Evaluation of the Impact of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus: Pilot Study "NOVAME"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The objective of this project is to evaluate the effectiveness and cost effectiveness of a health app (NOVAME) designed to improve the self-control of patients with T2DM and their health outcomes. The central focus of NOVAME is the continuous support to the patient and monitoring through the app that will act as a personalized and dynamic virtual coach that will help the patient to adopt healthy habits and change their behaviors through training plans in different areas: exercise physical, healthy eating, therapeutic education and emotional management The design of the evaluation is the randomized clinical trial, in the intervention arm patients will use the app NOVAME and in the control group, patients don't receive any additional educational or supporting activities beyond the usual activities provided by the Canary Islands Health Service (CIHS). The main outcome measure is the change in HbA1c at 3 months, requiring a total of 197 patients to detect a difference of at least 0.4% considering a 10% loss. As secondary measures HbA1c is collected at 12 months and other biochemical results (lipids and glucose), BMI and a series of questionnaires to measure changes in life habits (diet, physical activity), anxiety and depression, knowledge about their disease , degree of empowerment, satisfaction and usability of the app, .. Will be collected at 3 and 12 months. The differences between the arms will be measured with mixed generalized linear models. The cost effectiveness will be calculated by calculating life years adjusted for quality (QALY) and the cost of the disease, including the use of resources reported by patients. The benefits of the technology will be expressed in terms of HbA1c and QALY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Researchers who recruited participants and applied the baseline and 3-month questionnaires were not blinded to the allocation sequence. Given the nature of the intervention patients could not be blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with T2DM diagnosed at least one year prior to study enrolment
- •18-65 years of age
- •Formal consent to participate in the study
- •Regular use of mobile phone
排除标准
- •Chronic kidney disease≥stage 3b, as defined by the National Kidney Foundation's Kidney Disease Outcomes and Quality Improvement Initiative (KDOQI); urinary albumin to creatinine ratio (UACR) ≥ 300 mg/g and/or urinary protein excretion ≥ 300 mg/24 hours.
- •Acute coronary syndrome (documented angina or myocardial infarction) or stroke in the last six months or class III or IV heart failure, according to the New York Heart Association (NYHA).
- •Proliferative diabetic retinopathy or clinically significant diabetic macular edema requiring previous treatment with retinal photocoagulation, vitrectomy, or intravitreal injections of antivascular endothelial growth factor or triamcinolone acetonide 6 months prior to study inclusion.
- •Uncorrected severe hearing or visual impairment; or corrected visual acuity ≤ 20/40 by any cause.
- •Diabetic foot with ulcers ≥ 2 according to Wagner scale.
- •Liver cirrhosis
- •Cancer unless disease free five years after diagnosis
- •Other terminal illnesses
- •Intellectual retardation, dementia, psychotic diseases.
- •Active substance abuse, alcohol or drugs (must be sober for one year)
- •Insufficient (Spanish) language skills
- •Physical disability limiting participation in group education activities
- •Concurrent participation in another clinical trial or any other investigational study.
结局指标
主要结局
HbA1c
时间窗: Baseline, 3 months, 12 months
glycosylated hemoglobin
次要结局
- Total cholesterol and its fractions (LDL, HDL and nonHDL), and triglycerides(Baseline, 3 months, 12 months)
- Glucose(Baseline, 3 months, 12 months)
- BMI(Baseline, 3 months, 12 months)
- Quality of life related to health(Baseline, 3 months, 12 months)