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Remedies4D: REMEDIES4D: REdesigning MEDication Intensification Effectiveness Study for Diabetes

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01611168
Collaborator
American Diabetes Association (Other)
240
Enrollment
1
Location
2
Arms
44
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Treatment Algorithms
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Redesigning Medication Intensification Effectiveness Study for Diabetes
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Glycated hemoglobin (A1C) [1 year]

    Change in HbA1c blood test

  2. Blood pressure (systolic and diastolic blood pressure [1 year]

    Change in systolic and diastolic blood pressure reading

  3. Lipids (LDLc, HDLc, cholesterol, and triglyceride) [1 year]

    Change in LDLc, HDLc, cholesterol, and triglyceride values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anthony Fabio, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01611168
Other Study ID Numbers:
  • PRO08040023
First Posted:
Jun 4, 2012
Last Update Posted:
May 19, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of May 19, 2017