Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination

NCT01493258 | Withdrawn

• 1 other identifier: NA_00040442
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Comparative Effectiveness Research; Interactive computer-assisted education; Informatics

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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 will be administered at the baseline and at the 6-month follow-up.

• Glucosylated hemoglobin (HbA1c)

  Glucosylated hemoglobin (HbA1c) values will be obtained closest to the date of the baseline evaluation and 6-month follow-up.

• CERSG Acceptance

  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.

Study Arms (2)

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.

Other: iCOPE Intervention group

Interventions

iCOPE Intervention group OTHER

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.

iCOPE Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (15)

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  PMID: 18372141 BACKGROUND

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  PMID: 16098149 BACKGROUND

• Jimison 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.

  PMID: 19408968 BACKGROUND

• Lapshin 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.

  PMID: 16779304 BACKGROUND

• Finkelstein 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.

  PMID: 16996299 BACKGROUND

• Finkelstein 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.

  PMID: 18984556 BACKGROUND

• Finkelstein 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.

  PMID: 18289823 BACKGROUND

• Fitzgerald 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.

  PMID: 9589228 BACKGROUND

• Huang 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.

  PMID: 19573210 BACKGROUND

• Morisky 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.

  PMID: 18453793 BACKGROUND

• Morisky 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.

  PMID: 3945130 BACKGROUND

• Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.

  PMID: 16079372 BACKGROUND

• Brod 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.

  PMID: 19811109 BACKGROUND

• Zeger SL, Liang KY, Albert PS. Models for longitudinal data: a generalized estimating equation approach. Biometrics. 1988 Dec;44(4):1049-60.

  PMID: 3233245 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Joseph Finkelstein, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 15, 2011
• Study Start: August 1, 2010
• Last Updated: May 18, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)