跳至主要内容
临床试验/CTRI/2025/09/095036
CTRI/2025/09/095036尚未招募不适用

Design and development of a self-management post-operative follow-up mobile application for patients with Diabetic foot.

MARIANNE SHRADDHA DSILVA1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
1. Identify the user requirements for post-operative care of diabetic foot patients.

研究概览

简要总结

Design and development of a self-management post-operative follow-up mobile application for patients with Diabetic foot

Purpose of the Study:

To design and develop a mobile application to improve health literacy among patients with diabetic foot post debridement/amputation by providing post-operative care follow-up instructions to prevent or minimise surgical site infection (SSI)

Methodology:

Identify user requirements for post-operative care of diabetic foot patients by conducting an in-depth interview (IDI) with medical doctors to determine key elements and metrics needed to be incorporated while designing the mobile application for wound care and monitoring the wound healing process. The analysis of the data will be done using Thematic Analysis software.

A recorder will be used, for which the consent from the participant will be taken before use.

Design a mobile application prototype for post-operative care instructions of diabetic foot patients using the information from the IDI.

3) The software application will be developed using React Native, Flutter, etc. The development of the application will use the Agile Methodology approach.

4)The application will include the following features

A) A to-do list for post-operative wound dressing protocol.

B) A visual schedule for the wound dressing time.

C) A patient questionnaire checklist and regular vital signs (Body temperature, Blood Glucose and Blood Pressure) monitoring to check the state of the site. A prompt if there is an indication of fever.

D) A tabulated calendar of prescribed medications (weekly basis).

Patient data privacy will be safeguarded by adhering to the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) compliance protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria for Information Gathering: Specialisation: Medical Doctors specialising in diabetic foot care: podiatrists, endocrinologists and vascular surgeons.
  • Experience: At least 2 years of experience in treating diabetic foot patients.
  • Inclusion Criteria for Usability Testing:
  • Patients who have undergone surgery for diabetic foot.
  • Consenting patients.
  • Patients who can use a smartphone or have a caregiver to assist with using the application.
  • Patient or caregiver who can speak and understand the language in which the application is designed.

排除标准

  • Exclusion Criteria for Information Gathering: Experience:
  • Doctors with less than 2 years of experience in diabetic foot care.
  • Specialists who are not willing to participate in the study.
  • Exclusion Criteria for Usability Testing:
  • Patients without access to a smartphone who are required to test the application.
  • Non-consenting patients.

结局指标

主要结局

1. Identify the user requirements for post-operative care of diabetic foot patients.

时间窗: 1) 3 months | 2) 9 months

2. Design and develop a mobile application for post-operative care instructions of diabetic foot patients

时间窗: 1) 3 months | 2) 9 months

次要结局

未报告次要终点

研究者

发起方
MARIANNE SHRADDHA DSILVA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MARIANNE SHRADDHA DSILVA

MGM School Of Biomedical Sciences, MGMIHS, NM

研究点 (1)

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