Prescription Zero: A non-pharmaceutical prescription device for prescribing, administering, monitoring, measuring and motivating a therapeutic lifestyle regimen for prevention and treatment of chronic diseases

• US 20110046519A1
• Filed: 08/21/2009
• Published: 02/24/2011
• Est. Priority Date: 08/21/2009
• Status: Active Grant

• Current Assignee: Fazal Raheman
• Original Assignee: Fazal Raheman
• Inventors: Raheman, Fazal
• Granted Patent: US 8,303,500 B2
• Time in Patent Office: Days
• US Class Current: 600/595
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/112 Gait analysis
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The invention discloses a wearable/handheld personal communication device with hardware and software sensor modules that sense and analyze all caregiver prescribed/monitored user-lifestyle activities, and deploys such analysis in improving user'"'"'s overall health in terms of reduced risks for all-cause morbidities/mortalities and eventually a life without drugs. Termed Rx Zero, such method may be prescribed not just for maintaining a healthy lifestyle, but for treatment of chronic diseases with intent to wean the patients to minimal or zero pharmacological intervention, or in combination with medications to improve prognosis of the disease under treatment.

The benefits of the Rx Zero method of the present invention extend not only to the individual and the community through high quality healthcare at lower cost, but payers by reducing the loss ratio on account of reduced cost of medical claims, and to the caregivers in terms of an effective tool that disseminates, implements and redefines “Primary Health Care” and “Prevention” at levels beyond the terms'"'"' currently understood scope that has transformed healthcare to sickcare.

Claims

1. A non-pharmaceutical method of achieving zero drug intervention (Rx Zero) in treatment and prevention of chronic diseases by means of prescribing, administering, measuring, quantifying, monitoring, motivating and implementing a lifestyle behavior modification approach involving therapeutic physical activity and related dietary and behavioral lifestyle changes resulting in consequent health benefits in terms of risk reduction for future morbidities/mortalities, prognosis for current morbidities, reduction, weaning out or elimination of the long term pharmaceutical drugs, and rewards therein for achieving the prescribed lifestyle goals, comprising of:

a) a wearable/handheld communication device or a personal user device, which may be a mobile wearable computer, a PDA or a mobile phone;

b) a sensor module comprising of;

i. the first sensor sub-module wherein the sensor is a physical activity sensing MEMS (Micro Electro Mechanical System) single, double or triple axis accelerometer hardware sensor and a device activity sensing software sensor application either integrated within a hand held communication device, or resident in a disparate wireless device attached to user'"'"'s body, or to user'"'"'s apparel, or to a personal communication device carrying case, or to the exercise apparatus such as a bicycle or a treadmill, in each of which case it communicates wirelessly with the handheld communication device using close range radiofrequency transmission, and,

ii. the second sensor sub-module wherein the sensor is a software client sensor application that monitors user'"'"'s usage of the different functions of the handheld communication device that is analyzed to provide the user'"'"'s free-living lifestyle that includes sleep patterns, physical activity patterns, socializing patterns, and also to provide greater accuracy of the accelerometer measurements by switching the accelerometer to sleep mode when the device is connected to the external power source for charging or when the user goes to sleep.

c) a distributed sensor data analysis module, which is a client-server application that has a client-resident local analysis sub-module and a server resident global analysis sub-module operating in tandem to analyze the free-living sensing data generated by the sensor module, and output as user readable outcome that includes steps walked, calories consumed, morbidity risk reduced, treatment prognosis improved, prescription compliance achieved;

d) a central server or data repository module, which is a database of user profiles that include user'"'"'s personal health-related information such as age, sex, smoking, substance abuse, dietary habits, body mass index, morbidities, and corresponding sensor module-sensed user activities that the user of any one or more of the modules of the system can access at anytime and utilize for reference, inference, analysis, action and display;

e) the caregiver services module, which is a World Wide Web enabled server application that allows the authorized doctor, nurse or related paramedic from the caregiver healthcare infrastructure, to prescribe, monitor, alter, counsel or remind prescription compliance of the patient'"'"'s lifestyle activities through a Web browser interface from any client computer or communication device connected to the Internet by means of either direct audio or instant text messages or by means of changes in the data repository module (database);

f) The payer services module, which is a World Wide Web enabled server application deploying actuarial algorithm that allows the third party payer/insurer of the healthcare services to automatically estimate changes in patient'"'"'s health insurance premium based on the changed health parameters analyzed by the data analysis module and authorize corresponding alteration in the health insurance premium automatically or manually through a browser interface from any client computer or communication device connected to the Internet;

g) The user health status dashboard GUI module, which displays user'"'"'s health indices in the form of distance traversed and calories burnt, and combines them with the device-measured lifestyle routines that include sleeping, resting and activity patterns, and user-profiled lifestyle traits that include smoking, drug use, dietary habits, body mass index and morbidities, to display to the user the therapeutic lifestyle targets achieved, morbidities reduced and prognosis improved, either on the output inlay of the user'"'"'s handheld communication device or via an active server webpage accessed through any computer connected to the Internet.

2. The method of claim 1, wherein the sensor data analysis module implements a vector filtering algorithm that uses a reference human stride motion pattern to automatically analyze the patterns of acceleration in X, Y and Z axes by using:

a) the perpendicular acceleration filter,

b) the gravity acceleration filter,

c) the reverse acceleration filter,

d) the orientation filter, and,

e) the anti-aliasing filter,

for filtering the longitudinal acceleration data that does not confer with the reference pattern of human stride, such confounding motions include alternate reverse velocity in a conventional treadmill walk, or the non-human stride motions such as high speed steady velocity of a vehicle ride or bike ride, or sporadic movements of the device such as for making or receiving a voice call.

3. The method of claim 1, wherein the sensor data analysis module implements a sub-module that uses a manual or automatic override algorithm when the user device incorporates a RF transponder module that detects RF signals from a synchronized RF transducer-equipped exercise equipment so that the velocity metrics of the exercise equipment based acceleration take precedence over the user device based accelerometer.

4. The method of claim 1, wherein the Rx Zero therapeutic dose of physical activity for a completely sedentary but ambulatory patient on low calorie diet is not less than 20,000 steps per week for the first four weeks, not less than 40,000 steps per week for the next four weeks and 50,000 to 70,000 steps permanently thereafter, or not less than 500 MET-minutes per week for the first four weeks, not less than 1,000 MET-minutes for the next four weeks and 1,200 to 1800 MET-minutes permanently thereafter.

5. The method of claim 1, wherein the dietary goal of the Rx Zero includes a high fiber low calorie diet that is not less than 10 calories per pound of body weight and not more than 15 calories per pound of body weight, and includes diet with high intake of fruits, vegetables, nuts and legumes, whole grains and low-fat dairy products, and low or no intake of sweetened beverages, processed foods and red meat.

6. The method of claim 1, wherein the rewards for achieving the goals include:

a) to the individual user/patient, monitory benefits such as reduction in the health insurance premium corresponding to the levels lifestyle change reached, and non-monetary rewards such as improved health, reduce morbidity/mortality risk, improved treatment prognosis, better patient-caregiver interaction, motivational messages and promotional offers;

b) to the community, improved health status with good quality healthcare at lower cost to the economy;

c) to the caregiver and policy makers, an effective tool that disseminates and implements “

Primary Health Care” and

“

Prevention”

at all levels of healthcare and beyond the currently understood scope of these terms; and

;

d) to the payer/insurer, decline in loss ratio on account of reduced claims.

7. The method of claim 1 wherein Rx Zero is a completely non-pharmaceutical lifestyle behavior modifying intervention, which avoids, minimizes or eliminates the prescription of pharmaceutical agents in management of chronic morbidities, and which is prescribed as the first and primary prescription limiting the use of prescription drugs only to supplement the Rx Zero treatment until the time such medications are absolutely necessary in treatment of life style related chronic diseases such as hypertension, hyperlipidemia, endothelial dysfunction, metabolic syndrome, obesity, coronary artery disease, stroke, diabetes, or certain cancers such as breast cancer, prostate cancer, colorectal cancer and pancreatic cancer.

8. The method of claim 1, wherein the prescribing, administering, measuring, quantifying, monitoring, motivating and implementing a lifestyle behavior modification approach is deployed to meet specialized lifestyle needs of women pre, post and during pregnancy for shorter labor and easier pregnancy with fewer complications.