Prevention and Management of Diabetes-Related Foot Ulcers through Informal Caregiver Involvement: A Systematic Review

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), ( value)
			Liang et al. (2012), China [42]	RCT; I30; C29			Mean age not stated; Female	(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 (% ) = vs. , (); (ii) More lower limb amputations were recorded in the control group; (iii) diabetes knowledge improved significantly () = vs 6 ().; (iv) Improved foot care behavior () = vs. ()
Subrata et al. (2020), Indonesia [44]	RCT; I27; C29	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: , , , (values for I vs C not stated); (ii) Clinical and statistical improvement in wound size, mm^2:, , , (values for vs. not stated)
McEwen (2017), USA [39]	RCT; I83; C74	Mean age; Female	(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 () = vs. ()
Maslakpak (2017), Iran [46]	RCT; I60; C30	Mean age not stated; Female	(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 () =5 vs , (; (ii) Improved HbA1c (%) = vs ()
Keogh et al. (2011), Ireland [47]	RCT; I60; C61	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 (% ) = vs. (); (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	Mean age not stated; Female	(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 (% ) = vs (); (ii) reported clinically significant improvement in wound size = vs ()
Hu et al. (2014), USA [41]	Prepost; I36; C-	Mean age; Female	(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 ,; (ii) Improved foot self-care behavior: Slope (95% CI), value = 0.242 (0.125 to 0.358),; (iii) Significantly improved diabetes knowledge: slope (95% CI), P value =0.501 (0.389 to 0.614),
Williams et al. (2014), USA [40]	Prepost; I25; C-	Mean age not sated; Female	(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 (% ) =7.40 (1.32),; (ii) Significantly improved foot care behavior (): , (); (i) Significantly improved diabetes knowledge (): , ()
Li et al. (2019), China [43]	Prepost; I80; C-	Female	(i) Foot self-care education using WeChat videos and telephone calls		Until discharge	(i) Significantly improved foot self-care behavior ()
Viswanathan et al. (2005), India [48]	Prepost; I4872; C-	Female	(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 (); (ii) Wound healing improved significantly = vs. (); (iii) Surgical interventions reduced significantly (3) vs. 75 (14), ()

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.