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Clinical Trials/NCT02612402
NCT02612402UnknownNot Applicable

The Effect of a Smartphone Application for Encouraging Physical Activity on the Amount of Activity Performed by Patients With Diabetes or Hematological Malignancies

Rambam Health Care Campus1 site in 1 country270 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
270
Locations
1
Primary Endpoint
increase in daily physical activity

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: messages generated by learning algorithm (Device)

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.

Intervention: constant weekly message reminding patient to exercise (Device)

Outcomes

Primary Outcomes

increase in daily physical activity

Time Frame: 6 months

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 Outcomes

  • glycemic control(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Irit HOCHBERG MD

Attending physician, Institute of Endocrinology, Diabetes and Metabolism

Rambam Health Care Campus

Study Sites (1)

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