Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-28 @ 1:12 PM
Study NCT ID:
NCT01611168
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REMEDIES4D: REdesigning MEDication Intensification Effectiveness Study for Diabetes
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Redesigning Medication Intensification Effectiveness Study for Diabetes
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Remedies4D
Brief Summary:
The proposed research study aims to determine whether applying the University of Pittsburgh Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved clinical outcome and process measures as recommended by American Diabetes Association (ADA), quality of life, treatment satisfaction and medication adherence for adults with diabetes, and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care settings will also be assessed.
Detailed Description:
This proposed study is a multi-practice, cluster-design, prospective randomized controlled trial with a total study intervention period of 12 months. This prospective randomized controlled trial will assess the effectiveness of performing NDMPs by the registered nurse supervised by a physician (the intervention group) in comparison with usual diabetes care (the usual care group) for adults with diabetes in primary care settings. The study population will be recruited from University of Pittsburgh Medical Center Community Medicine Inc. (CMI) primary care practices in urban and suburban communities surrounding Pittsburgh, PA. Among these CMI practices, ten practices receive diabetes education services from University of Pittsburgh Diabetes Institute and will be the intervention group. These diabetes education services will be enhanced by the addition of NDMPs intervention. In addition, we will select another 10 CMI practices to be the usual care group. This group receives standard diabetes education with no use of NDMPs. One-hundred and fifty participants will be recruited across practices within each study group (i.e., 300 in total). Outcomes assessed in this study include clinical outcome and process measures as recommended by ADA, participants' quality of life, treatment satisfaction, and medication adherence, and providers' satisfaction, and costs/expenditure. Assessments will be done at baseline, and three and 12 months after the study entry. Analysis of the study outcomes will be based on intention-to-treat to determine (1) within-group differences between the baseline and follow-up visits, and (2) between-group differences between the intervention group and the usual care group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: