A Feasibility Study to Explore the Implementation and Acceptance of INTELLIN, a Novel mHealth Application on the Management of People With Diabetes Who Have Recently Healed Foot Ulceration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- 1 Acceptability, suitability and usability of the INTELLIN platform
研究概览
简要总结
This is a novel feasibility study to test the participant acceptance and usability of a specifically designed smart phone app. It will also explore the effects of smart phone technology in improving self-referrals into the diabetic foot ulcer (DFU) service. Furthermore, it will be explored if this increase in self-referrals will influence the outcome of people with diabetes who have recently had a healed foot ulceration.
详细描述
The rationale behind this study is if the investigators can introduce a new technology (a smart phone app) which is acceptable to patients, engages them and prompts people to take preventative health behaviours then the investigators may be able to influence the low rates of appropriate self-referral. There is evidence that links poor glycaemic control and hypertension to DFUs, so engagement in these areas of wider diabetes management needs to be reviewed, the latest National Diabetes Audit (NDA) shows only 20% of people with Type 1 and 42% of people with Type 2 diabetes achieve the 3 NICE standards for HbA1c, BP and cholesterol. In addition, healthcare providers are being asked to investigate new systems that may increase patient engagement with and the uptake of the NICE 8 annual care processes. The latest NDA shows only 40% of patients with type 1 and 60% of patients with type 2 diabetes currently have all 8 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 18 years of age will be screened to meet the eligibility criteria:
- •Consultant or GP diagnosis of diabetes mellitus (Type I or II) , documented on the electronic patient record with HbA1C greater than 48mmol/mol
- •History of a recent diabetes foot ulcer defined as being eligible for the national diabetes foot audit and classified as healed for at least 4 weeks and no more than 12 weeks
- •Able to provide informed consent
- •Has no reasons that they could not be part of the study for 12 months such as moving out the area for attending appointments or short life expectancy from a diagnosed illness
- •Owns a smart phone
排除标准
- •No smart phone
- •Comorbidity such as poor eyesight which limits the use of smart phone
- •Participation in an interventional study within the last 30 days
- •Critical illness that prevents participating for a period of time
结局指标
主要结局
1 Acceptability, suitability and usability of the INTELLIN platform
时间窗: 12 months
A 5-point rating scale as assessed by the participants and the clinical team. The 5 point rating is a likert scale where respondants are offered a choice of 5 pre coded responses 1 being strongly disagree 2 disagree 3 (neutral point) niether disagree or agree 4 agree and 5 strongly agree so the individual can express how much they agree or disagree with the experience of using the application
The proportion of patients who self-refer for recurrence of diabetic foot-ulcer over a twelve-month period, compared with the current National diabetes foot audit average of 33.3%
时间窗: 12 months
Proportion of participants self-referring using the Intellin platform SOS button over 12 months compared with the current National diabetes foot audit average of 33.3%
次要结局
- The proportion of patients with recurrence of foot ulcer over 12 months(12 months)
- Proportion of patients who would recommend Intellin platform to others(12 months)
- Proportion of patients who discontinue the study because they are unable to use the app(12 months)
- Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60%(12 months)
- Changes in cardiovascular markers(12 months)
- Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines(12 months)
- Time to recurrence of ulcer over 12 months.(12 months)
- The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers(12 months)
- Proportion of patients who access the Intellin app every day(12 months)
- The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks(12 months)
- The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes(12 months)
- The effect of using INTELLIN on quality of life(12 months)
- The proportion of patients with lower limb amputations(12 months)
研究者
Natalie Garratt
Research & Development Lead
Northern Care Alliance NHS Foundation Trust