The effect of an intensive patients' education program on anxiety, depression and patient global assessment in diabetic foot ulcer patients with Wagner grade 1/2: A randomized, controlled study

Abstract

This study aimed to synthetically evaluate the impact of intensive patients' education program (IEP) on anxiety, depression and patient global assessment (PGA) in diabetic foot ulcer (DFU) patients.One hundred eighty DFU patients with Wagner grade 1 and Wagner grade 2 were consecutively recruited in this randomized, controlled study and randomly assigned to IEP group (N = 90) or control group (N = 90) as 1:1 ratio. In the IEP group, patients received the IEP and usual care, and patients in the control group received usual care only. IEP included educating patients and their family members, supervising patients' harmful habits and diets, psychological care for the patients and establishing a patient-physician-nurse WeChat group. Hospital Anxiety and Depression Scale-anxiety/depression (HADS-A/D) and Zung Self-Rating Anxiety/depression Scale (SAS/SDS) were applied to assess anxiety/depression at M0-M3. PGA score was also assessed at M0-M3.For anxiety assessment, IEP group presented decreased HADS-A/SAS scores at M2/M3 and increased HADS-A/SAS score changes (M3-M0) compared to control group. For depression assessment, IEP group displayed reduced HADS-D/SDS scores at M2/M3 and raised SDS score change (M3-M0) compared to control group. Moreover, IEP group exhibited reduced PGA score at M1/M2/M3 and elevated PGA score change (M3-M0) compared to control group. Further subgroup analyses disclosed that IEP reduced HADS-A/SAS/HADS-D/PGA scores at M3 and elevated these score changes (M3-M0) in patients with Wagener grade 2 but not Wagener grade 1.IEP ameliorates anxiety, depression and PGA in DFU patients with Wagner grade 2 but not Wagner grade 1.

Figure 1

Flow chart.

Figure 2

Anxiety score, score change (M3-M0), anxiety rate and severity assessed by HADS and SAS in DFU patients. For anxiety assessed by HADS, lower anxiety score at M3 (A) and no difference of anxiety change (B), rate (C) as well as severity (D) were observed in IEP group compared to control group. For anxiety evaluated by SAS, reduced anxiety score at M2/M3 (E) and no difference of anxiety change (F), rate (G) as well as severity (H) were discovered in IEP group compared to control group. Comparison was determined by t test, Chi-square test or Wilcoxon rank sum test. ∗∗ = P < .01. M (month), ∗ = P < .05, DFU = diabetic foot ulcer, HADS = Hospital Anxiety and Depression Scale, IEP = intensive patients’ education program, NS = not significant, SAS = Zung Self-Rating Anxiety Scale.

Figure 3

Depression score, score change (M3-M0), depression rate and severity assessed by HADS and SDS in DFU patients. For depression assessed by HADS, decreased depression score at M3 (A) and no difference of depression change (B), rate (C) as well as severity (D) were uncovered in IEP group compared to control group. For depression evaluated by SDS, lower depression score at M2/M3 (E) and no difference of depression change (F), rate (G) as well as severity (H) were shown in IEP group compared to control group. Comparison was determined by t test, Chi-square test or Wilcoxon rank sum test. ∗ = P < .05. M (month), DFU = diabetic foot ulcer, HADS = Hospital Anxiety and Depression Scale, IEP = intensive patients’ education program, NS = not significant, SDS = Zung Self-Rating Depression Scale.

Figure 4

PGA score and PGA score change (M3-M0) in DFU patients. Compared to control group, lower PGA scores at M1/M2/M3 were observed in IEP group (A), while there was no difference of PGA score change (M3-M0) between two groups (B). Comparison was determined by t test. ∗∗ = P < .01. M (month), ∗ = P < .05, DFU = diabetic foot ulcer, IEP = intensive patients’ education program, NS = not significant, PGA = patient global assessment.

Figure 5

Anxiety, depression and PGA in DFU patients with Wagner I. For anxiety, no difference of HADS-A (A) and SAS (B) scores at M3, or score change (M3-M0) was discovered between IEP group and control group. For depression, no difference of HADS-D(C) and SDS (D) scores at M3, or score change (M3-M0) was shown between 2 groups. Additionally, there was no difference of PGA score (E) at M3 or score change (M3-M0) between 2 groups. Comparison was determined by t test. DFU = diabetic foot ulcer, HADS-A/D = Hospital Anxiety and Depression Scale-Anxiety/Depression, IEP = intensive patients’ education program, PGA = patient global assessment, SAS = Zung Self-Rating Anxiety Scale, SDS = Zung Self-Rating Depression Scale.

Figure 6

Anxiety, depression and PGA in DFU patients with Wagner II. For anxiety, lower HADS-A (A) and SAS (B) scores at M3 as well as higher both scores change (M3-M0) were observed in IEP group compared to control group. For depression, decreased HADS-D (C) score at M3 and increased both scores change (M3-M0) (C, D) were discovered in IEP group compared to control group. Moreover, there were reduced PGA score at M3 and elevated score change (M3-M0) (E) in IEP group compared to control group. Comparison was determined by t test. DFU = diabetic foot ulcer, HADS-A/D = Hospital Anxiety and Depression Scale-Anxiety/Depression, IEP = Intensive patients’ education program, PGA = patient global assessment, SAS = Zung Self-Rating Anxiety Scale, SDS = Zung Self-Rating Depression Scale.