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Construction and Preliminary Application of a Solution-Focused Model-Based Intervention Program for Social Isolation in Elderly Patients With Diabetic Foot Ulcers
Sponsor study identifier
interventional
70
1 country
1
Study Start
August 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 20, 2026
Actual (reported)August 26, 2026
Actual (reported)August 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
From enrollment to the end of treatment at 5 weeks
Social support level
From enrollment to the end of treatment at 5 weeks.
Social participation level
From enrollment to the end of treatment at 5 weeks.
Depressive symptoms
From enrollment to the end of treatment at 5 weeks.
Glycemic control (fasting blood glucose)
From enrollment to the end of treatment at 5 weeks.
Diabetic foot self-care behaviors
From enrollment to the end of treatment at 5 weeks.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031, China
First Submitted
August 20, 2026
First Posted
August 26, 2026
Study Start
August 27, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
October 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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