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Completed

NCT Number: NCT04709939

Mobile-health Approach to Gather Clinical Information From Patients Following Hospital Discharge

The purpose of this study is to assess the feasibility of using a mobile-health approach to gather clinical data from patients following discharge from the hospital on outpatient parenteral antibiotic therapy (OPAT). The study population will consist of adult participants who have a smartphone that is capable of both text messaging and pairing with a Bluetooth thermometer that will be provided. Following discharge, patients will be asked to respond to two daily text messages. They will also be reminded to take and send in photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data. Information from the patient's medical record will be collected at the time of hospital discharge as well as at the end of the study period.

Additionally, a focus group (via conference call) will be conducted with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

About this study

Following hospital discharge on OPAT, patients will be asked to respond to two daily text messages, one in the morning and one in the evening. The message will 1) ask them to take their temperature using the provided thermometer, 2) will provide a link to a web-based survey that will ask about any symptoms as well as provide a free text response field, and 3) remind them to take and send in any photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data.

Additional information will also be collected from the patient and their medical record at the time of hospital discharge (patient caregiver situation, pronouns to address them, artificial material in joints or bones, biological sex, race, ethnicity, height, weight, BMI, zip code, insurance, reason for OPAT, organisms in cultures, where patient is receiving discharge medication, discharge medications, and any other diagnoses/co-morbidities) as well as 2 months after enrollment (any readmission dates and reasons, emergency room visit dates and reasons, clinic visit dates and reasons, and medication changes within 30 days of starting OPAT). These data will be collected 2 months after enrollment to ensure that all readmissions, visits, and medication changes are captured in the medical record.

The software will save time-stamped responses to all web-based surveys, photos sent in, and temperatures taken by the thermometer.

Additionally, a focus group will be conducted (via conference call) with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools. This conference call will be video and audio recorded.

There will not be any long-term follow up for the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • Age 18 to 100
  • Being discharged from hospital on OPAT
  • Owns a smartphone capable of text messaging and being paired to Bluetooth thermometer
  • Able to send SMS and MMS messages via phone

Patient Exclusion Criteria:

  • Prisoner status
  • Unable to provide own written, informed consent

Physician Inclusion Criteria:

  • Infectious disease physician who prescribes OPAT

Physician Exclusion Criteria:

  • None

Treatment and study plan

OPAT

Other

Observation of patients who are discharged from the hospital on OPAT.

Focus Group

Other

Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.

Primary outcomes

  1. Number of Days with a Temperature Reading

    Time frame: 30 days

    The number of days that participants submit a temperature reading during the course of the study.

  2. Number of Completed Surveys

    Time frame: 30 days

    The number of completed surveys that the participant submits over the course of the study.

  3. Number of Photos Sent

    Time frame: 30 days

    The number of photos that the participant submits over the course of the study.

  4. Sample Size Estimation for Future Study

    Time frame: 30 days

    The sample size required to conduct a powered study in the future.

Secondary outcomes

  1. Suggestions for Future Use survey

    Time frame: 30 days

    Feedback from focus group participants for future applications of the methods.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)

Registry information

Official study title

Determining the Acceptability and Feasibility of Mobile-health Approaches to Gather Clinical Information From Patients at Home Following Hospital Discharge

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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