WO2007095724A1

WO2007095724A1 - Medical cell/mobile phone for resource-limited settings and research settings

Info

Publication number: WO2007095724A1
Application number: PCT/CA2007/000237
Authority: WO
Inventors: Richard Lester
Original assignee: Richard Lester
Priority date: 2006-02-27
Filing date: 2007-02-16
Publication date: 2007-08-30

Abstract

A medical mobile/cell phone is for specific use by patients and clinical trials participants. It has important specific and restricted functionality beyond current cell phones in use. It allows a patient (or study participant) the ability to SMS text messages their care giver (or research coordinator), hereafter called the 'host', a specific set of clinical monitoring data, and can receive calls from the host's standard mobile phone, but cannot be used for making personal calls. The device is compact and easy to use regardless of literacy or language of the user. It has a limited set of preprogrammed SMS text messages triggered by buttons with easily recognizable symbols.

Description

MEDICAL CELL/MOBILE PHONE FOR RESOURCE-LIMITED SETTINGS AND RESEARCH SETTINGS

The present invention relates to a novel medical communication device suited to the needs of clinical monitoring of patients or participants of clinical trials

BACKGROUND OF THE INVENTION

Closely monitoring patients for treatment responses, side effects, and follow-up scheduling is critical to optimal care with many chronic disease conditions This is particularly felt in resource-limited healthcare settings where existing communication infrastructure is extremely limited Cell phone use is increasing in these settings, but important sectors of the population do not have access to cell phones due to cost and other considerations Providing standard cell phone can be expensive and open to abuse since they are designed for general use Despite this, public healthcare programs need to offer care to patients of wide geographic distribution and who have varied language and literacy backgrounds Examples include antiretroviral programs (ARV) for treatment of AIDS in low-income populations, seen extensively in Africa, and for directly observed therapy (DOT) programs for tuberculosis treatment Delays in reporting side effects to ARVs by patients can lead to worsened illness, stopping and restarting medications (adherence breaches) without medical consult can hasten ARV drug resistance, both with costly consequences In tuberculosis treatment programs, DOT involves a caregiver-witness to remind certain patients in the community to take their medications, and monitor that they took them for public health reasons Adherence breaches here can lead to drug resistance or persistence of the infection, and therefore transmissibility of the communicable disease Cell phone networks are expanding through regions encompassing populations with these epidemics

In addition, closely monitoring patients for clinical trials is important to detect responses and adverse events Simplifying the reporting system can improve participant compliance to the reporting protocol Additionally, decreasing delays in reporting can allow for more accurate data through reducing recall bias Regular cell phones are designed for use in the general population, which has different needs from the above A wireless cell phone device specifically aimed to the needs of monitoring patients in resource-limited settings has not previously existed Nor has the use of cell phones targeted to patient use in monitoring medical responses in clinical trials

US Patents 6,009,308 and 5,970,122 disclose cell or mobile phones arranged for calling a simplified set of preprogrammed numbers but not for preprogrammed text messaging WO 02/059417 (Kahn) published 25 July 2002 discloses a mobile phone where selected buttons provide predetermined text messages to be sent

However these devices are not suitable for the proposals disclosed herein Therefore, there exists the need for a targeted wireless communication device, not described in the prior art, to monitor patients in resource-limited settings and to more closely and conveniently monitor participants in clinical trials

The combined features of this Medical Mobile/Cell Phone will allow accomplishment of these needs better than any known prior device described in the art

SUMMARY OF THE INVENTION According to the invention there is provided a wireless network based cellular mobile phone device for use with a pre-selected host comprising a housing having an antenna, a series of control buttons, a display screen, a battery power supply, a microphone, a speaker and a control system for controlling incoming and outgoing calls, the control buttons and the control system being arranged such that the pressing of pre-programmed buttons by the user acts to send predetermined SMS text messages to the host, the control system being arranged such that it is restricted to receiving incoming "open" text messages or voice calls from a predetermined phone number established by the host, and the control buttons and the control system being arranged such that the device is restricted from sending outgoing open text messages or voice calls

Preferably the control buttons and the control system are arranged such that the device is prevented from sending outgoing open text messages or voice calls

Preferably the control buttons and the control system are arranged such that the device is allowed to send outgoing voice calls only to predetermined numbers Preferably the device can use SIM cards to allow usage of, and enrollment with, local networks in many locations around the world

Preferably there is provided a menu/confirm button to allow choices of functions and confirmation of data information to send

Preferably there is provided a face button with a healthcare symbol that sends a SMS message to the intended receiving host to request a "call back" reply

Preferably there is provided a plurality of buttons with symbols to indicate the SMS text message data that can be sent by pressing each button, where the buttons transmit coded data that is known and interpreted by the receiving host

Preferably one of the buttons has a pill symbol and signals to send data indicating that a certain medication was taken

Preferably one of the buttons indicates the said medication was not taken (missed) at that time Preferably one of the buttons indicates a predetermined "response" to treatment

Preferably one of the buttons indicates a side effect to treatment

Preferably one of the buttons indicates a flexible monitoring tool (data) Preferably the button symbols can be changed by exchangeable button face plates, as selected by the caregiver host's intended data collection

Preferably there is provided a clock and internal timer with an indicator light and sound for reminders to take medications or request data as per a protocol, where the light and/or sound is extinguished by pressing the corresponding button

Preferably a response is requested for the user to select one of the buttons to send a message

Preferably there is provided a keypad overlay which attaches to a base model cell phone without altering the existing phone Preferably there is provided a keypad exchange element which replaces the existing keypad and software from an existing phone, and replaces it with said control buttons

Preferably battery-life extension is obtained by slowing down scanning frequency overall and/or at certain hours to reduce battery draw According to a second aspect of the invention there is provided a method of monitoring patients in a health care system comprising providing a host station for communicating with a plurality of patients, providing for each patient a wireless network based cellular mobile phone device for use with a pre-selected host comprising a housing having antenna, a series of control buttons, a display screen, a battery power supply, a microphone, a speaker and a control system for controlling incoming and outgoing calls, the control buttons and the control system being arranged such that the pressing of pre-programmed buttons by the user acts to send predetermined SMS text messages to the host, the control system being arranged such that it is restricted to receiving incoming "open" text messages or voice calls from a predetermined phone number established by the host, and the control buttons and the control system being arranged such that the device is restricted from sending outgoing open text messages or voice calls, providing at the host station a telephone system for receiving the SMS text messages from the patients, and providing at the host station a recording system for recording the SMS text messages from the patients as data relating to the patients Thus there is provided a medical mobile/cell phone which is for specific use by patients and clinical trials participants It has important specific and restricted functionality beyond current cell phones in use It allows a patient (or study participant) the ability to SMS text messages their care giver (or research coordinator), hereafter called the "host", a specific set of clinical monitoring data, and can receive calls from the host's standard mobile phone, but cannot be used for making personal calls The device is compact and easy to use regardless of literacy or language of the user It has a limited set of preprogrammed SMS text messages triggered by buttons with easily recognizable symbols One of these buttons is a "call me" button, so that the caregiver host can call the patient back for a voice conversation if needed The other buttons send SMS text information that the caregiver host intends to monitor such as "took pills", or "side effect", and can be preprogrammed according to the information sought for monitoring by the host The button pad symbols are also exchangeable according to the monitored data selected The device uses SIM cards for connecting to a local network service provider The device is battery powered with maximal efficiency is and an energy saving sleep mode There is a secure identification tag on the unit with host contact information Several optional features include indicator light and sound reminders that can be extinguished by pushing the corresponding button, such as "took pills" or "did not take pills" Other options include spare iechargeable batteries and solar or manual charging devices for people without reliable access to electricity The medical mobile/cell phone is ideal for monitoring patients in treatment programs in resource-limited settings (such as AIDS or TB treatment programs) It is also ideal for monitoring participant data in clinical trials of all types Its restricted functionality make is unlikely to be sold or have unauthorized usage charges Its combination of versatility and restricted functionality features comprises a unique healthcare monitoring tool that can ideally help improve both patient care, and the quality of research in clinical trials

None have the prior art devices included the important restrictive functionality that prevents making general SMS texting or voice call-outs Such devices in the prior art are less practical for expanded healthcare programs This "preprogrammed-SMS text-out-only" restriction allows the phone to be used by patients in resource-limited settings without risk of unauthorized sale or unauthorized calling The device also requires the caregiver host to call to the device to activate voice communication This "call-back only feature" allows flexibility for the caregiver to respond at their convenience (and prevents phone call interruptions during clinical care), but still allows the necessary flexibility of discussing complex medical issues verbally with the patient

A medical mobile/cell phone is a novel type of cell phone that has specific and restricted functionality to allow a patient (or study participant) the ability to notify their care giver (or research coordinator) host instantly over a cell phone network a specific set of informative SMS (text messages) for monitoring purposes It cannot, however, be used for making personal calls The device is compact, transportable (mobile) and easy to use regardless of literacy or language of the user It has a limited set of preprogrammed text messages triggered by buttons with easily recognizable symbols The "call me" button sends an SMS text to the host's cell phone (which may be any standard phone, or modified according to the art and needs) requesting a call-back voice call The other buttons send SMS text-format information that the caregiver can monitor Preprogrammed SMS texts can be sent by pushing a corresponding button with a language independent symbol, such as "took pills", or "side effect" The message can be preprogrammed according to the monitoring wishes of the caregiver/researcher, and have exchangeable button pad with symbols to correspond with the message data

The medical mobile/cell phone device can use implantable SIM cards which can be programmed according to the local network service provider This allows flexibility for use in healthcare programs in a variety of countries and network coverage areas Messages sent from the device can be received by a standard host cell phone, and the patient device can receive SMS text messages or voice calls from a standard cell phone (when that corresponding number is enabled) The device is powered by rechargeable batteries Energy efficiency is maximized by the limited functionality of the device and a low energy "sleep" mode between uses A low battery indicator signal is switched on with 10% energy remaining to remind the user to charge the unit or switch batteries

In addition to the base unit, several optional features may be selected These include an indicator light and sound for reminders such as to take medications The light or is turned off by pushing the "took pills" or "did not take pills" automated SMS text buttons Other options include spare rechargeable batteries and hand winding or solar charging devices for people without reliable access to electricity There is a slot on the unit for an identification card with contact information of the owner (generally the health/research program provider)

The medical mobile/cell phone is ideal for monitoring patients in treatment programs in resource-limited settings (such as AIDS or TB treatment programs) because it allows almost instantaneous communication of important information which could otherwise be delayed by lack of existing communications infrastructure, or lack of access to it (such as prohibitive cost of owning/operating a standard cell phone), or require travel It is also ideal for research programs (such as clinical trials) as a monitoring aid that is flexible, but due to its restricted functionality, is unlikely to be sold or lead to unauthorized usage charges The Medical Mobile/Cell Phone therefore has a unique set of critical features, not previously compiled, that offers its use as a healthcare communication tool ideal for use in resource-limited settings, and in broad clinical trials

The device allows patients from a variety of language and literacy backgrounds to instantaneously send preprogrammed SMS text messages to their healthcare provider and to receive calls or text messages from that provider It has particular utility for global healthcare programs in resource-low settings or in broader clinical trials due to the flexibility of information it can transmit and its restricted functionality for prevention of unauthorized uses or sale Its uniqueness is in the essential simplicity of design overlooked by most of the advancing art in the telecommunications field for different uses BRIEF DISCRIPTION OF THE DRAWINGS

Figure 1 shows one embodiment of the base medical mobile/cell phone device according to the present invention

Figure 2 shows a number of optional features to the base unit of Figure 1 in concordance with its versatility Figure 3 shows a schematic of how the medical mobile/cell phone device of Figure 1 may be used in a networked healthcare setting DESCRIPTION OF THE PREFERED EMBODIMENT

A wireless network based cellular mobile phone device 21 is shown in Figure 1 that can send predetermined SMS text messages by pressing pre- programmed buttons 11 , and is restricted to receiving, but not sending, "open" text messages or voice calls from a predetermined phone number established by the host The above device uses a SIM card 1 to allow usage of and enrollment with, local networks in many locations around the world An antenna 2 allows transmission of cellular network signals An earpiece speaker 3 allows the user to receive voice calls A microphone 4 allows the user to respond to voice calls An audible speaker and/or vibration system 5 allows the user to be alerted to incoming calls or messages

A rechargeable battery 6 powers the device A switch 7 allows powering on and off of the device When the power is reduced to 10% a reminder battery indicator comes on

The face has an LCD screen 8 to indicate functions and receive SMS text messages

A menu/confirm button 9 is located at the edge of the LCD screen to allow choices of functions and confirmation of data information to send A face button 10 on the front of the device, with a healthcare symbol applied to the front of the button or adjacent the button, can be depressed by the user that acts to send a SMS message to the intended receiving host to request a "call back" reply

Several other large buttons 1 1 are provided on its face with symbols to indicate the SMS text message data that can be sent by pressing each button These buttons transmit coded data that is known and interpreted by the receiving host

For example, one of the buttons 11A has a pill symbol and signals to send data indicating that a certain medication was taken Another button 11 B if depressed by the user indicates by the message set to the host that the medication was not taken (missed) at that time

Another button indicates a predetermined "response" to treatment, eg button 1 Another button indicates a side effect to treatment, eg button 2

Another button indicates a flexible monitoring tool (data), eg button 3 The button symbols can be changed, by exchangeable button face plates, as selected by the caregiver host's intended data collection

The overall device casing is made of durable material and can be opened and resealed by the host provider for programming, SIM card placement, and change of button plates The casing has an identification plate 12 for adhering host contact information and/or emergency numbers in the event of loss of the device or device failure

Several optional features can be added, and would be expected with continued advancing of the art, for clinical monitoring and other expanded uses Examples of options as shown in Figure 2 include

Network connection ability in non-SIM card locations

Spare batteries and charging systems, such as hand winding or solar charging 13 units for use where a standard electrical power source is not reliably available A clock and internal timer 14 with an indicator light and sound for reminders to take medications or request data as per a protocol This light and/or sound is extinguished by pressing the corresponding button The indicator light may be on the side of the unit, or illuminate the specific button 15 to which a response is requested For example, the "took pill" and "did not take pill" buttons light up every 12 hours for b i d dosing, and are only extinguished when one of the buttons is pressed

A plurality of pre-determined call out numbers for voice calling 16 restricted to preprogrammed numbers and with buttons and symbols as with the SMS text buttons As shown in Figure 3 the device of Figures 1 and 2 is used in a system including a host health care provider For the caregiver to send and receive information from the patient/participant's medical mobile/cell phone, any standard cell phone on a compatible network would suffice However, the host may choose a phone that can store more phone numbers according to the number of patients/participants they intend to monitor (for example, for a phone that stores one thousand numbers, one of such phones can be used to monitor 1000 participants) The host may also choose a host cell phone platform that allows direct data filing and analysis via SMS text coding or SMS to email data transfer The caregiver/host is presumably not under the same cost and unauthorized used considerations as the patients or participants they monitor Most of the host mobile/cell phone hardware and software is currently available but would be expected to advance with the art

One option is that of a keypad that can be applied overtop of an existing cell phone to allow for the same simplified functionality as in the device as described above

In another option, some cell phones have a removable keypad that actually contains some of the software that runs the phones operations Thus a key pad can be manufactured for use with existing cell phones for purposes of recycling old phones with the new key pad and related software One option for modification of the software is to slow down the frequency of scanning for incoming calls or SMS texts This can greatly reduce battery draw if the frequent scanning is unnecessary for the application The primary effect would be to make the simplified cell phone for healthcare monitoring purposes as described above by using existing handset hardware as its base If the attachable key pad/software is also detachable for the user, then patients who require the simplified functionality could use the phone, but its full function could be restored by removing the overlaid keypad Full function may be desirable by some users sharing the phone There are large stockpiles of used phones, which could potentially be accessed and modified for our purposes Thus the following options can be considered

1 a simplified keypad overlay which attaches to base model cell phone without altering the existing phone This may be designed to work with multiple different handsets

2 a simplified keypad exchange which removes the existing keypad and software from phone, and replaces it with a simplified healthcare version according to the arrangements described herein It may be that the arrangement will need to be specific to existing phone types

3 battery-life extension which can be obtained by slowing down scanning frequency overall and/or at certain hours to reduce battery draw Since various modifications can be made in my invention as herein above described, and many apparently widely different embodiments of same made within the spirit and scope of the claims without department from such spirit and scope, it is intended that all matter contained in the accompanying specification shall be interpreted as illustrative only and not in a limiting sense

Claims

1 A wireless network based cellular mobile phone device for use with a pre-selected host comprising a housing having an antenna, a series of control buttons, a display screen, a battery power supply, a microphone, a speaker and a control system for controlling incoming and outgoing calls, the control buttons and the control system being arranged such that the pressing of pre-programmed buttons by the user acts to send predetermined SMS text messages to the host, the control system being arranged such that it is restricted to receiving incoming "open" text messages or voice calls from a predetermined phone number established by the host, and the control buttons and the control system being arranged such that the device is restricted from sending outgoing open text messages or voice calls

2 The device according to Claim 1 wherein the control buttons and the control system are arranged such that the device is prevented from sending outgoing open text messages or voice calls

3 The device according to any preceding claim wherein the control buttons and the control system are arranged such that the device is allowed to send outgoing voice calls only to predetermined numbers

4 The device according to any preceding claim wherein the device can use SIM cards to allow usage of, and enrollment with, local networks in many locations around the world 5 The device according to any preceding claim wherein there is provided a menu/confirm button to allow choices of functions and confirmation of data information to send

6 The device according to any preceding claim wherein there is provided a face button with a healthcare symbol that sends a SMS message to the intended receiving host to request a "call back" reply

7 The device according to any preceding claim wherein there is provided a plurality of buttons with symbols to indicate the SMS text message data that can be sent by pressing each button, where the buttons transmit coded data that is known and interpreted by the receiving host 8 The device according to any preceding claim wherein one of the buttons has a pill symbol and signals to send data indicating that a certain medication was taken

9 The device according to any preceding claim wherein one of the buttons indicates the said medication was not taken (missed) at that time 10 The device according to any preceding claim wherein one of the buttons indicates a predetermined "response" to treatment

1 1 The device according to any preceding claim wherein one of the buttons indicates a side effect to treatment

12 The device according to any preceding claim wherein one of the buttons indicates a flexible monitoring tool (data)

13 The device according to any preceding claim wherein the button symbols can be changed, by exchangeable button face plates, as selected by the caregiver host's intended data collection

14 The device according to any preceding claim wherein there is provided a clock and internal timer with an indicator light and sound for reminders to take medications or request data as per a protocol, where the light and/or sound is extinguished by pressing the corresponding button

15 The device according to Claim 14 wherein a response is requested for the user to select one of the buttons to send a message 16 The device according to any preceding claim wherein there is provided a keypad overlay which attaches to a base model cell phone without altering the existing phone

17 The device according to any preceding claim wherein there is provided a keypad exchange element which replaces the existing keypad and software from an existing phone, and replaces it with said control buttons

18 The device according to any preceding claim wherein battery- life extension is obtained by slowing down scanning frequency overall and/or at certain hours to reduce battery draw

19 A method of monitoring patients in a health care system comprising providing a host station for communicating with a plurality of patients, providing for each patient a wireless network based cellular mobile phone device for use with a pre-selected host comprising a housing having antenna, a series of control buttons, a display screen, a battery power supply, a microphone, a speaker and a control system for controlling incoming and outgoing calls, the control buttons and the control system being arranged such that the pressing of pre-programmed buttons by the user acts to send predetermined SMS text messages to the host, the control system being arranged such that it is restricted to receiving incoming "open" text messages or voice calls from a predetermined phone number established by the host, and the control buttons and the control system being arranged such that the device is restricted from sending outgoing open text messages or voice calls, providing at the host station a telephone system for receiving the SMS text messages from the patients, and providing at the host station a recording system for recording the SMS text messages from the patients as data relating to the patients 20 The method according to Claim 19 wherein there is provided on each mobile telephone device a face button that sends a SMS message to the intended receiving host to request a "call back" reply and arranging at the host station to call a patient on the mobile phone device of that patient when the message is received 21 The method according to Claim 19 or 20 wherein the control buttons and the control system on each mobile telephone device are arranged such that the device is prevented from sending outgoing open text messages or voice calls

22 The method according to any one of Claims 19 to 21 wherein the control buttons and the control system on each mobile telephone device are arranged such that the device is allowed to send outgoing voice calls only to predetermined numbers

23 The method according to any one of Claims 19 to 22 wherein each mobile telephone device can use SIM cards to allow usage of, and enrollment with, local networks in many locations around the world 24 The method according to any one of Claims 19 to 23 wherein on each mobile telephone device there is provided a menu/confirm button to allow choices of functions and confirmation of data information to send

25 The method according to any one of Claims 19 to 24 wherein on each mobile telephone device there is provided a face button with a healthcare symbol that sends a SMS message to the intended receiving host to request a "call back" reply

26 The method according to any one of Claims 19 to 25 wherein on each mobile telephone device there is provided a plurality of buttons with symbols to indicate the SMS text message data that can be sent by pressing each button, where the buttons transmit coded data that is known and interpreted by the receiving host

27 The method according to any one of Claims 19 to 26 wherein on each mobile telephone device one of the buttons has a pill symbol and signals to send data indicating that a certain medication was taken

28 The method according to any one of Claims 19 to 27 wherein on each mobile telephone device one of the buttons indicates the said medication was not taken (missed) at that time

29 The method according to any one of Claims 19 to 28 wherein on each mobile telephone device one of the buttons indicates a predetermined

"response" to treatment

30 The method according to any one of Claims 19 to 29 wherein on each mobile telephone device one of the buttons indicates a side effect to treatment 31 The method according to any one of Claims 19 to 30 wherein on each mobile telephone device one of the buttons indicates a flexible monitoring tool (data)

32 The method according to any one of Claims 19 to 31 including changing on each mobile telephone device the button symbols by exchangeable button face plates, as selected by the caregiver host's intended data collection

33 The method according to any one of Claims 19 to 32 wherein on each mobile telephone device there is provided a clock and internal timer with an indicator light and sound for reminders to take medications or request data as per a protocol, where the light and/or sound is extinguished by pressing the corresponding button

34 The method according to any one of Claims 19 to 33 wherein on each mobile telephone device when required a response is requested for the user to select one of the buttons to send a message

35 The method according to any one of Claims 19 to 34 including changing a keypad overlay which attaches to a base model cell phone without altering the existing phone

36 The method according to any one of Claims 19 to 35 including changing a keypad exchange element which replaces the existing keypad and software from an existing phone, and replaces it with said control buttons 37 The method according to any one of Claims 19 to 36 wherein battery-life extension is obtained by slowing down scanning frequency overall and/or at certain hours to reduce battery draw