NCT02344082

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

January 8, 2015

Last Update Submit

December 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin A1c

    A1c at 3 months - A1c at Baseline

    3 months

Secondary Outcomes (5)

  • Patient adherence to office visits (# visits attended/# of visits scheduled)

    3 months

  • Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made)

    3 months

  • Patient satisfaction (Based on survey results)

    3 months

  • Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care)

    3 months

  • Telemedicine Adherence (Percent of telephone encounters completed in intervention arm)

    3 months

Study Arms (2)

Standard of Care

NO INTERVENTION

The control arm will receive face-to-face pharmacy clinic visits per usual care.

Intervention Arm

ACTIVE COMPARATOR

The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.

Other: Telemedicine

Interventions

The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 22, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 20, 2018

Record last verified: 2018-12