TelemedicineNCT02344082
Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management
A study testing Telemedicine in people with Telemedicine, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
About this study
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
- Conditions
- Telemedicine
- Being tested
- Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin A1c
A1c at 3 months - A1c at Baseline
Measured: 3 months
Secondary outcomes (5)
Patient adherence to office visits (# visits attended/# of visits scheduled)
# visits attended/# of visits scheduled
Measured: 3 months
Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made)
Number of pharmacist interventions (lifestyle or medication changes) made
Measured: 3 months
Patient satisfaction (Based on survey results)
Based on survey results at final pharmacy clinic visit
Measured: 3 months
Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care)
Percent of patients who receive telephone call under usual care
Measured: 3 months
Telemedicine Adherence (Percent of telephone encounters completed in intervention arm)
Percent of telephone encounters completed in intervention arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344082
- Sponsor's protocol ID
- IRB00051947
- Other IDs
- 1819
- Status last verified
- Dec 2018
- First submitted
- 8 Jan 2015
- Last updated
- 20 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management
- ClinicalTrials.gov ID
- NCT02344082
- Acronym / sponsor ID
- IRB00051947
- Conditions
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The control arm will receive face-to-face pharmacy clinic visits per usual care. |
| Intervention Arm | Active comparator | Other: TelemedicineThe intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineThe intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. | Other | Intervention Arm |
Primary outcome
Change in hemoglobin A1c
Time frame: 3 months
A1c at 3 months - A1c at Baseline
5 secondary outcomes
Patient adherence to office visits (# visits attended/# of visits scheduled)
Time frame: 3 months
Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made)
Time frame: 3 months
Patient satisfaction (Based on survey results)
Time frame: 3 months
Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care)
Time frame: 3 months
Telemedicine Adherence (Percent of telephone encounters completed in intervention arm)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
Related trials for Telemedicine
Recruiting
Tele-HOPE: A Telehealth Pharmacist Opioid Patient Education Pilot Study
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Telemedicine, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.