Comparative Effectiveness of Two Approaches to Diabetes Management in the Uninsured
2 other identifiers
interventional
64
0 countries
N/A
Brief Summary
The results of the pre-pilot and pilot studies will be used to determine the feasibility of a fully powered trial that will test the effectiveness of two different approaches to diabetes management in an uninsured diabetic population who receives their care from a community based free clinic, namely nurse-directed interdisciplinary care management compared to peer-led self management. Effective programs for the uninsured diabetic will benefit both the individual and society by preventing serious illness, decreasing mortality and disability, decreasing medical debt, stimulating economic growth, improving business productivity, reducing job lock, decreasing health disparities, improving quality of life, and reducing cost shifting by decreasing uncompensated care. Findings will be generalizable to uninsured and insured patients across a wide spectrum of chronic conditions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Aug 2011
Longer than P75 for not_applicable diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
July 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJuly 20, 2015
July 1, 2015
3.7 years
July 20, 2012
July 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
hemoglobin A1c
change from baseline at 6 months for pre-pilot and change from baseline at 6 months and change from baseline at 12 months for pilot
Study Arms (2)
Nurse-led care management
EXPERIMENTALNurse-led care management involves a nurse care manager who performs a comprehensive assessment of the patient then presents those assessment findings to an interdisciplinary team. The team makes care recommendations that are implemented by the care manager in collaboration with the patient's PCP.
peer-led self managment
EXPERIMENTALPeer-led self management follows the chronic disease self management model where peer counselors lead self management classes for 6 weeks, then conduct monthly support groups
Interventions
Eligibility Criteria
You may qualify if:
- patients will be eligible if they are between the ages of 25 and 75,
You may not qualify if:
- have no other illness that would dominate their care (e.g., terminal cancer, numerous exacerbations of CHF), and
- are not pregnant.
- patients must have no cognitive impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Summa Health Systemlead
- Ohio State Universitycollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward D Scott, MD
Summa Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
July 20, 2012
First Posted
July 31, 2012
Study Start
August 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 20, 2015
Record last verified: 2015-07