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REMEDIES4D: REdesigning MEDication Intensification Effectiveness Study for Diabetes (Remedies4D)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01611168
First Posted: June 4, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Anthony Fabio, University of Pittsburgh
  Purpose
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.

Condition Intervention
Type 2 Diabetes Other: Treatment Algorithms

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Redesigning Medication Intensification Effectiveness Study for Diabetes

Resource links provided by NLM:


Further study details as provided by Anthony Fabio, University of Pittsburgh:

Primary Outcome Measures:
  • Glycated hemoglobin (A1C) [ Time Frame: 1 year ]
    Change in HbA1c blood test

  • Blood pressure (systolic and diastolic blood pressure [ Time Frame: 1 year ]
    Change in systolic and diastolic blood pressure reading

  • Lipids (LDLc, HDLc, cholesterol, and triglyceride) [ Time Frame: 1 year ]
    Change in LDLc, HDLc, cholesterol, and triglyceride values


Enrollment: 240
Actual Study Start Date: April 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Experimental: Intervention Group, treatment algorithms Other: Treatment Algorithms
subjects in the intervention group will receive diabetes care from a well-trained registered nurse (RN) who will follow approved treatment algorithms/protocols for glycemia, high blood pressure, lipids and microalbuminuria.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18 or greater
  2. The diagnosis of type 2 diabetes of the subjects should be 1 year or more prior to the inception of this study
  3. Subjects will be on medication treatment for their type 2 diabetes
  4. Subjects' A1C levels should be higher than 7% for study entry
  5. LDLc>100mg/d*l or
  6. Blood Pressure >130/80*mg/dl
  7. Any combination of the #4, 5 &6 At least one visit to the practice within the previous 12 months.

Exclusion Criteria:

  1. Non-ambulatory
  2. Gestational diabetes
  3. Pregnant women (by self-report)
  4. Subjects have received diabetes education services performed by the registered nurse from UPDI
  5. Subjects are treated with exercise and diet only
  6. Subjects are participating or will participate in other research studies
  7. Subjects do not have insurance or cannot afford payments for diabetes care/treatment
  8. Subjects are unable to read and comprehend English
  9. Subjects are unable to provide informed consent
  10. Other medical conditions for which these protocols are deemed inappropriate by the physician.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611168


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Community Medicine Inc. (UPMC CMI) Primary Care Practices
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
American Diabetes Association
Investigators
Principal Investigator: Janice Zgibor, RPh PhD University of South Florida
  More Information

Responsible Party: Anthony Fabio, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01611168     History of Changes
Other Study ID Numbers: PRO08040023
First Submitted: May 15, 2012
First Posted: June 4, 2012
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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