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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01611168
First received: May 15, 2012
Last updated: May 30, 2012
Last verified: May 2012
  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 Phase
Type 2 Diabetes
Other: Treatment Algorithms
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Pittsburgh:

Primary Outcome Measures:
  • Glycated hemoglobin (A1C) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in HbA1c blood test

  • Blood pressure (systolic and diastolic blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in systolic and diastolic blood pressure reading

  • Lipids (LDLc, HDLc, cholesterol, and triglyceride) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change in LDLc, HDLc, cholesterol, and triglyceride valuses


Estimated Enrollment: 370
Study Start Date: April 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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 Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01611168     History of Changes
Other Study ID Numbers: PRO08040023
Study First Received: May 15, 2012
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014