Effect of Smartphone App on Activity
Primary Purpose
Diabetes Type 2, Hematologic Malignancy
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
messages generated by learning algorithm
constant weekly message reminding patient to exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Type 2
Eligibility Criteria
Inclusion Criteria:
- Age over 18.
- Diagnosis of diabetes type 2 with HbA1c over 6.5% and no regular exercise for arm A.
- Newly diagnosed lymphoma, CLL or MM which require chemotherapy for arm B.
- Patients in both arms should hold an android based smartphone.
- Patients must be able to read Hebrew.
Exclusion Criteria:
- Unable to legally consent
- unstable or stable angina pectoris
Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Learning algorithm
control
Arm Description
The app will be installed on the patients's phone. The app will measure the amount of activity performed. THE INTERVENTION IS THAT the Patients will receive daily messages, a learning algorithm will study the exercise response to each type of message and personalize the best message sequence for each patient.
The app will be installed on the patients's phone. The app will measure the amount of activity performed. THE INTERVENTION IS THAT THE Patients will receive a weekly reminder to exercise.
Outcomes
Primary Outcome Measures
increase in daily physical activity
The app records the amount of daily walking using the smartphone accelerometer. The amount of activity and pace of walking is compared to those performed on previous days.
Secondary Outcome Measures
glycemic control
HbA1c will be measured before recruitment and every 3 months during participation. The HbA1c during participation will be compared to the starting HbA1c to assess whether there was improvement in glycemic control as quantified by HbA1c.
Full Information
NCT ID
NCT02612402
First Posted
November 17, 2015
Last Updated
November 20, 2015
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02612402
Brief Title
Effect of Smartphone App on Activity
Official Title
The Effect of a Smartphone Application for Encouraging Physical Activity on the Amount of Activity Performed by Patients With Diabetes or Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A smartphone app will be installed on smartphones of patients with type 2 diabetes or hematologic malignancies that do not exercise. The app will send SMS messages to encourage exercise. The exercise will be quantified by the smartphone accelerometer and clinical data, including HbA1c will be collected.
Detailed Description
The aim of the study is to increase patients' physical activities by using a dedicated cellular application that will encourage patients to adhere to their doctor recommendation on a personal basis.
Primary outcome In diabetic patients: measuring an increase in daily physical activity In cancer patients: improvement of quality of life in correlation with the level of physical activity
Secondary outcomes In diabetic patients: improved glycemic control as assessed by sequential blood tests for HbA1c.
The patients will fill quality of life questionnaires (SF36) at recruitment and after 6 months. After 6 months the patients will also fill a questionnaire about their experience of using the app.
Each recruited patient will have an Android based smart phone. Each patient will provide:
Approval to join the experiment
Age, gender, height
Telephone number (for SMS)
Length of intervention - at least 6 months per patient. Each patient will be randomly assigned into one of two groups, which will specify feedback relative to himself or to others or a weekly reminder to exercise.
Number of patients:
Diabetes: 150 patients, of which 50 are controls.
Cancer: 100 patients, of which 20 are controls. All patients will receive instruction about the importance of physical activity and a personal recommendation for activity level, n sessions of activity per week, and time span per session (i.e., at least 2 hours of walking per week divided to 3 walking sessions per week) Patients in the treatment arms will receive at least n (number of commended sessions) messages per week of positive feedback if activity performed or negative feedback if not performed. At the chosen day each week the patient will receive a summary of the exercise for all the week.
Feedback Possible feedback
(NOTE - these the the actual feedback messages that the participants will receive, and are therefore in the second person):
Negative feedback: "You need to exercise to reach your activity goals. Please remember to exercise tomorrow".
Positive feedback:
Relative to self: "You're exercise level is higher than last week. Keep up the good work"
Relative to others: "You're exercising more than the average person. Keep up the good work"
Control arm: "Did you remember to exercise?"
Technical requirements
App - will collect physical activity and send it to a server. App will run in background without need to restart on reboot.
Server - Collects physical activity
Feedback policies The experiment will have two phases of feedback. Phase 1
The investigators begin with no data, so the policy at this stage is as follows:
Positive feedback will be sent each day if user has surpassed 1/7th of weekly activity that day.
Negative feedback will be sent every 3 days, if activity hasn't passed 1/7th of activity.
Each day, with a probability of 0.2, a random decision on feedback will be made.
This phase will last approximately 4 weeks. Phase 2 Using a learning algorithm (see below) the computer will adjust the feedback, and decide daily on the feedback (positive \ negative \ none).
Policy learning The investigators will start with a simple policy learning strategy, and later use more sophisticated methods that will have a state-space representation of the user.
The initial algorithm will represent each user at each day using the following attributes:
Demographics (age and gender)
Expected versus actual activity level this week (ratio of the two)
Last feedback given (positive \ negative)
Day of the week (we will use week-long cycles). The goal of the algorithm is to give feedback today so as to encourage activity tomorrow.
When training the algorithm, the computer will have a feature vector comprising of the attributes above, and a matrix of actions (for day t). The output to be predicted is whether the activity level on the following day (t+1).
There can be two types of feedback depending on weekly and daily behaviors:
Weekly goal Not achieved Achieved Daily goal (on day (t+1)) Not achieved 1 1+alpha Achieved 1+alpha 1 (alpha>0) The algorithm will pay a higher penalty if, for example, on a given day the message encouraged activity, but the weekly goal was not achieved compared to if it was.
For simplicity, the initial learning algorithm will be linear, until enough data is collected. That is, given a matrix:
X = (demographics, expected vs. actual activity, last feedback, day of the week, actions) And a vector showing the amount of activity on the following day, weighted as in the table above, denoted by Y, we will learn a vector of weights w such that: X * w = Y.
In phase 2 of the project the computer will use other learning algorithms. Exploration (random action at a given day) will continue throughout both phases at the same level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Hematologic Malignancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Learning algorithm
Arm Type
Experimental
Arm Description
The app will be installed on the patients's phone. The app will measure the amount of activity performed. THE INTERVENTION IS THAT the Patients will receive daily messages, a learning algorithm will study the exercise response to each type of message and personalize the best message sequence for each patient.
Arm Title
control
Arm Type
Active Comparator
Arm Description
The app will be installed on the patients's phone. The app will measure the amount of activity performed. THE INTERVENTION IS THAT THE Patients will receive a weekly reminder to exercise.
Intervention Type
Device
Intervention Name(s)
messages generated by learning algorithm
Intervention Description
THIS INTERVENTION HAS BEEN INCLUDED IN THE LEARNING ALGORITHM ARM The app measures physical activity by the phone accelerometer and sends SMS messages to encourage activity. An automatic learning algorithm for encouraging physical activity learns the patterns of response for each patient and chooses the best messages for the patient to encourage activity.
Intervention Type
Device
Intervention Name(s)
constant weekly message reminding patient to exercise
Intervention Description
THIS INTERVENTION HAS BEEN INCLUDED IN THE CONTROL ARM The app measures physical activity by the phone accelerometer and sends a constant SMS messages to remind the patient to exercise.
Primary Outcome Measure Information:
Title
increase in daily physical activity
Description
The app records the amount of daily walking using the smartphone accelerometer. The amount of activity and pace of walking is compared to those performed on previous days.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
glycemic control
Description
HbA1c will be measured before recruitment and every 3 months during participation. The HbA1c during participation will be compared to the starting HbA1c to assess whether there was improvement in glycemic control as quantified by HbA1c.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18.
Diagnosis of diabetes type 2 with HbA1c over 6.5% and no regular exercise for arm A.
Newly diagnosed lymphoma, CLL or MM which require chemotherapy for arm B.
Patients in both arms should hold an android based smartphone.
Patients must be able to read Hebrew.
Exclusion Criteria:
Unable to legally consent
unstable or stable angina pectoris
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irit a Hochberg, MD/PhD
Phone
+97247772150
Email
i_hochberg@rambam.health.gov.il
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irit Hochberg, MD/PhD
Phone
+972-4-7772150
Email
i_hochberg@rambam.health.gov.il
12. IPD Sharing Statement
Citations:
PubMed Identifier
26822328
Citation
Hochberg I, Feraru G, Kozdoba M, Mannor S, Tennenholtz M, Yom-Tov E. Encouraging Physical Activity in Patients With Diabetes Through Automatic Personalized Feedback via Reinforcement Learning Improves Glycemic Control. Diabetes Care. 2016 Apr;39(4):e59-60. doi: 10.2337/dc15-2340. Epub 2016 Jan 28. No abstract available.
Results Reference
derived
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Effect of Smartphone App on Activity
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