Medication AdherenceImpACTNCT01388465
Text-message Support to Improve Oral Antibiotic Adherence After ED Discharge
A study testing Mobile phone text messaging in people with Medication Adherence, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Mobile phone text messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2011
- 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
- Ages 18 and older
- Planned discharge form the ED on oral antibiotics
Who cannot join
- non-English speaking
- Prisoner
- No personal mobile phone with text message features
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Mercy Emergency Department
Pittsburgh, Pennsylvania
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Mobile phone text messaging
- Keywords
- Adherence, Intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone text messagingBehavioural
Daily assessment followed by feedback
| Study group | Role | What they receive |
|---|---|---|
| Mobile phone text message Intervention | Experimental | Daily assessments with feedback about (1) filling prescription and (2) number of doses taken Receives: Behavioral: Mobile phone text messaging |
| Control | No intervention | No TM queries or feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully picked up prescription within 24 hours of ED discharge
We will compare the proporiton of participants in each group who have picked up their prescription within 24 hours of discharge
Measured: 24 hours post ED discharge
Secondary outcomes (1)
Complete adherence to oral antibiotics
We will compare the proporiton of participants in either group who have achieved complete adherence to dosing and days of treatment
Measured: 3-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388465
- Sponsor's protocol ID
- PRO11020492
- Acronym
- ImpACT
- Status last verified
- May 2012
- First submitted
- 1 Jul 2011
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Using Text-Message Support to Improve Antibiotic Adherence After ED Discharge
- ClinicalTrials.gov ID
- NCT01388465
- Acronym / sponsor ID
- ImpACT / PRO11020492
- Conditions
- Medication Adherence
- Keywords
- Adherence, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Jul 2011 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile phone text message Intervention | Experimental | Behavioral: Mobile phone text messagingDaily assessments with feedback about (1) filling prescription and (2) number of doses taken |
| Control | No intervention | –No TM queries or feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 and older
- Planned discharge form the ED on oral antibiotics
Key exclusion criteria (3 listed)
- non-English speaking
- Prisoner
- No personal mobile phone with text message features
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 |
|---|---|---|
| Mobile phone text messagingDaily assessment followed by feedback | Behavioural | Mobile phone text message Intervention |
Primary outcome
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
1 secondary outcome
Complete adherence to oral antibiotics
Time frame: 3-14 days
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 21 May 2012.
Related trials for Medication Adherence
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Recruiting
Improving Adherence to Chronic Disease Medication Regimens Among Patients With Recently Diagnosed Cancer
Cancer
Not yet recruitingObservational study
Daily Cognitive Failures and Medication Adherence in Fibromyalgia
Fibromyalgia
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone text messaging in people with Medication Adherence, run by University of Pittsburgh at 1 site in United States.
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 2 inclusion and 3 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Successfully picked up prescription within 24 hours of ED discharge (time frame: 24 hours post ED discharge). 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 21 May 2012.