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NCT Number: 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"

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación. Servicio Canario de Salud

Santa Cruz de Tenerife, 38004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Pregnancy
  • Insufficient (Spanish) language skills
  • Physical disability limiting participation in group education activities
  • Concurrent participation in another clinical trial or any other investigational study.

Treatment and study plan

mobile app NOVAME

Behavioral

The training program is divided into 3 periods of 21 days, where each day the patient receives a new formation pill. At the end of one of these periods there will be a week of review in which the patient will receive reminders of the contents that he has already received. These pills will help the patient to acquire healthy lifestyle habits and improve the control of the disease. The length of the program is 84 days, and once completed, the patient can repeat or intensify efforts in the areas he considers and continue to have access to the virtual coach. Patients assigned to the intervention group will receive a brief structured explanation on how to use the application and its contents.

Primary outcomes

  1. HbA1c

    Time frame: Baseline, 3 months, 12 months

    glycosylated hemoglobin

Secondary outcomes

  1. Total cholesterol and its fractions (LDL, HDL and nonHDL), and triglycerides

    Time frame: Baseline, 3 months, 12 months

    triglycerides, Total Cholesterol, LDL Cholesterol, HDL Cholesterol

  2. Glucose

    Time frame: Baseline, 3 months, 12 months

    glucose level

  3. BMI

    Time frame: Baseline, 3 months, 12 months

    Body mass index

  4. Quality of life related to health

    Time frame: Baseline, 3 months, 12 months

    EQ-5D-5L questionnaire. The EQ-5D is a generic instrument of HRQL measurement where the individual assesses their state of health, first in levels of severity by dimensions (descriptive system) and then in a visual analogue scale (VAS) of more general evaluation. The index ranges between the value 1 (best health status) and 0 (death), although there are negative values for the index, corresponding to health status that are valued as worse than death.

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Registry information

Official study 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"

Acronym: NOVAME

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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