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

NCT07787884 | Not Yet Recruiting

• 1 other identifier: 81250948
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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.

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

OTHER

Other: Intervention Group

Interventions

Intervention Group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230031, China

Location

Central Study Contacts

Junnan Song

CONTACT

+86 18712096043; junnansong00@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: August 27, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)