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"

NCT03663738 | Completed

• 1 other identifier: PIFUN32/17
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  glycosylated hemoglobin

  Baseline, 3 months, 12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

health mobile app for T2DM patients

ACTIVE COMPARATOR

It consists of a mobile app that will be provided to patients during a period of 12 months, the patient can also continue with the usual care. The application will be synchronized with a server where all the information is recorded for further analysis. The central focus of the application consists of continuous support and monitoring through the app that has 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

Behavioral: mobile app NOVAME

Control

NO INTERVENTION

Receives the usual care as established in the Canary Islands Atherosclerotic Vascular Disease Prevention and Control Program (EVA)

Interventions

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.

health mobile app for T2DM patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM diagnosed at least one year prior to study enrolment
• years of age
• Formal consent to participate in the study
• Regular use of mobile phone

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Servicio Canario de Salud: lead

Study Sites (1)

Servicio de Evaluación. Servicio Canario de Salud

Santa Cruz de Tenerife, 38004, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: February 5, 2018
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)