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Not Yet Recruiting NCT07787884

Development and Pilot Application of a Solution-Focused Intervention for Social Isolation in Elderly Diabetic Foot Patients

Conditions: Diabetic Foot Disease

Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Anhui Medical University

Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui

Summary

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)

Eligibility Criteria

Inclusion Criteria: * (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.

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Source: ClinicalTrials.gov (NCT07787884). StuddyBuddy aggregates publicly available trial information.