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RecruitingNCT07881588Updated Oct 19, 2026

Construction and Empirical Research of a Risk Prediction Model for Preventing Lower Extremity Arteriosclerosis Obliterans in Diabetic Patients Based on the HAPA Model

An interventional study of Routine Care and Experimental group intervention in Diabetes Mellitus and Peripheral Arterial Disease, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

In this study, Logistic regression analysis was used to construct a risk prediction model for ASO in diabetic patients. Guided by the HAPA model, a nursing intervention plan for preventing ASO in diabetic patients was constructed and verified, with the aim of reducing the occurrence of ASO in diabetic patients and providing a reference for improving the quality of life of diabetic patients in clinical practice

02

Conditions studied

  • Diabetes Mellitus
  • Peripheral Arterial Disease
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 154 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Second Affiliated Hospital of Nanchang University is the lead sponsor of 81 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meet the clinical diagnostic criteria for type 2 diabetes;
  • Age ≥18 years old;
  • The patient is conscious, has no language communication barriers, and has certain reading and writing abilities.
  • The patient or caregiver can use smart devices.
  • Informed consent and voluntary participation.

Exclusion criteria

Exclusion Criteria:

  • Those with severe audio-visual or cognitive impairments;
  • Combined with other serious physical diseases, such as malignant tumors, etc.
  • Have a history of mental illness;
  • Patients who already have lower extremity arterial disease.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
154 participants (estimated)

Study arms

  • Active comparator
    control group

    The control group received routine care, namely admission education, routine care and education during hospitalization, unified health education at discharge, and routine follow-up after discharge.

    Other: Routine Care

  • Experimental
    Experimental group

    Based on the control group, the experimental group implemented the ASO prevention and nursing intervention program for diabetic patients based on the risk prediction model and the HAPA model

    Behavioral: Experimental group intervention

Interventions

  • OtherRoutine Care

    Upon admission, the researcher and responsible nurse jointly assess the patient's condition, help the patient relax, introduce the hospital environment, ward routines, and relevant regulations, and the researcher guides the patient to complete the general information questionnaire. During hospitalization, the researcher first explains the causes and influencing factors of diabetes in a demonstration classroom, emphasizes healthy lifestyle habits, and advises smoking cessation and alcohol limitation. Next, dietary and exercise guidance is provided to both patients and their families. Finally, instruction is given on blood sugar monitoring and the importance of taking medication as prescribed.

  • BehavioralExperimental group intervention

    Based on the control group, the experimental group implemented the ASO prevention and nursing intervention program for diabetic patients based on the risk prediction model and the HAPA model. The intervention was divided into four stages. The first stage was the pre-intention stage, in which face-to-face communication was adopted to improve patients' disease cognition. The second stage was the intention stage. This stage involves converting patients' behavioral intentions into practical actions through knowledge education, skill guidance, etc. The third stage is the action stage, where healthy behaviors are generated and maintained through providing social support, supervision and evaluation, etc.

06

What researchers measure

Primary outcomes

  1. ankle brachial index, ABI

    Time frame: Collected respectively before the intervention and at 1, 3, and 6 months after the intervention

  2. Summary of Diabetes Self Care Activities, SDSCA

    This scale is used to assess the self-management ability of diabetic patients. It consists of 12 items, each of which is calculated on an 8-point scale ranging from 0 to 7. Individuals choose a score of 0 to 7 based on the number of days they have implemented it. The higher the score, the better the self-management ability. A score of 80 or above indicates good self-management ability, 60 to 80 indicates medium self-management ability, and below 60 indicates poor self-management ability.

    Time frame: Collected respectively before the intervention and at 1, 3, and 6 months after the intervention

Secondary outcomes

  1. Diabetes Specific Quality of Life Scale, DSQL

    DSQL is a specific quality of life scale designed for Chinese diabetic patients, consisting of 27 items in four dimensions: physiological, psychological, social and therapeutic. The total score ranges from 27 to 135 points. The higher the score, the worse the quality of life. The reference cut-off values are as follows: a score below 54 is considered good, 55 to 81 is medium, and a score above 82 indicates a poor quality of life. This scale has good reliability, validity and responsiveness, and is suitable for evaluating the current quality of life and intervention effects of Chinese diabetic patients.

    Time frame: Collected respectively before the intervention and at 1, 3, and 6 months after the intervention

  2. The Third Version of Diabetes Attitude Scale, DAS-3

    The DAS-3 scale consists of five dimensions: Professional training needs, severity of type 2 diabetes, the value of strict blood sugar control, psychosocial impact and patient autonomy were scored using a 5-point Likert scale (1= strongly disagree, 5= strongly agree). Among them, the reverse scoring items needed to be converted to 6 minus the original score. The final score of each dimension was the average score of all items processed under that dimension. The higher the score, the more positive the attitude and the more in line with modern diabetes management concepts

    Time frame: Collected respectively before the intervention and 1, 3, and 6 months after the intervention

07

Study locations

1 of 1 sites recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jang XI 330006, China
    Recruiting
08

References and documents

Study documents

  • Study protocol · Apr 18, 2024
  • Informed consent form · Apr 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881588
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Apr 15, 2025
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Yujin Yang
Contact
18979136718@163.com
18979136718

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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