- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01388465
Text-message Support to Improve Oral Antibiotic Adherence After ED Discharge (ImpACT)
May 18, 2012 updated by: University of Pittsburgh
Feasibility of Using Text-Message Support to Improve Antibiotic Adherence After ED Discharge
The investigators are testing the hypothesis that patients who are exposed to daily text-message (TM) assessments with feedback will have better adherence to prescription than those patients not exposed to TM-based queries with feedback.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Short course, oral antibiotics are frequently prescribed to patients treated/discharged from the Emergency Department.
Medication adherence involves the patient taking the proper daily dosing of prescribed medication for the entire length of time it is prescribed.
Previous studies have shown that prescription non-filling rates range from 5 to 20%.
Other studies have shown that even if patients fill their prescription, as low as 30-40% will properly take the medication.
The purpose of this study is to determine if the proportion of patients discharged from the Emergency Department that are adherent with antibiotics is higher in patients that are provided TM support using self-report.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States
- UPMC Mercy Emergency Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18 and older
- Planned discharge form the ED on oral antibiotics
Exclusion Criteria:
- non-English speaking
- Prisoner
- No personal mobile phone with text message features
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile phone text message Intervention
Daily assessments with feedback about (1) filling prescription and (2) number of doses taken
|
Daily assessment followed by feedback
|
|
No Intervention: Control
No TM queries or feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Successfully picked up prescription within 24 hours of ED discharge
Time Frame: 24 hours post ED discharge
|
We will compare the proporiton of participants in each group who have picked up their prescription within 24 hours of discharge
|
24 hours post ED discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete adherence to oral antibiotics
Time Frame: 3-14 days
|
We will compare the proporiton of participants in either group who have achieved complete adherence to dosing and days of treatment
|
3-14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
July 1, 2011
First Submitted That Met QC Criteria
July 5, 2011
First Posted (Estimate)
July 6, 2011
Study Record Updates
Last Update Posted (Estimate)
May 21, 2012
Last Update Submitted That Met QC Criteria
May 18, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PRO11020492
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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