HeadacheNCT00746408
Tailored Internet Information Supply for Patients
An observational study of Headache, run by Health & Life Sciences University, Tryol at 1 site in Austria.
Trial summary
Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Expert system guided tailored information
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All German speaking adults in the German-speaking part of Europe who suffer at least occasionally from headaches and have not been examined (concerning these headaches) by a physician yet. * The population of the main study is narrowed down to a heterogeneous group of insurants of a health insurance company. * The population of the online study is self-selecting.
Who may be able to join
- Age between 18 and 75
- Suffers at least occasionally from headaches
- Has internet access
- Has not obtained a medical diagnosis (concerning this headache) by a physician, yet
Who cannot join
- Age under 18
- Age over 75
- Does never suffer from headaches
- Has no internet access
- Has already gotten a medical diagnosis for her/his headaches
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Health & Life Sciences University (UMIT)
Hall in Tyrol, Tyrol, 6060
Wilfried Honekamp, MSc & Dipl.-Inform., +49 (0) 178 1604553, wilfried.honekamp@umit.at
Wilfried Honekamp, MSc & Dipl.-Inform.
About this study
Official title: Study of the Quality of Self-Diagnosis by Headache Patients Getting Tailored Internet Information
Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.
- Conditions
- Headache
- Being tested
- Expert system guided tailored information
- Keywords
- Internet, Information supply, Tailoring, Patient empowerment, Headaches, Consumer Health Information, Information Services, Information Storage and Retrieval, Information Systems
- Medical subject headings
- Headache, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert system guided tailored informationOther
The prototype is realised by a web-based information system. The HTML web-interface guides the user through the search process by querying the information demand. This is done by an integrated expert system. The expert system uses a rule based inference to determine an internal diagnosis. Based on this internal diagnosis the system searches quality labeled websites and presents relevant information to the user.
| Study group | Role | What they receive |
|---|---|---|
| Main 1 | Insurants of the health insurance company BARMER using the prototype to receive expert system guided tailored internet information about the type of headache they suffer from. Receives: Other: Expert system guided tailored information | |
| Main 2 | Insurants of the health insurance company BARMER using search engines and portals to gather internet information about the type of headache they suffer from. | |
| Online 1 | Internet users using the prototype to receive expert system guided tailored internet information about the type of headache they suffer from. Receives: Other: Expert system guided tailored information | |
| Online 2 | Internet users using search engines and portals to gather internet information about the type of headache they suffer from. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conformity of self-diagnosis and medical diagnosis
Measured: After medical diagnoses has been received
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health & Life Sciences University, Tryol
- Sponsor type
- University, hospital or other
- Collaborators
- Bremen University of Applied Sciences
- Investigators
- Wilfried Honekamp, MSc & Dipl.-Inform., Principal investigator, Health & Life Sciences University Tyrol, AustriaHerwig Ostermann, Dr., Study director, Health & Life Sciences University Tyrol, AustriaRoland Staudinger, Prof., Study chair, Health & Life Sciences University Tyrol, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746408
- Sponsor's protocol ID
- GW Diss 3000490
- Status last verified
- Jun 2009
- First submitted
- 2 Sep 2008
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eysenbach G, Powell J, Kuss O, Sa ER. Empirical studies assessing the quality of health information for consumers on the world wide web: a systematic review. JAMA. 2002 May 22-29;287(20):2691-700. doi: 10.1001/jama.287.20.2691.
PubMed 12020305Andrew ME, Penzien DB, Rains JC, Knowlton GE, McAnulty RD. Development of a computer application for headache diagnosis: the Headache Diagnostic System. Int J Biomed Comput. 1992 Jul;31(1):17-24. doi: 10.1016/0020-7101(92)90050-3.
PubMed 1644498Baur C, Deering MJ. Proposed frameworks to improve the quality of health web sites: review. MedGenMed. 2000 Sep 26;2(3):E35. No abstract available.
PubMed 11104481Bessell TL, McDonald S, Silagy CA, Anderson JN, Hiller JE, Sansom LN. Do Internet interventions for consumers cause more harm than good? A systematic review. Health Expect. 2002 Mar;5(1):28-37. doi: 10.1046/j.1369-6513.2002.00156.x.
PubMed 11906539Bindels R, Winkens RA, van Wersch JW, Pop P, Hasman A. Comparing assessment of appropriateness of diagnostic tests between a human expert and an automated reminder system. Stud Health Technol Inform. 2000;77:239-43.
PubMed 11187550Birru MS, Monaco VM, Charles L, Drew H, Njie V, Bierria T, Detlefsen E, Steinman RA. Internet usage by low-literacy adults seeking health information: an observational analysis. J Med Internet Res. 2004 Sep 3;6(3):e25. doi: 10.2196/jmir.6.3.e25.
PubMed 15471751Buchanan BG, Moore JD, Forsythe DE, Carenini G, Ohlsson S, Banks G. An intelligent interactive system for delivering individualized information to patients. Artif Intell Med. 1995 Apr;7(2):117-54. doi: 10.1016/0933-3657(94)00029-r.
PubMed 7647838Bull FC, Kreuter MW, Scharff DP. Effects of tailored, personalized and general health messages on physical activity. Patient Educ Couns. 1999 Feb;36(2):181-92. doi: 10.1016/s0738-3991(98)00134-7.
PubMed 10223022Eysenbach G, Kohler C, Yihune G, Lampe K, Cross P, Brickley D. A metadata vocabulary for self- and third-party labeling of health web-sites: Health Information Disclosure, Description and Evaluation Language (HIDDEL). Proc AMIA Symp. 2001:169-73.
PubMed 11825174Gagliardi A, Jadad AR. Examination of instruments used to rate quality of health information on the internet: chronicle of a voyage with an unclear destination. BMJ. 2002 Mar 9;324(7337):569-73. doi: 10.1136/bmj.324.7337.569.
PubMed 11884320Jadad AR, Gagliardi A. Rating health information on the Internet: navigating to knowledge or to Babel? JAMA. 1998 Feb 25;279(8):611-4. doi: 10.1001/jama.279.8.611.
PubMed 9486757Kopec D, Shagas G, Selman J, Reinharth D, Tamang S. Development of an expert system for differentiating tension type headaches from migraines. Stud Health Technol Inform. 2004;103:81-92.
PubMed 15747909Norman CD, Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked World. J Med Internet Res. 2006 Jun 16;8(2):e9. doi: 10.2196/jmir.8.2.e9.
PubMed 16867972Olesen J. The International Classification of Headache Disorders. Headache. 2008 May;48(5):691-3. doi: 10.1111/j.1526-4610.2008.01121.x.
PubMed 18471112Olesen J. International Classification of Headache Disorders, Second Edition (ICHD-2): current status and future revisions. Cephalalgia. 2006 Dec;26(12):1409-10. doi: 10.1111/j.1468-2982.2006.01214.x. No abstract available.
PubMed 17116090
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Quality of Self-Diagnosis by Headache Patients Getting Tailored Internet Information
- ClinicalTrials.gov ID
- NCT00746408
- Acronym / sponsor ID
- GW Diss 3000490
- Conditions
- Headache
- Keywords
- Internet, Information supply, Tailoring, Patient empowerment, Headaches, Consumer Health Information, Information Services, Information Storage and Retrieval
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Health & Life Sciences University, TryolUniversity, hospital or other
- Collaborators
- Bremen University of Applied Sciences
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Main 1 | – | Other: Expert system guided tailored informationInsurants of the health insurance company BARMER using the prototype to receive expert system guided tailored internet information about the type of headache they suffer from. |
| Main 2 | – | –Insurants of the health insurance company BARMER using search engines and portals to gather internet information about the type of headache they suffer from. |
| Online 1 | – | Other: Expert system guided tailored informationInternet users using the prototype to receive expert system guided tailored internet information about the type of headache they suffer from. |
| Online 2 | – | –Internet users using search engines and portals to gather internet information about the type of headache they suffer from. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All German speaking adults in the German-speaking part of Europe who suffer at least occasionally from headaches and have not been examined (concerning these headaches) by a physician yet. * The population of the main study is narrowed down to a heterogeneous group of insurants of a health insurance company. * The population of the online study is self-selecting.
Key inclusion criteria (4 listed)
- Age between 18 and 75
- Suffers at least occasionally from headaches
- Has internet access
- Has not obtained a medical diagnosis (concerning this headache) by a physician, yet
Key exclusion criteria (5 listed)
- Age under 18
- Age over 75
- Does never suffer from headaches
- Has no internet access
- Has already gotten a medical diagnosis for her/his headaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert system guided tailored informationThe prototype is realised by a web-based information system. The HTML web-interface guides the user through the search process by querying the information demand. This is done by an integrated expert system. The expert system uses a rule based inference to determine an internal diagnosis. Based on this internal diagnosis the system searches quality labeled websites and presents relevant information to the user. | Other | Main 1, Online 1 |
Primary outcome
Conformity of self-diagnosis and medical diagnosis
Time frame: After medical diagnoses has been received
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
- Background: PubMed 12020305Eysenbach G, Powell J, Kuss O, Sa ER. Empirical studies assessing the quality of health information for consumers on the world wide web: a systematic review. JAMA. 2002 May 22-29;287(20):2691-700. doi: 10.1001/jama.287.20.2691.
- Background: PubMed 1644498Andrew ME, Penzien DB, Rains JC, Knowlton GE, McAnulty RD. Development of a computer application for headache diagnosis: the Headache Diagnostic System. Int J Biomed Comput. 1992 Jul;31(1):17-24. doi: 10.1016/0020-7101(92)90050-3.
- Background: PubMed 11104481Baur C, Deering MJ. Proposed frameworks to improve the quality of health web sites: review. MedGenMed. 2000 Sep 26;2(3):E35. No abstract available.
- Background: PubMed 11906539Bessell TL, McDonald S, Silagy CA, Anderson JN, Hiller JE, Sansom LN. Do Internet interventions for consumers cause more harm than good? A systematic review. Health Expect. 2002 Mar;5(1):28-37. doi: 10.1046/j.1369-6513.2002.00156.x.
- Background: PubMed 11187550Bindels R, Winkens RA, van Wersch JW, Pop P, Hasman A. Comparing assessment of appropriateness of diagnostic tests between a human expert and an automated reminder system. Stud Health Technol Inform. 2000;77:239-43.
- Background: PubMed 15471751Birru MS, Monaco VM, Charles L, Drew H, Njie V, Bierria T, Detlefsen E, Steinman RA. Internet usage by low-literacy adults seeking health information: an observational analysis. J Med Internet Res. 2004 Sep 3;6(3):e25. doi: 10.2196/jmir.6.3.e25.
- Background: PubMed 7647838Buchanan BG, Moore JD, Forsythe DE, Carenini G, Ohlsson S, Banks G. An intelligent interactive system for delivering individualized information to patients. Artif Intell Med. 1995 Apr;7(2):117-54. doi: 10.1016/0933-3657(94)00029-r.
- Background: PubMed 10223022Bull FC, Kreuter MW, Scharff DP. Effects of tailored, personalized and general health messages on physical activity. Patient Educ Couns. 1999 Feb;36(2):181-92. doi: 10.1016/s0738-3991(98)00134-7.
- Background: PubMed 11825174Eysenbach G, Kohler C, Yihune G, Lampe K, Cross P, Brickley D. A metadata vocabulary for self- and third-party labeling of health web-sites: Health Information Disclosure, Description and Evaluation Language (HIDDEL). Proc AMIA Symp. 2001:169-73.
- Background: PubMed 11884320Gagliardi A, Jadad AR. Examination of instruments used to rate quality of health information on the internet: chronicle of a voyage with an unclear destination. BMJ. 2002 Mar 9;324(7337):569-73. doi: 10.1136/bmj.324.7337.569.
- Background: PubMed 9486757Jadad AR, Gagliardi A. Rating health information on the Internet: navigating to knowledge or to Babel? JAMA. 1998 Feb 25;279(8):611-4. doi: 10.1001/jama.279.8.611.
- Background: PubMed 15747909Kopec D, Shagas G, Selman J, Reinharth D, Tamang S. Development of an expert system for differentiating tension type headaches from migraines. Stud Health Technol Inform. 2004;103:81-92.
- The study websiteLink provided by the sponsor.
- University of Applied Sciences Bremen, GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried Honekamp, MSc & Dipl.-Inform. principal investigator
Health & Life Sciences University Tyrol, Austria
Herwig Ostermann, Dr. study director
Health & Life Sciences University Tyrol, Austria
Roland Staudinger, Prof. study chair
Health & Life Sciences University Tyrol, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Health & Life Sciences University, Tryol at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfried Honekamp, MSc & Dipl.-Inform. (+49 (0) 178 1604553, wilfried.honekamp@umit.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conformity of self-diagnosis and medical diagnosis (time frame: After medical diagnoses has been received). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00746408, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2009.