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Reducing Emergency Diabetes Care for Older African Americans (COPDE)

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ClinicalTrials.gov Identifier: NCT03466866
Recruitment Status : Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Barry Rovner, Thomas Jefferson University

Brief Summary:

This RCT will compare the efficacy of COPDE (COmmunity Care to Prevent Diabetes Emergencies) vs. intensive home-based diabetes (DM) education [i.e., Enhanced Usual Care (EUC)] to reduce DM-related emergency department (ED) visits and/or hospitalizations over 12 months (primary outcome) in 230 blacks with diabetes, 50 years and older, after an ED visit. A moderation analysis will determine whether participants who reside in low- vs. high-need communities [defined by Community Need Index scores (i.e., an indicator of the built environment)] respond differently to treatment.

COPDE is a collaborative intervention of Primary Care Physicians, (PCPs), a DM nurse educator, and Community Health Workers (CHWs) that extends from the ED into the community. The CHWs will: 1) deliver in-home DM education to increase participants' knowledge and skills to manage DM; 2) use DM-specific Behavioral Activation to reinforce DM self-care; and 3) facilitate telehealth visits with PCPs and a DM nurse educator to increase access to care. The control treatment, EUC, is home-based intensive DM education. EUC matches COPDE in treatment intensity (i.e., number and duration of in-home visits) and delivery of DM self-care education, but does not include COPDE's other active elements (i.e., Behavioral Activation and telehealth). The treatment comparison will identify COPDE's specific efficacy over and above EUC. We hypothesize that COPDE will halve the rate of incident DM-related ED visits and/or hospitalizations relative to EUC. The three secondary outcomes are: 1) subjective perceptions of access to care; 2) receipt of DM Quality Metrics (i.e., objective indicators of realized access to care); and 3) DM self-care.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: COPDE Behavioral: Intensive Diabetes Education Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single blind, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Clinical Trial to Compare the Efficacy of Community Care to Prevent Diabetes Emergencies (COPDE) vs. Intensive Home-based Diabetes Education to Reduce Emergency Visits and Hospitalizations Over 12 Months in African Americans Who Have Diabetes
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPDE
Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.
Behavioral: COPDE
Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.

Active Comparator: Intensive Diabetes Education
In-home diabetes education
Behavioral: Intensive Diabetes Education
In-home diabetes education




Primary Outcome Measures :
  1. number of incident diabetes-related ED visits and/or hospitalizations [ Time Frame: 12 months ]
    The primary efficacy analysis will consider the number of incident diabetes-related ED visits and/or hospitalizations (i.e., an "event") over 12 months after the index ED visit. Each ED visit or hospitalization is counted as a single event (although an ED visit that leads to a hospitalization is counted once). ED visits and hospitalization will be ascertained through chart reviews and subject self-report.


Secondary Outcome Measures :
  1. Perceived access to health care [ Time Frame: 12 months ]
    Change in Patient Satisfaction Questionnaire-18 scores from baseline

  2. Actual access to care [ Time Frame: 12 months ]
    Increase in the number of received Diabetes Quality Metrics (e.g., hemoglobin A1c testing, urine screening) from baseline

  3. Diabetes self-care behaviors [ Time Frame: 12 months ]
    Frequency of engagement in diabetes self-care behaviors (e.g., exercise, diet) as measured by the Diabetes Self-Care Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. African American race (self-identified)
  2. Age ≥ 50 years
  3. Type 1 or 2 DM
  4. A DM-related cause for the ED visit in the opinion of the ED physician
  5. Has a Jefferson PCP (participants receiving COPDE will have a telehealth visit with their Jefferson PCP).

Exclusion Criteria:

  1. Medical or psychiatric morbidity (e.g., acute stroke, schizophrenia) that would preclude study participation in the opinion of the ED physician
  2. Clinically significant cognitive impairment

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): NCT03466866


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Barry w Rovner Thomas Jefferson University
  Study Documents (Full-Text)

Documents provided by Barry Rovner, Thomas Jefferson University:

Responsible Party: Barry Rovner, PI, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03466866     History of Changes
Other Study ID Numbers: R01DK114033-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Emergencies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes