Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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:
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:
Control arm: "Did you remember to exercise?"
Technical requirements
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Learning algorithm | Experimental | 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. |
|
| control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| messages generated by learning algorithm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irit a Hochberg, MD/PhD | Contact | +97247772150 | i_hochberg@rambam.health.gov.il |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Recruiting | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26822328 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| constant weekly message reminding patient to exercise | Device | 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. |
|
| D004700 | Endocrine System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |