An interventional study of Intervention Group in Diabetic Foot Disease, sponsored by Anhui Medical University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Supportive care
The goal of this interventional study is to develop and preliminarily evaluate a solution-focused model-based intervention program for reducing social isolation in elderly patients with diabetic foot ulcers. It will also learn about the feasibility and safety of the intervention program. The main questions it aims to answer are:
Does the solution-focused intervention program effectively reduce social isolation levels in elderly patients with diabetic foot ulcers?
What effects does the intervention have on patients' foot self-care behaviors, social participation, social support, depressive symptoms, and glycemic control?
Researchers will compare an intervention group (receiving the solution-focused intervention combined with routine nursing care) to a control group (receiving routine nursing care only) to see if the intervention program works to alleviate social isolation in this population.
Participants will:
Complete a set of validated questionnaires (including assessments of social isolation, foot self-care behaviors, social support, social participation, and depressive symptoms) and undergo fasting blood glucose measurement at four time points: baseline, after 3 intervention sessions, at intervention completion, and 1-month post-intervention
Attend 5 weekly sessions (0.5 -1 hours each) of the solution-focused intervention program, which follows five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation (intervention group only)
Receive routine nursing care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions (both groups)
(1) Meet the current Chinese criteria for older adults, aged ≥60 years;
(2) Clinically diagnosed with diabetic foot (DF);
(3) Voluntarily agree to participate in this study after being informed of the study purpose by the researcher.
Exclusion Criteria:
(1) Severe cognitive impairment or mental disorders: patients definitively diagnosed with Parkinson's disease, senile dementia, or severe depression by a Class II-A or higher hospital; or those with a score below 9 on the Mini-Mental State Examination (MMSE) indicating severe cognitive impairment;
(2) Severe communication impairment: patients unable to communicate normally with others due to hearing impairment, speech impairment, or other related conditions;
(3) Patients unable to complete the questionnaire survey for any reason;
(4) Patients currently participating in other trials that may affect the results of this study.
Other: Intervention Group
Researchers will compare an intervention group (receiving the solution-focused intervention plus routine care) to a control group (receiving routine care only). Participants will complete validated questionnaires (LSNS-6, NAFF, SSRS, IPA, CES-D-10) and undergo fasting blood glucose measurement at four time points: baseline, after 3 sessions, at intervention completion, and 1-month post-intervention. The intervention group will attend 5 weekly sessions (1-1.5 hours each) following five core steps: problem description, goal setting, exception exploration, feedback, and progress evaluation. Both groups receive routine care including blood glucose monitoring, dietary management, medication guidance, psychological support, and activity instructions.
Level of Social Isolation
Measured by the Lubben Social Network Scale-6 (LSNS-6) , an abbreviated version of the original Lubben Social Network Scale developed by Lubben et al. The LSNS-6 assesses social network status from two dimensions: family network (3 items) and friend network (3 items), totaling 6 items. Each item is rated on a 6-point Likert scale (0 = none, 1 = one, 2 = two, 3 = three to four, 4 = five to eight, 5 = nine or more). Total scores range from 0 to 30. A total score \<12 indicates social isolation. Family network score \<6 indicates family network isolation, and friend network score \<6 indicates friend network isolation. The Chinese version has demonstrated adequate internal consistency with a Cronbach's α of 0.832.
Time frame: From enrollment to the end of treatment at 5 weeks
Social support level
Social support level measured by the Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS-SSS contains 19 items across four dimensions: emotional/informational support (8 items), tangible support (4 items), affectionate support (3 items), and positive social interaction (4 items). Each item is rated on a 5-point Likert scale (1=none of the time, 5=all of the time). Total scores are transformed to a 0-100 scale, with higher scores indicating better social support. The Chinese version has demonstrated good reliability and validity, with a Cronbach's α of 0.91.
Time frame: From enrollment to the end of treatment at 5 weeks.
Social participation level
Social participation level measured by the Social Participation Scale. This scale assesses the frequency and diversity of social activities across multiple domains, including family interactions, community activities, and social gatherings. Each item is rated on a 5-point Likert scale (1=never, 5=very often). Higher total scores indicate a higher level of social participation. The scale has been validated in older adult populations with chronic diseases, demonstrating satisfactory psychometric properties with a Cronbach's α of 0.85.
Time frame: From enrollment to the end of treatment at 5 weeks.
Depressive symptoms
Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items corresponding to the DSM-IV diagnostic criteria for major depressive disorder. Each item is rated on a 4-point Likert scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day) based on symptom frequency over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (0-5 minimal, 6-10 mild, 11-15 moderate, 16-20 moderately severe, 21-27 severe). Cronbach's α=0.89.
Time frame: From enrollment to the end of treatment at 5 weeks.
Glycemic control (fasting blood glucose)
Glycemic control measured by fasting blood glucose (FBG) in millimoles per liter (mmol/L). Venous blood samples are collected after an 8-hour overnight fast and analyzed using the standardized glucose oxidase method. Lower FBG values indicate better glycemic control. According to the Chinese Diabetes Society guidelines, normal FBG is 3.9-6.1 mmol/L. This objective biomarker provides a reliable assessment of short-term glycemic status.
Time frame: From enrollment to the end of treatment at 5 weeks.
Diabetic foot self-care behaviors
Diabetic foot self-care behaviors measured by the Diabetic Foot Self-Care Behavior Scale. This scale evaluates patients' adherence to recommended foot care practices, including daily foot inspection, proper washing and drying, moisturizing, nail care, appropriate footwear selection, and avoiding barefoot walking. Items are rated on a 5-point Likert scale (1=never, 5=always). Higher total scores indicate better adherence to diabetic foot self-care behaviors. The scale has shown good reliability with a Cronbach's α of 0.88.
Time frame: From enrollment to the end of treatment at 5 weeks.
Plan to share: No
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Anhui Medical University