Congestive Heart FailureNCT02568514
Study of the Effect on Clinical Outcomes Using Secure Text Messaging
A study testing Secure text messaging in people with Congestive Heart Failure and Diabetes, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congestive Heart Failure, Diabetes, Renal Failure
- What is being tested?
- Secure text messaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission to one of the hospital floors or services in the study at the Hospital of the University of Pennsylvania
Who cannot join
- Discharges against medical advice
- Discharges to hospice
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.
Read the detailed description
Inpatient health care providers such as physicians and nurses spend up to one-third of their time communicating with other health care providers. Many of these communications have shifted mediums from handwritten notes and face-to-face conversations to phone calls and paging systems. More recently the rapid adoption of smartphones has led to the use of mobile-enabled technologies using smartphones such as text messaging and email. While these technologies may offer ease and fit better within the clinical workflow, they often send patient information through unsecure cellular or internet connections. Mobile secure text messaging may address these issues by encrypting data and allowing for asynchronous or synchronous communication between individual providers or groups of providers. In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.
- Conditions
- Congestive Heart Failure, Diabetes, Renal Failure, Copd
- Being tested
- Secure text messaging
- Keywords
- mhealth, text messaging, secure text messaging, communication
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Renal Insufficiency, Pulmonary Disease, Chronic Obstructive, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secure text messagingDevice
A smartphone and web application that allows physicians and other health care professionals to communicate to each other by secure text message
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Patients admitted to hospital floors without any other intervention. |
| Secure text messaging | Experimental | Patients admitted to hospital floors on which physicians and other staff are able to communicate with each other (not to the patient) using mobile secure text messaging. Receives: Device: Secure text messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in length of stay
Change in inpatient length of stay from baseline to 6 months
Measured: 6 months
Change in 30 day hospital readmissions
Change in 30 day hospital readmissions from baseline to 6 months
Measured: 6 months
Change in inpatient mortality
Change in inpatient mortality from baseline to 6 months
Measured: 6 months
Secondary outcomes (1)
Change in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPs) scores
Change in HCAP scores from baseline to 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568514
- Sponsor's protocol ID
- 823096
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect on Clinical Outcomes Using Secure Text Messaging
- ClinicalTrials.gov ID
- NCT02568514
- Acronym / sponsor ID
- 823096
- Conditions
- Congestive Heart Failure, Diabetes, Renal Failure, Copd
- Keywords
- mhealth, text messaging, secure text messaging, communication
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Oct 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.
In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.
Detailed description
Inpatient health care providers such as physicians and nurses spend up to one-third of their time communicating with other health care providers. Many of these communications have shifted mediums from handwritten notes and face-to-face conversations to phone calls and paging systems. More recently the rapid adoption of smartphones has led to the use of mobile-enabled technologies using smartphones such as text messaging and email. While these technologies may offer ease and fit better within the clinical workflow, they often send patient information through unsecure cellular or internet connections. Mobile secure text messaging may address these issues by encrypting data and allowing for asynchronous or synchronous communication between individual providers or groups of providers. In this study, the investigators will conduct a randomized, controlled trial to evaluate the impact of offering mobile secure text messaging on clinical outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Patients admitted to hospital floors without any other intervention. |
| Secure text messaging | Experimental | Device: Secure text messagingPatients admitted to hospital floors on which physicians and other staff are able to communicate with each other (not to the patient) using mobile secure text messaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to one of the hospital floors or services in the study at the Hospital of the University of Pennsylvania
Key exclusion criteria (2 listed)
- Discharges against medical advice
- Discharges to hospice
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 |
|---|---|---|
| Secure text messagingA smartphone and web application that allows physicians and other health care professionals to communicate to each other by secure text message | Device | Secure text messaging |
Primary outcome
Change in length of stay
Time frame: 6 months
Change in inpatient length of stay from baseline to 6 months
Change in 30 day hospital readmissions
Time frame: 6 months
Change in 30 day hospital readmissions from baseline to 6 months
Change in inpatient mortality
Time frame: 6 months
Change in inpatient mortality from baseline to 6 months
1 secondary outcome
Change in Hospital Consumer Assessment of Healthcare Providers and Systems (HCAPs) scores
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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.
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secure text messaging in people with Congestive Heart Failure and Diabetes, run by University of Pennsylvania 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 Apr 2017. 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 was withdrawn before enrolling participants, so there are no results.
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 length of stay (time frame: 6 months). The study lists 3 primary outcomes in all. 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 10 Apr 2017.