System and method for monitoring efficacy of web-based online behavioral clinical study

• US 20040220833A1
• Filed: 04/13/2004
• Published: 11/04/2004
• Est. Priority Date: 04/15/2003
• Status: Abandoned Application

• Current Assignee: Smithkline Beecham Corporation (GSK plc)
• Original Assignee: Smithkline Beecham Corporation (GSK plc)
• Inventors: Matthias, Joseph A.
• Application Number:
  US10/823,114
• Publication Number:
  US 20040220833A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G09B 7/00 Electrically-operated teaching apparatus or devices working with questions and answers mechanically operated G09B3/00; computing arrangements G06F
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

A system and method which evaluates the efficacy of tailored online health related behavioral materials provided to a human subject. More particularly, a method of evaluating the efficacy of online behavioral material in a clinical study including enrolling a plurality of customers, performing a computerized initial, randomly segregating the plurality of customers into a first group which accesses tailored behavioral material online and a second group which accesses non-tailored behavioral material online, providing the first group with tailored behavioral material, providing the second group with non-tailored behavioral material, providing the first group and the second group with a computerized first and second series of questions, analyzing the responses of the first group and the second group to the first and second series of questions according to predetermined factors, and evaluating the efficacy of the behavioral material.

Claims

1. A method of evaluating the efficacy of online tailored behavioral material on human subjects comprising:

conducting a clinical study among human subjects, wherein the efficacy of the tailored behavioral materials on the human subjects is assessed through online remote interaction.

2. A method of evaluating the efficacy of online behavioral material in a clinical study comprising:

conducting an online clinical study among consumers; and

determining the efficacy of the behavioral material.

3. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 2, wherein conducting an online clinical study comprises:

enrolling a plurality of customers sufficiently meeting predetermined qualifying requirements for the online clinical study,

performing a computerized initial evaluation of a customer in order to obtain the customer'"'"'s particular characteristics wherein the initial evaluation is performed during a predetermined period of time in the beginning of the online clinical study, and within a predetermined time of the customers target quit date (TQD), wherein the initial evaluation assists in the tailoring behavioral material provided to a customer,

randomly segregating the plurality of customers into a first group which accesses tailored behavioral material online and a second group which accesses non-tailored behavioral material online,

providing the first group with behavioral material tailored to a particular customer'"'"'s characteristics wherein the customer reviews the available behavioral material online according to a predetermined plan,

providing the second group with non-tailored behavioral material generally determined to assist with the behavior under study,

providing the first group and the second group with a computerized first series of questions after a predetermined time in the study, wherein the first series of questions address the customer'"'"'s responses to the behavioral material which has been made available to the particular customer,

providing the first group and the second group with a computerized second series of questions after a predetermined time in the study after the first series of questions, wherein the second series of questions address the customer'"'"'s responses to the behavioral material which has been made available to the particular customer,

wherein determining the efficacy of the behavioral material comprises;

analyzing the responses of the first group and the second group to the first and second series of questions according to predetermined factors, and

evaluating the efficacy of the tailored online behavioral material with the non-tailored predetermined online information accordingly.

4. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, further comprising determining a period of time for initiation and termination of the online clinical study.

5. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, further comprising determining a quantity of customers desired for the online clinical study predetermined to be an effective quantity for assuring the accurateness of the clinical study.

6. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 2, wherein the customers have obtained medication which will assist in the behavior under study.

7. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein the qualifying requirements comprise a predetermined length of time as a smoker, gender, age and valid e-mail address.

8. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein said first and second series of questions assess smoking abstinence, program utilization and program satisfaction.

9. A method of evaluating the efficacy of online behavioral materials in a clinical study according to claim 3, wherein the initial evaluation and the first and second series of questions are collected using a web-based computer interface.

10. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein evaluating the efficacy of the tailored online smoking cessation materials is based on evaluating all of the customers in the study and based on the subjects using and accessing the website for the customer'"'"'s respective behavioral support material.

11. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein the customer is notified after a predetermined period of time that the customer can access the behavioral materials online.

12. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, further comprising providing the first group with periodic e-mails containing behavioral material tailored to the customer'"'"'s characteristics.

13. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, further comprising a constantly rolling enrollment period of customers for the clinical study until a predetermined number of customers for each group is met.

14. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein the customer enrolls for the clinical study through a website of a medical provider.

15. A method of evaluating the efficacy of online behavioral materials in a clinical study according to claim 3, wherein the first and second series of questions assess one or more of:

compliance with an appropriate use of the medication;

compliance with continual use of the medication;

the degree of personalization of the behavioral material;

the helpfulness of the behavioral material;

the customer'"'"'s satisfaction with the behavioral material; and

interest in participation in further studies.

16. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, further comprising providing compensation to the customer for participation in the clinical study, wherein the quantity of compensation is given according to length of time spent in the study while complying with the requirements of the study.

17. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein analyzing the responses comprises:

evaluating personal opinions indicated in the customers responses to the first and the second series of questions, regarding the effectiveness of the behavioral material.

18. A method of evaluating the efficacy of online behavioral material in a clinical study according to claim 3, wherein analyzing the responses comprises:

evaluating the effectiveness of the behavioral material according to a mathematical analysis based on smoking cessation rates reflected in the customers responses to the first and second series of questions.

19. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study comprising:

enrolling a plurality of customers sufficiently meeting predetermined requirements for the online clinical study,

performing a computerized initial evaluation of the customer'"'"'s in order to obtain the customer'"'"'s particular characteristics wherein the initial evaluation is performed during a predetermined period of time in the beginning of the online clinical study and within a predetermined time of the customer'"'"'s target quit date (TQD), wherein the TQD is the day designated by the customer for the quitting of smoking, wherein the initial evaluation assists in the tailoring of smoking cessation material provided to a customer

randomly segregating the plurality of customers into a first group which accesses tailored smoking cessation material online and a second group which accesses non-tailored smoking cessation material online,

providing the first group with smoking cessation material tailored to a particular customer'"'"'s characteristics wherein the customer reviews the available behavioral material online according to a predetermined plan,

providing the second group with non-tailored smoking cessation material generally determined to assist with smoking cessation,

providing the first group and the second group with a computerized first series of questions after a predetermined time in the study, wherein the first series of questions address the customer'"'"'s responses to the smoking cessation material which has been made available to the particular customer,

providing the first group and the second group with a computerized second series of questions after a predetermined time in the study after the first series of questions, wherein the second series of questions address the customer'"'"'s responses to the smoking cessation material which has been made available to the particular customer,

analyzing the responses of the first group and the second group to the first and second series of questions according to predetermined factors, and

evaluating the efficacy of the tailored online smoking cessation material with the non-tailored online smoking cessation material accordingly.

20. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, further comprising determining a period of time for initiation and termination of the online clinical study.

21. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, further comprising determining a quantity of customers desired for the online clinical study determined to be an effective quantity for assuring the accurateness of the clinical study.

22. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein the customers have obtained a smoking cessation medication which will assist in smoking cessation.

23. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein the qualifying requirements comprise a predetermined length of time as a smoker, gender, age and valid e-mail address.

24. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein said first and second series of questions assess smoking abstinence, program utilization and program satisfaction.

25. A method of evaluating the efficacy of online smoking cessation behavioral materials in a clinical study according to claim 19, wherein the initial evaluation and the first and second series of questions are collected using a web-based computer interface.

26. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein evaluating the efficacy of the tailored online smoking cessation materials is based on evaluating all of the customers in the study and based on the subjects using and accessing the website for the customer'"'"'s respective smoking cessation material.

27. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein the customer is notified after a predetermined period of time that the customer can access the smoking cessation material.

28. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, further comprising providing the first group with periodic E-mails containing smoking cessation material tailored to the customer'"'"'s characteristics.

29. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, further comprising a constantly rolling period of customers for the clinical study until a predetermined number of customers for each group is met.

30. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein the customer enrolls for the clinical study through a website of a medical provider.

31. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 22, wherein the first and second series of questions assess one or more of:

compliance with an appropriate use of the smoking cessation medication;

compliance with continual use of the smoking cessation medication;

the degree of personalization of the smoking cessation material;

the helpfulness of the smoking cessation material;

the customer'"'"'s satisfaction with the tailored behavioral materials; and

interest in participation in further studies.

32. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, further comprising providing compensation to the customer for participation in the clinical study, wherein the quantity of compensation is given according to length of time spent in the study while complying with the requirements of the study.

33. A method of evaluating the efficacy of online smoking cessation behavioral material in a clinical study according to claim 19, wherein analyzing the responses of the first group and the second group comprises:

evaluating the effectiveness of the behavioral material according to a mathematical analysis based on smoking cessation rates reflected in the customers responses in the first and second series of questions.

34. A system, for evaluating the efficacy of online behavioral material in a clinical study, comprising:

a website of a medical provider through which a customer registers for an online clinical study;

a customer computer, accessing the website of the medical provider;

a network connecting the host computer and the customer computer;

an automated education system of the medical provider, providing the customer with tailored behavioral material; and

an analyzing mechanism which evaluates the efficacy of the behavioral materials according to information input by a customer computer.

35. A system, for evaluating the efficacy of online smoking cessation behavioral material in a clinical study, according to claim 34, wherein said behavioral material comprises smoking cessation material.