Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination (iADAPT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Joseph Finkelstein, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01493258
First received: December 9, 2011
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: iCOPE Intervention group

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comprehensive Informatics Framework for Comparative Effectiveness Research (CER) Dissemination

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Medication adherence self-efficacy will measure self-efficacy of taking medications.

  • Diabetes Medication Satisfaction [ Time Frame: Diabetes medication satisfaction measure will be administered at the baseline and at the 6-month follow-up. ] [ Designated as safety issue: No ]
    Diabetes Medication Satisfaction measure is a diabetes-specific measure, assessing medication treatment satisfaction in three domains: Efficacy, Burden, Symptoms (Side Effects).

  • 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. ] [ Designated as safety issue: No ]
    Glucosylated hemoglobin (HbA1c) will be obtained from Electronic Medical Record (Centricity) at Johns Hopkins Community Physicians (JHCP).

  • 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. ] [ Designated as safety issue: No ]
    CERSG acceptance will measure patient acceptance and comprehension of CERSG


Estimated Enrollment: 360
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
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.
Other: iCOPE Intervention group
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.

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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493258

Contacts
Contact: McKenzie Bedra, MPH 410-955-1173 mbedra1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: McKenzie Bedra, MPH    410-955-1193    mbedra1@jhmi.edu   
Sub-Investigator: Amy Knight, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: McKenzie Bedra, MPH    410-955-1193    mbedra1@jhmi.edu   
Principal Investigator: Joseph Finkelstein, MD, PhD         
Sub-Investigator: Hanan Aboumatar, MD         
Sub-Investigator: Lee Bone, MPH         
Sub-Investigator: Daniel Brotman, MD         
Sub-Investigator: Spyridon Marinopoulos, MBA, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: McKenzie Bedra, MPH    410-955-1173    mbedra1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Joseph Finkelstein, MD, PhD Johns Hopkins University
  More Information

Publications:

Responsible Party: Dr. Joseph Finkelstein, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01493258     History of Changes
Other Study ID Numbers: NA_00040442
Study First Received: December 9, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Diabetes
Comparative Effectiveness Research
Interactive computer-assisted education
Informatics

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014