Clinical trial NCT03663738: Impact Evaluation of a Mobile Health App to Improve Self-control and Health Outcomes of Patients With Type 2 Diabetes Mellitus (T2DM): Pilot Study "NOVAME"
Official title: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients with T2DM diagnosed at least one year prior to study enrolment
2. 18-65 years of age
3. Formal consent to participate in the study
4. Regular use of mobile phone

Exclusion Criteria:

1. 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.
2. 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).
3. 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.
4. Uncorrected severe hearing or visual impairment; or corrected visual acuity ≤ 20/40 by any cause.
5. Diabetic foot with ulcers ≥ 2 according to Wagner scale.
6. Liver cirrhosis
7. Cancer unless disease free five years after diagnosis
8. Other terminal illnesses
9. Intellectual retardation, dementia, psychotic diseases.
10. Active substance abuse, alcohol or drugs (must be sober for one year)
11. Pregnancy
12. Insufficient (Spanish) language skills
13. Physical disability limiting participation in group education activities
14. Concurrent participation in another clinical trial or any other investigational study.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Total cholesterol and its fractions (LDL, HDL and nonHDL), and triglycerides
timeFrame: Baseline, 3 months, 12 months
measure: Glucose
timeFrame: Baseline, 3 months, 12 months
measure: BMI
timeFrame: Baseline, 3 months, 12 months
measure: Quality of life related to health
timeFrame: Baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación. Servicio Canario de Salud
Study officials:
References: