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Diabetes Type 2NCT02612402

Effect of Smartphone App on Activity

A study testing messages generated by learning algorithm and constant weekly message reminding patient to exercise in people with Diabetes Type 2 and Hematologic Malignancy, run by Rambam Health Care Campus at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Diabetes Type 2, Hematologic Malignancy
What is being tested?
messages generated by learning algorithm and constant weekly message reminding patient to exercise
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteIsrael
Study dates
Jul 2014to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Unable to legally consent
  • unstable or stable angina pectoris

Trial locations and contacts

1 site in 1 country.

Irit a Hochberg, MD/PhD contact

+97247772150

i_hochberg@rambam.health.gov.il

Israel1 site, 1 recruiting
  • Rambam Health Care Campus

    Haifa

    Irit Hochberg, MD/PhD, +972-4-7772150, i_hochberg@rambam.health.gov.il

    Recruiting

Other trials in Israel

About this study

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

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.

Read the 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:

  1. Approval to join the experiment
  2. Age, gender, height
  3. 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:

  1. Diabetes: 150 patients, of which 50 are controls.
  2. 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):

  1. Negative feedback: "You need to exercise to reach your activity goals. Please remember to exercise tomorrow".
  2. Positive feedback:
  3. Relative to self: "You're exercise level is higher than last week. Keep up the good work"
  4. Relative to others: "You're exercising more than the average person. Keep up the good work"
  5. Control arm: "Did you remember to exercise?"

Technical requirements

  1. App - will collect physical activity and send it to a server. App will run in background without need to restart on reboot.
  2. 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:

  1. Positive feedback will be sent each day if user has surpassed 1/7th of weekly activity that day.
  2. 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:

  1. Demographics (age and gender)
  2. Expected versus actual activity level this week (ratio of the two)
  3. Last feedback given (positive \ negative)
  4. 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.

Being tested
messages generated by learning algorithm, constant weekly message reminding patient to exercise
Medical subject headings
Diabetes Mellitus, Type 2, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • messages generated by learning algorithmDevice

    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.

  • constant weekly message reminding patient to exerciseDevice

    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.

Study groups in NCT02612402
Study groupRoleWhat they receive
Learning algorithmExperimentalThe 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.
Receives: Device: messages generated by learning algorithm
controlActive comparatorThe 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.
Receives: Device: constant weekly message reminding patient to exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (1)
  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02612402
Sponsor's protocol ID
0090-14-RMB
Status last verified
Nov 2015
First submitted
17 Nov 2015
Last updated
23 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26822328

Questions about this trial

What is this clinical trial studying?

A study testing messages generated by learning algorithm and constant weekly message reminding patient to exercise in people with Diabetes Type 2 and Hematologic Malignancy, run by Rambam Health Care Campus at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Irit a Hochberg, MD/PhD (+97247772150, i_hochberg@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

increase in daily physical activity (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02612402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.

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