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

May 31, 2023 updated by: University of Pittsburgh

Redesigning Medication Intensification Effectiveness Study for Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Community Medicine Inc. (UPMC CMI) Primary Care Practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (A1C)
Time Frame: 1 year
Change in HbA1c blood test
1 year
Blood pressure (systolic and diastolic blood pressure
Time Frame: 1 year
Change in systolic and diastolic blood pressure reading
1 year
Lipids (LDLc, HDLc, cholesterol, and triglyceride)
Time Frame: 1 year
Change in LDLc, HDLc, cholesterol, and triglyceride values
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Janice Zgibor, RPh PhD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimated)

June 4, 2012

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO08040023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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