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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Diabetes Mellitus, Peripheral Arterial Disease

Being tested

Routine Care, Experimental group intervention

Medical subject headings

Diabetes Mellitus, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Routine CareOther

  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.

• Experimental group interventionBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. ankle brachial index, ABI

   Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Oct 2026
2. Study start15 Apr 2025
3. Primary completion1 Oct 2027 (estimated)
4. Study completion1 Dec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Diabetes MellitusStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.