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 8,303,500 B2
• Filed: 08/21/2009
• Issued: 11/06/2012
• Est. Priority Date: 08/21/2009
• Status: Expired due to Fees

• Current Assignee: Fazal Raheman
• Original Assignee: Fazal Raheman
• Inventors: Raheman, Fazal
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US12/545,172
• Publication Number:
  US 20110046519A1
• Time in Patent Office: 1,173 Days
• Field of Search: 600/300, 600/301, 600/595, 705/2, 705/4
• US Class Current: 600/301
• 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 and prescription device for achieving a goal of 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 and mortalities, prognosis for current morbidities, reduction, weaning out, or elimination of chronic pharmaceutical intervention, and rewards accruing for achieving a prescribed lifestyle goal, comprising of:

a) either a wearable or a handheld communication device or a personal user device, which may be a mobile wearable computer, a PDA or a mobile phone that is capable of performing, recording and displaying data regarding user'"'"'s free-living lifestyle usage of functions pertaining to telecommunication, surfing Internet, playing music, power management, recording physical movements, and recording periods of inactivity that occurs during user'"'"'s sleep or during a period the device is connected to external power source for charging;

b) a sensor module comprising of the following two sensor sub-modules;

i. a first sensor sub-module wherein the said 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 a mobile wearable computer or a PDA or a mobile phone, 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 an exercise apparatus such as a bicycle or a treadmill, in each of which case the first sensor sub-module communicates wirelessly with a mobile wearable computer, or a handheld communication device, or a PDA or a mobile phone using close range radiofrequency transmission, and,

ii. a second sensor sub-module wherein the said sensor is a software client server application that monitors user'"'"'s usage data regarding different functions of a mobile wearable computer, or a handheld communication device, or a PDA or a mobile phone, that is analyzed to provide the user'"'"'s free-living lifestyle that includes sleep patterns, physical activity or inactivity patterns, socializing patterns, mood patterns, and also to provide greater accuracy of accelerometer recordings 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 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 one or more of the said sensor modules can securely access and utilize for reference, inference, analysis, action and display;

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

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

g) a user health status dashboard GUI module, which displays user'"'"'s health indices in a form of distance traversed and calories burnt, and combines the said health indices with sensory module-measured lifestyle patterns 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 prescribed lifestyle goal achieved, morbidities reduced and prognosis improved, either on the display of the user device or via device or via an active server webpage accessed through a 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 confounding patterns of acceleration in X, Y and Z axes by using:

a) a perpendicular acceleration filter,

b) a gravity acceleration filter,

c) a reverse acceleration filter,

d) an orientation filter, and,

e) an anti-aliasing filter,

for filtering longitudinal acceleration data that does not confer with the said reference pattern of human stride stored in the said sensor data analysis module, such confounding patterns of acceleration result from motions that include alternate reverse velocity in a conventional treadmill walk, or a non-human stride motion such as high speed steady velocity of a vehicle ride or bike ride, or sporadic movements of the user'"'"'s hand 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 radiofrequency (RF) transponder module that detects RF signals from a synchronized RF transducer-equipped exercise equipment for allowing velocity metrics of exercise equipment based acceleration to 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 first four weeks, not less than 40,000 steps per week for next four weeks and 50,000 to 70,000 steps permanently thereafter, or not less than 500 MET (metabolic equivalents of task)-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 lifestyle 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 fruits, vegetables, nuts and legumes, whole grains and low-fat dairy products, and 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 individual device user, monitory benefits such as reduction in health insurance premium corresponding to levels lifestyle change achieved, and non-monetary rewards such as improved health, reduced morbidity and mortality risk, improved treatment prognosis, better patient-caregiver interaction, motivational messages and promotional offers;

b) to community, improved health status of population resulting in healthcare cost savings;

c) to caregiver and policy makers, a tool that disseminates and implements primary health care and prevention at all levels of healthcare; and

;

d) to payer or 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 initial and primary prescription limiting use of prescription drugs only to supplement the Rx Zero treatment until such time the prescription drugs are 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 improving prognosis.