Method of monitoring patient participation in a clinical study

• US 20050182664A1
• Filed: 10/28/2004
• Published: 08/18/2005
• Est. Priority Date: 02/18/2004
• Status: Abandoned Application

• Current Assignee: Siemens AG
• Original Assignee: Siemens AG
• Inventors: Abraham-Fuchs, Klaus, Schmidt, Markus, Rumpel, Eva, Schneider, Siegfried, Schreiner, Horst, Kuth, Rainer, Zahlmann, Gudrun
• Application Number:
  US10/975,056
• Publication Number:
  US 20050182664A1
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

A method is proposed for monitoring participation of a patient in at least one clinical trial. The method includes collecting data regarding at least one clinical trial for the patient. Using a computer device, the collected data is then compared to at least one threshold. Finally, the patient is rewarded upon the collected data at least meeting at least one threshold.

Claims

1. A method of monitoring participation of a patient in at least one clinical trial, comprising:

collecting data regarding at least one clinical trial for the patient;

comparing, using a computer device, the collected data to at least one threshold; and

rewarding the patient upon the collected data at least meeting at least one threshold.

2. The method of claim 1, wherein the collected data is compared to a plurality of thresholds and wherein the patient is rewarded each time the collected data exceeds one of the plurality of thresholds.

3. The method of claim 2, wherein the at least one threshold is determined based upon criteria of the at least one clinical trial.

4. The method of claim 1, wherein the at least one threshold is determined based upon criteria of the at least one clinical trial.

5. The method of claim 1, wherein the comparing of the collected data to a threshold relates to compliance, by the patient, of at least one criterion of the at least one clinical trial.

6. The method of claim 5, wherein the at least one criterion includes timeliness.

7. The method of claim 5, wherein the at least one criterion includes at least one qualitative measure.

8. The method of claim 5, wherein the at least one criterion includes at least one quantitative measure.

9. The method of claim 5, wherein the at least one criterion includes at least one protocol requirement of the at least one clinical trial.

10. The method of claim 1, wherein the plurality of thresholds are weighted and wherein the rewarded is weighted relative to the threshold.

11. The method of claim 1, wherein the rewarding includes rewarding points.

12. The method of claim 11, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

13. The method of claim 10, wherein the rewarding includes rewarding points.

14. The method of claim 13, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

15. The method of claim 1, wherein the method further includes penalizing upon the collected data failing to meet at least at least one threshold.

16. The method of claim 11, wherein the method further includes penalizing upon the collected data failing to meet at least at least one threshold.

17. The method of claim 16, wherein the penalizing includes a reduction in points.

18. The method of claim 11, wherein the points are stored in a storage device.

19. The method of claim 13, wherein the points are stored in a storage device.

20. The method of claim 17, wherein the points are stored in a storage device.

21. The method of claim 1, wherein the data is collected from at least one external database.

22. The method of claim 1, wherein the data is collected from at least one external device used by the patient.

23. The method of claim 21, wherein the data is collected from at least one external device used by the patient.

64. The method of claim 1, wherein the collected data is stored in a memory.

65. The method of claim 1, wherein the comparing further includes comparing the collected data to at least one threshold of acceptability.

66. The method of claim 5, wherein the criteria includes quality and performance parameters.

67. A device for implementing the method of claim 1.

70. A program, adapted to perform the method of claim 1, when executed on a computer device.

71. A computer readable medium, storing the program of claim 70.

24. A method of monitoring participation of a patient in at least one clinical trial, comprising:

collecting data regarding at least one clinical trial for the patient;

determining, using a computer device, whether or not the patient has complied with at least one criterion of the at least one clinical trial, from the collected data; and

rewarding the patient upon determining that the patient has complied with at least one criterion of the at least one clinical trial.

25. The method of claim 24, wherein the at least one criterion includes timeliness.

26. The method of claim 24, wherein the at least one criterion includes at least one qualitative measure.

27. The method of claim 24, wherein the at least one criterion includes at least one quantitative measure.

28. The method of claim 24, wherein the at least one criterion includes at least one protocol requirement of the at least one clinical trial.

29. The method of claim 24, wherein the collected data is compared to a plurality of criteria and wherein the patient is rewarded each time it is determined that the patient has complied with one of the plurality of criteria.

30. The method of claim 29, wherein the plurality of criteria are weighted and wherein the rewarded is weighted relative to the criterion.

31. The method of claim 24, wherein the rewarding includes rewarding points.

32. The method of claim 31, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

33. The method of claim 30, wherein the rewarding includes rewarding points.

34. The method of claim 33, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

35. The method of claim 24, wherein the method further includes penalizing upon the collected data failing to meet at least at least one threshold.

36. The method of claim 31, wherein the method further includes penalizing upon determining that the patient has failed to comply with the at least one criterion of the clinical trial.

37. The method of claim 36, wherein the penalizing includes a reduction in points.

38. The method of claim 31, wherein the points are stored in a storage device.

39. The method of claim 33, wherein the points are stored in a storage device.

40. The method of claim 37, wherein the points are stored in a storage device.

41. The method of claim 24, wherein the data is collected from at least one external database.

42. The method of claim 24, wherein the data is collected from at least one external device used by the patient.

43. The method of claim 41, wherein the data is collected from at least one external device used by the patient.

68. A device for implementing the method of claim 24.

72. A program, adapted to perform the method of claim 24, when executed on a computer device.

73. A computer readable medium, storing the program of claim 72.

44. A method of monitoring participation of a patient in at least one clinical trial, comprising:

collecting data regarding at least one clinical trial for the patient;

determining, using a computer device, whether or not the patient has complied with at least one criterion of the at least one clinical trial; and

indicating that the patient is entitled to compensation upon determining that the patient has complied with at least one criterion of the at least one clinical trial.

45. The method of claim 44, wherein the at least one criterion includes timeliness.

46. The method of claim 44, wherein the at least one criterion includes at least one qualitative measure.

47. The method of claim 44, wherein the at least one criterion includes at least one quantitative measure.

48. The method of claim 44, wherein the at least one criterion includes at least one protocol requirement of the at least one clinical trial.

49. The method of claim 44, wherein the determination is made for compliance of a plurality of criteria and wherein it is indicated that the patient is entitled to compensation each time it is determined that the patient has complied with one of the plurality of criteria.

50. The method of claim 49, wherein the plurality of criteria are weighted and wherein the compensation is weighted relative to the criterion.

51. The method of claim 44, wherein the indicating includes awarding points.

52. The method of claim 51, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

53. The method of claim 50, wherein the indicating includes awarding points.

54. The method of claim 53, wherein the points are redeemable for at least one of a financial benefit, a medical treatment benefit, a medical drug benefit, an additional diagnostic procedure not normally covered by insurances, a visit to a physician, and a discount.

55. The method of claim 44, wherein the method further includes penalizing upon the collected data failing to meet at least at least one threshold.

56. The method of claim 51, wherein the method further includes penalizing upon determining that the patient has failed to comply with the at least one criterion of the clinical trial.

57. The method of claim 56, wherein the penalizing includes a reduction in points.

58. The method of claim 51, wherein the points are stored in a storage device.

59. The method of claim 53, wherein the points are stored in a storage device.

60. The method of claim 57, wherein the points are stored in a storage device.

61. The method of claim 44, wherein the data is collected from at least one external database.

62. The method of claim 44, wherein the data is collected from at least one external device used by the patient.

63. The method of claim 61, wherein the data is collected from at least one external device used by the patient.

69. A device for implementing the method of claim 44.

74. A program, adapted to perform the method of claim 44, when executed on a computer device.

75. A computer readable medium, storing the program of claim 75.

76. An apparatus for monitoring participation of a patient in at least one clinical trial, comprising:

means for collecting data regarding at least one clinical trial for the patient from an external device;

means for comparing the collected data to at least one threshold; and

means for rewarding the patient upon the collected data at least meeting at least one threshold.

77. The apparatus of claim 76, wherein the collected data is compared to a plurality of thresholds and wherein the patient is rewarded each time the collected data exceeds one of the plurality of thresholds.

78. The apparatus of claim 76, wherein the at least one threshold is determined based upon criteria of the at least one clinical trial.

79. The apparatus of claim 76, wherein the comparing of the collected data to a threshold relates to compliance, by the patient, of at least one criterion of the at least one clinical trial.

80. The apparatus of claim 77, wherein the plurality of thresholds are weighted and wherein the rewarded is weighted relative to the threshold.

81. The apparatus of claim 76, wherein the rewarding includes rewarding points.

82. The apparatus of claim 81, wherein the points are stored in a storage device.

83. The apparatus of claim 76, wherein the at least one external device includes at least one of at least one external database and at least one external device used by the patient.

84. An apparatus for monitoring participation of a patient in at least one clinical trial, comprising:

means for collecting data regarding at least one clinical trial for the patient from at least one external device;

means for determining whether or not the patient has complied with at least one criterion of the at least one clinical trial, from the collected data; and

means for rewarding the patient upon determining that the patient has complied with at least one criterion of the at least one clinical trial.

85. The apparatus of claim 84, wherein the collected data is compared to a plurality of thresholds and wherein the patient is rewarded each time the collected data exceeds one of the plurality of thresholds.

86. The apparatus of claim 84, wherein the at least one threshold is determined based upon criteria of the at least one clinical trial.

87. The apparatus of claim 84, wherein the comparing of the collected data to a threshold relates to compliance, by the patient, of at least one criterion of the at least one clinical trial.

88. The apparatus of claim 85, wherein the plurality of thresholds are weighted and wherein the rewarded is weighted relative to the threshold.

89. The apparatus of claim 84, wherein the rewarding includes rewarding points.

90. The apparatus of claim 89, wherein the points are stored in a storage device.

91. The apparatus of claim 84, wherein the at least one external device includes at least one of at least one external database and at least one external device used by the patient.

92. An apparatus for monitoring participation of a patient in at least one clinical trial, comprising:

means for collecting data regarding at least one clinical trial for the patient from at least one external device;

means for determining whether or not the patient has complied with at least one criterion of the at least one clinical trial; and

means for indicating that the patient is entitled to compensation upon determining that the patient has complied with at least one criterion of the at least one clinical trial.

93. The apparatus of claim 92, wherein the collected data is compared to a plurality of thresholds and wherein the patient is rewarded each time the collected data exceeds one of the plurality of thresholds.

94. The apparatus of claim 93, wherein the plurality of thresholds are determined based upon criteria of the at least one clinical trial.

95. The apparatus of claim 93, wherein the plurality of thresholds are weighted and wherein the rewarded is weighted relative to the threshold.

96. The apparatus of claim 92, wherein the indicating includes rewarding points.

97. The apparatus of claim 96, wherein the points are stored in a storage device.

98. The apparatus of claim 92, wherein the at least one external device includes at least one of at least one external database and at least one external device used by the patient.