- ICH GCP
- US Clinical Trials Registry
- 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" (NOVAME)
February 26, 2020 updated by: Servicio Canario de Salud
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"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
199
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santa Cruz de Tenerife, Spain, 38004
- Servicio de Evaluación. Servicio Canario de Salud
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: health mobile app for T2DM patients
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
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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.
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No Intervention: Control
Receives the usual care as established in the Canary Islands Atherosclerotic Vascular Disease Prevention and Control Program (EVA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Baseline, 3 months, 12 months
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glycosylated hemoglobin
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Baseline, 3 months, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total cholesterol and its fractions (LDL, HDL and nonHDL), and triglycerides
Time Frame: Baseline, 3 months, 12 months
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triglycerides, Total Cholesterol, LDL Cholesterol, HDL Cholesterol
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Baseline, 3 months, 12 months
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Glucose
Time Frame: Baseline, 3 months, 12 months
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glucose level
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Baseline, 3 months, 12 months
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BMI
Time Frame: Baseline, 3 months, 12 months
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Body mass index
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Baseline, 3 months, 12 months
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Quality of life related to health
Time Frame: Baseline, 3 months, 12 months
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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.
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Baseline, 3 months, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2018
Primary Completion (Actual)
September 20, 2019
Study Completion (Actual)
September 20, 2019
Study Registration Dates
First Submitted
September 6, 2018
First Submitted That Met QC Criteria
September 6, 2018
First Posted (Actual)
September 10, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIFUN32/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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