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Starting soon Not applicable

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

NCT07787884 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-08-27
Last updated
2026-08-26

Condition(s) studied

Diabetic Foot Disease

Investigational drug(s) / intervention(s)

Intervention Group

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.

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Level of Social Isolation — From enrollment to the end of treatment at 5 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07787884 on ClinicalTrials.gov ↗ ← All trials in China