoglobin; vs.: versus; DSME: diabetes self-management education; ADA: American Diabetes Association.