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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01493258 |
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Date of registration:
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09/12/2011 |
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Primary sponsor: |
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Public title:
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Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination
iADAPT |
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Scientific title:
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Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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360 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01493258 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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McKenzie Bedra, MPH |
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Address:
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Telephone:
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410-955-1173 |
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Email:
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mbedra1@jhmi.edu |
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Affiliation:
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Name:
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Joseph Finkelstein, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Other: iCOPE Intervention group
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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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.]
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Diabetes Medication Satisfaction
[Time Frame: Diabetes medication satisfaction measure will be administered at the baseline and at the 6-month follow-up.]
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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.]
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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.]
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Secondary ID(s)
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NA_00040442
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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