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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 : Unknown
Verified January 2015 by Gail Berkenblit, Johns Hopkins University.
Recruitment status was:  Enrolling by invitation
First Posted : January 22, 2015
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Gail Berkenblit, Johns Hopkins University

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


Condition or disease Intervention/treatment Phase
Telemedicine Other: Telemedicine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : January 2015
Estimated Primary Completion Date : April 2015

Arm Intervention/treatment
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.
Other: Telemedicine
The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.




Primary Outcome Measures :
  1. Change in hemoglobin A1c [ Time Frame: 3 months ]
    A1c at 3 months - A1c at Baseline


Secondary Outcome Measures :
  1. Patient adherence to office visits (# visits attended/# of visits scheduled) [ Time Frame: 3 months ]
    # visits attended/# of visits scheduled

  2. Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made) [ Time Frame: 3 months ]
    Number of pharmacist interventions (lifestyle or medication changes) made

  3. Patient satisfaction (Based on survey results) [ Time Frame: 3 months ]
    Based on survey results at final pharmacy clinic visit

  4. 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

  5. Telemedicine Adherence (Percent of telephone encounters completed in intervention arm) [ Time Frame: 3 months ]
    Percent of telephone encounters completed in intervention arm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Gail Berkenblit, Assistant Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02344082     History of Changes
Other Study ID Numbers: 1819
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015