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

NCT07787884 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-26

No results posted yet for this 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)

Conditions

  • Diabetic Foot Disease

Interventions

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.

Sponsors & Collaborators

  • Anhui Medical University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-27
Primary Completion
2026-10-30
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787884 on ClinicalTrials.gov