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Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management

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ClinicalTrials.gov Identifier: NCT02344082
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 8, 2015
First Posted Date  ICMJE January 22, 2015
Last Update Posted Date December 20, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2015)
Change in hemoglobin A1c [ Time Frame: 3 months ]
A1c at 3 months - A1c at Baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02344082 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2015)
  • Patient adherence to office visits (# visits attended/# of visits scheduled) [ Time Frame: 3 months ]
    # visits attended/# of visits scheduled
  • Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made) [ Time Frame: 3 months ]
    Number of pharmacist interventions (lifestyle or medication changes) made
  • Patient satisfaction (Based on survey results) [ Time Frame: 3 months ]
    Based on survey results at final pharmacy clinic visit
  • Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care) [ Time Frame: 3 months ]
    Percent of patients who receive telephone call under usual care
  • Telemedicine Adherence (Percent of telephone encounters completed in intervention arm) [ Time Frame: 3 months ]
    Percent of telephone encounters completed in intervention arm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management
Official Title  ICMJE Not Provided
Brief Summary

This prospective study will include both an intervention and control arm. The control arm will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore Medical Center (EBMC).

Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the intervention group in which patients participate in telemedicine, to a control group in which they do not

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Telemedicine
Intervention  ICMJE Other: Telemedicine
The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.
Study Arms  ICMJE
  • No Intervention: Standard of Care
    The control arm will receive face-to-face pharmacy clinic visits per usual care.
  • Active Comparator: Intervention Arm
    The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.
    Intervention: Other: Telemedicine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2015)
40
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients with a primary care provider at JHOC or EMBC
  • Patients have seen primary care provider within last 6 months
  • Patients with hemoglobin A1c greater than 9%

Exclusion Criteria:

  • Patients <18 years of age
  • Patients with previously established care with JHH ambulatory care pharmacist
  • Patients with communication barriers who do not have a caregiver
  • Patients with new diagnosis of diabetes
  • Patients who are pregnant or planning to become pregnant during the time of the study
  • Patients followed by Endocrinology or Diabetes Center
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344082
Other Study ID Numbers  ICMJE IRB00051947
1819 ( Other Identifier: Other )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP