Type 2 DiabetesiADAPTNCT01493258
Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination
A study testing iCOPE Intervention group in people with Type 2 Diabetes, run by Johns Hopkins University at 3 sites in United States.
Trial summary
In this project the investigators seek to utilize our experience for developing a comprehensive informatics framework for rapid adaptation and dissemination of Comparative Effectiveness Research (CER) products tailored to different categories of health consumers including difficult-to-reach patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- iCOPE Intervention group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to not given
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have clinical diagnosis of Type 2 diabetes;
- take oral diabetes medications;
- be 65 years of age or older at the time of randomization;
- plan to remain in the Maryland/DC area until the completion of the study follow-up;
- understand English at the 5th grade level.
Who cannot join
- plan to leave Maryland/DC area before the completion of the study follow- up;
- presence of significant cognitive impairment based on a Mini-Mental State Examination (MMSE) score ≤23
- do not speak English.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins University
Baltimore, Maryland, 21224
About this study
In this project the investigators seek to utilize our experience for developing a comprehensive informatics framework for rapid adaptation and dissemination of Comparative Effectiveness Research (CER) products tailored to different categories of health consumers including difficult-to-reach patients. Based on our previous successful experience in computer-assisted education, the investigators will refine the current CO-ED platform to implement and test a novel system for individualized continuous patient education (iCOPE). The iCOPE platform will be specifically designed to support rapid adaptation, customization, and dissemination of the CER products to the difficult-to-reach populations. The iCOPE platform will implement universal means for customized delivery of CER information in the format of interactive self-paced educational modules, quick "question \& answer" guides, and interactive decision aids. In addition, the iCOPE platform will support the innovative concept of continuous patient health education by providing patients with easy access to the interactive CER updates via web, MP3 players and phone-based interactive voice response (IVR) technology. Though iCOPE will be designed to support the whole spectrum of CER products, in this project the investigators will focus on the Comparative Effectiveness Research Summary Guide (CERSG) entitled "Pills for Type 2 Diabetes."
The following primary hypothesis will be tested in the RCT: Use of the iCOPE platform will be associated with improvement in CERSG knowledge in elderly at 6 months after the intervention.
The investigators will also examine the impact of iCOPE on medication adherence self-efficacy, diabetes medication satisfaction, HbA1c, and CERSG acceptance.
Read the detailed description
Interactive, computer-based education has the potential to greatly increase interest, because the learner actively participates in the learning process (Fox, 2009). In addition, the involvement of auditory, visual, and interactive learning strategies can increase recall of information. Computer-assisted educational programs may incorporate features that promote ease of use, be written in multiple languages, be scripted at a level that addresses the needs of low literacy learners, and be viewed as often as needed by a patient (Fox, 2009).
Several studies reported results of using computer technology in educating elderly patients about health conditions. Stromberg et al (2006) used a single-session, interactive computer-based educational program about chronic heart failure in elderly patients. They demonstrated that interactive computer-mediated education may be effectively used to increase patients' knowledge, about heart failure. Another study, conducted by Lin et al (2009), evaluated the usability of a touch-screen-enabled personal education program (PEP). The results showed that the system was evaluated as usable and useful, and older adults were satisfied with their experience. Similar findings were reported by Neafsey et al (2008) who also evaluated a patient-centered computer-mediated program using touch screen computers. Authors reported high satisfaction of the older adult users, increased knowledge and self-efficacy for avoiding adverse self-medication behaviors.
Elderly patients are less likely than younger patients to seek incidental information on their condition via internet. (Tian \& Robinson, 2008) Elderly patients therefore are less likely to navigate internet looking for information about evidence or treatment guidelines for their conditions. More targeted efforts may be needed to reach such populations. Disseminating information via combination of high technology media along with traditional media that are easily usable is helpful (Longo, 2005). A recent review of barriers and drivers of health IT use by elderly, very ill, and underserved, revealed that such technology can play a role in offering effective interventions. The consumer perceptions on benefits from use of system, convenience of use, and familiar technology were all important factors for intervention success (Jimison et al., 2008).
- Conditions
- Type 2 Diabetes
- Being tested
- iCOPE Intervention group
- Keywords
- Diabetes, Comparative Effectiveness Research, Interactive computer-assisted education, Informatics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCOPE Intervention groupOther
The study participants in the intervention group will use iCOPE platform providing adapted CERSG content in an interactive and tailored way. The intervention provided by the iCOPE platform will be implemented with the understanding that it should be user-friendly and not time consuming. Initially, all participants will be asked to complete the computer-mediated interactive CERSG module via touch screen tablet PC provided at hospital, in a primary care office, and in senior centers. The total time to complete the curriculum is about 30 min, however the patients will be able to distribute this time throughout a day at their convenience. Once the educational curriculum is completed, the intervention subjects will receive access to other components of the iCOPE platform.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The study participants randomized to the Group 2 will serve as a control. At the beginning of the study, they will receive a CERSG brochure printed from the AHRQ site. They will be asked to study it to the best of their ability throughout the day. |
| iCOPE Intervention group | Experimental | iCOPE intervention group will receive a CERSG brochure via the iCOPE system. Receives: Other: iCOPE Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CERSG Knowledge Score from baseline to 24-hr and to 6-month follow up
CERSG Knowledge Score will be used to assess the overall patient knowledge of the information provided in the CERSG entitled "Pills for Type 2 Diabetes." The score will represent a percentage of correct answers to 30 true/false items designed in accordance with the content of the CERSG.
Measured: The Knowledge Test will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
Secondary outcomes (4)
Medication adherence self-efficacy
Medication adherence self-efficacy will measure self-efficacy of taking medications.
Measured: The medication adherence self-efficacy measure will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
Diabetes Medication Satisfaction
Diabetes Medication Satisfaction measure is a diabetes-specific measure, assessing medication treatment satisfaction in three domains: Efficacy, Burden, Symptoms (Side Effects).
Measured: Diabetes medication satisfaction measure will be administered at the baseline and at the 6-month follow-up.
Glucosylated hemoglobin (HbA1c)
Glucosylated hemoglobin (HbA1c) will be obtained from Electronic Medical Record (Centricity) at Johns Hopkins Community Physicians (JHCP).
Measured: Glucosylated hemoglobin (HbA1c) values will be obtained closest to the date of the baseline evaluation and 6-month follow-up.
CERSG Acceptance
CERSG acceptance will measure patient acceptance and comprehension of CERSG
Measured: The CERSG acceptance measure will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startAug 2010
Why it stopped: PI left JHU and is not able to be reached for updates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Finkelstein, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493258
- Sponsor's protocol ID
- NA_00040442
- Acronym
- iADAPT
- Status last verified
- May 2019
- First submitted
- 9 Dec 2011
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data contain sensitive information
Publications
Tian Y, Robinson JD. Incidental health information use and media complementarity: a comparison of senior and non-senior cancer patients. Patient Educ Couns. 2008 Jun;71(3):340-4. doi: 10.1016/j.pec.2008.02.006. Epub 2008 Mar 26.
PubMed 18372141Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.
PubMed 19047879Longo DR. Understanding health information, communication, and information seeking of patients and consumers: a comprehensive and integrated model. Health Expect. 2005 Sep;8(3):189-94. doi: 10.1111/j.1369-7625.2005.00339.x. No abstract available.
PubMed 16098149Jimison H, Gorman P, Woods S, Nygren P, Walker M, Norris S, Hersh W. Barriers and drivers of health information technology use for the elderly, chronically ill, and underserved. Evid Rep Technol Assess (Full Rep). 2008 Nov;(175):1-1422.
PubMed 19408968Lapshin OV, Sharma K, Finkelstein J. Depression education for primary care patients using a web-based program. AMIA Annu Symp Proc. 2005;2005:1017. No abstract available.
PubMed 16779304Finkelstein J, Lapshin O. Reducing depression stigma using a web-based program. Int J Med Inform. 2007 Oct;76(10):726-34. doi: 10.1016/j.ijmedinf.2006.07.004. Epub 2006 Sep 20.
PubMed 16996299Finkelstein J, Lapshin O, Cha E. Feasibility of promoting smoking cessation among methadone users using multimedia computer-assisted education. J Med Internet Res. 2008 Nov 3;10(5):e33. doi: 10.2196/jmir.1089.
PubMed 18984556Finkelstein J, Lapshin O, Wasserman E. Randomized study of different anti-stigma media. Patient Educ Couns. 2008 May;71(2):204-14. doi: 10.1016/j.pec.2008.01.002. Epub 2008 Mar 4.
PubMed 18289823Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706.
PubMed 9589228Huang JP, Chen HH, Yeh ML. A comparison of diabetes learning with and without interactive multimedia to improve knowledge, control, and self-care among people with diabetes in Taiwan. Public Health Nurs. 2009 Jul-Aug;26(4):317-28. doi: 10.1111/j.1525-1446.2009.00786.x.
PubMed 19573210Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
PubMed 18453793Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
PubMed 3945130Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Brod M, Christensen T, Kongso JH, Bushnell DM. Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure. J Med Econ. 2009;12(4):309-16. doi: 10.3111/13696990903337017.
PubMed 19811109Zeger SL, Liang KY, Albert PS. Models for longitudinal data: a generalized estimating equation approach. Biometrics. 1988 Dec;44(4):1049-60.
PubMed 3233245
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination
- ClinicalTrials.gov ID
- NCT01493258
- Acronym / sponsor ID
- iADAPT / NA_00040442
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Comparative Effectiveness Research, Interactive computer-assisted education, Informatics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left JHU and is not able to be reached for updates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 15 Dec 2011 (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.
In this project the investigators seek to utilize our experience for developing a comprehensive informatics framework for rapid adaptation and dissemination of Comparative Effectiveness Research (CER) products tailored to different categories of health consumers including difficult-to-reach patients. Based on our previous successful experience in computer-assisted education, the investigators will refine the current CO-ED platform to implement and test a novel system for individualized continuous patient education (iCOPE). The iCOPE platform will be specifically designed to support rapid adaptation, customization, and dissemination of the CER products to the difficult-to-reach populations. The iCOPE platform will implement universal means for customized delivery of CER information in the format of interactive self-paced educational modules, quick "question \& answer" guides, and interactive decision aids. In addition, the iCOPE platform will support the innovative concept of continuous patient health education by providing patients with easy access to the interactive CER updates via web, MP3 players and phone-based interactive voice response (IVR) technology. Though iCOPE will be designed to support the whole spectrum of CER products, in this project the investigators will focus on the Comparative Effectiveness Research Summary Guide (CERSG) entitled "Pills for Type 2 Diabetes."
The following primary hypothesis will be tested in the RCT: Use of the iCOPE platform will be associated with improvement in CERSG knowledge in elderly at 6 months after the intervention.
The investigators will also examine the impact of iCOPE on medication adherence self-efficacy, diabetes medication satisfaction, HbA1c, and CERSG acceptance.
Detailed description
Interactive, computer-based education has the potential to greatly increase interest, because the learner actively participates in the learning process (Fox, 2009). In addition, the involvement of auditory, visual, and interactive learning strategies can increase recall of information. Computer-assisted educational programs may incorporate features that promote ease of use, be written in multiple languages, be scripted at a level that addresses the needs of low literacy learners, and be viewed as often as needed by a patient (Fox, 2009).
Several studies reported results of using computer technology in educating elderly patients about health conditions. Stromberg et al (2006) used a single-session, interactive computer-based educational program about chronic heart failure in elderly patients. They demonstrated that interactive computer-mediated education may be effectively used to increase patients' knowledge, about heart failure. Another study, conducted by Lin et al (2009), evaluated the usability of a touch-screen-enabled personal education program (PEP). The results showed that the system was evaluated as usable and useful, and older adults were satisfied with their experience. Similar findings were reported by Neafsey et al (2008) who also evaluated a patient-centered computer-mediated program using touch screen computers. Authors reported high satisfaction of the older adult users, increased knowledge and self-efficacy for avoiding adverse self-medication behaviors.
Elderly patients are less likely than younger patients to seek incidental information on their condition via internet. (Tian \& Robinson, 2008) Elderly patients therefore are less likely to navigate internet looking for information about evidence or treatment guidelines for their conditions. More targeted efforts may be needed to reach such populations. Disseminating information via combination of high technology media along with traditional media that are easily usable is helpful (Longo, 2005). A recent review of barriers and drivers of health IT use by elderly, very ill, and underserved, revealed that such technology can play a role in offering effective interventions. The consumer perceptions on benefits from use of system, convenience of use, and familiar technology were all important factors for intervention success (Jimison et al., 2008).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The study participants randomized to the Group 2 will serve as a control. At the beginning of the study, they will receive a CERSG brochure printed from the AHRQ site. They will be asked to study it to the best of their ability throughout the day. |
| iCOPE Intervention group | Experimental | Other: iCOPE Intervention groupiCOPE intervention group will receive a CERSG brochure via the iCOPE system. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- have clinical diagnosis of Type 2 diabetes;
- take oral diabetes medications;
- be 65 years of age or older at the time of randomization;
- plan to remain in the Maryland/DC area until the completion of the study follow-up;
- understand English at the 5th grade level.
Key exclusion criteria (3 listed)
- plan to leave Maryland/DC area before the completion of the study follow- up;
- presence of significant cognitive impairment based on a Mini-Mental State Examination (MMSE) score ≤23
- do not speak English.
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 |
|---|---|---|
| iCOPE Intervention groupThe study participants in the intervention group will use iCOPE platform providing adapted CERSG content in an interactive and tailored way. The intervention provided by the iCOPE platform will be implemented with the understanding that it should be user-friendly and not time consuming. Initially, all participants will be asked to complete the computer-mediated interactive CERSG module via touch screen tablet PC provided at hospital, in a primary care office, and in senior centers. The total time to complete the curriculum is about 30 min, however the patients will be able to distribute this time throughout a day at their convenience. Once the educational curriculum is completed, the intervention subjects will receive access to other components of the iCOPE platform. | Other | iCOPE Intervention group |
Primary outcome
Change in CERSG Knowledge Score from baseline to 24-hr and to 6-month follow up
Time frame: The Knowledge Test will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
CERSG Knowledge Score will be used to assess the overall patient knowledge of the information provided in the CERSG entitled "Pills for Type 2 Diabetes." The score will represent a percentage of correct answers to 30 true/false items designed in accordance with the content of the CERSG.
4 secondary outcomes
Medication adherence self-efficacy
Time frame: The medication adherence self-efficacy measure will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
Diabetes Medication Satisfaction
Time frame: Diabetes medication satisfaction measure will be administered at the baseline and at the 6-month follow-up.
Glucosylated hemoglobin (HbA1c)
Time frame: Glucosylated hemoglobin (HbA1c) values will be obtained closest to the date of the baseline evaluation and 6-month follow-up.
CERSG Acceptance
Time frame: The CERSG acceptance measure will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Background: PubMed 18372141Tian Y, Robinson JD. Incidental health information use and media complementarity: a comparison of senior and non-senior cancer patients. Patient Educ Couns. 2008 Jun;71(3):340-4. doi: 10.1016/j.pec.2008.02.006. Epub 2008 Mar 26.
- Background: PubMed 19047879Neafsey PJ, Anderson E, Peabody S, Lin CA, Strickler Z, Vaughn K. Beta testing of a network-based health literacy program tailored for older adults with hypertension. Comput Inform Nurs. 2008 Nov-Dec;26(6):311-9. doi: 10.1097/01.NCN.0000336466.17811.e7.
- Background: PubMed 16098149Longo DR. Understanding health information, communication, and information seeking of patients and consumers: a comprehensive and integrated model. Health Expect. 2005 Sep;8(3):189-94. doi: 10.1111/j.1369-7625.2005.00339.x. No abstract available.
- Background: PubMed 19408968Jimison H, Gorman P, Woods S, Nygren P, Walker M, Norris S, Hersh W. Barriers and drivers of health information technology use for the elderly, chronically ill, and underserved. Evid Rep Technol Assess (Full Rep). 2008 Nov;(175):1-1422.
- Background: PubMed 16779304Lapshin OV, Sharma K, Finkelstein J. Depression education for primary care patients using a web-based program. AMIA Annu Symp Proc. 2005;2005:1017. No abstract available.
- Background: PubMed 16996299Finkelstein J, Lapshin O. Reducing depression stigma using a web-based program. Int J Med Inform. 2007 Oct;76(10):726-34. doi: 10.1016/j.ijmedinf.2006.07.004. Epub 2006 Sep 20.
- Background: PubMed 18984556Finkelstein J, Lapshin O, Cha E. Feasibility of promoting smoking cessation among methadone users using multimedia computer-assisted education. J Med Internet Res. 2008 Nov 3;10(5):e33. doi: 10.2196/jmir.1089.
- Background: PubMed 18289823Finkelstein J, Lapshin O, Wasserman E. Randomized study of different anti-stigma media. Patient Educ Couns. 2008 May;71(2):204-14. doi: 10.1016/j.pec.2008.01.002. Epub 2008 Mar 4.
- Background: PubMed 9589228Fitzgerald JT, Funnell MM, Hess GE, Barr PA, Anderson RM, Hiss RG, Davis WK. The reliability and validity of a brief diabetes knowledge test. Diabetes Care. 1998 May;21(5):706-10. doi: 10.2337/diacare.21.5.706.
- Background: PubMed 19573210Huang JP, Chen HH, Yeh ML. A comparison of diabetes learning with and without interactive multimedia to improve knowledge, control, and self-care among people with diabetes in Taiwan. Public Health Nurs. 2009 Jul-Aug;26(4):317-28. doi: 10.1111/j.1525-1446.2009.00786.x.
- Background: PubMed 18453793Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.
- Background: PubMed 3945130Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Individual participant dataSharing planned: No. The data contain sensitive information
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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.
Joseph Finkelstein, MD, PhD principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCOPE Intervention group in people with Type 2 Diabetes, run by Johns Hopkins University at 3 sites in United States.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CERSG Knowledge Score from baseline to 24-hr and to 6-month follow up (time frame: The Knowledge Test will be administered at the baseline, 24-hr after the introduction of the CERSG, and at the 6-month follow-up.). 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 NCT01493258, which also lists 15 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 18 May 2020.