Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers

April 21, 2021 updated by: Cynthia Foronda, University of Miami
The goal of this project is to implement and evaluate a novel intervention for low-income families to reduce the burden of caregivers of a child with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami

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

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Must be age 18 or older
  2. Able to speak and read English or Spanish
  3. Have a smartphone or computer with active service
  4. Care for a child with asthma between ages 5-12
  5. Agree to participate

Exclusion criteria:

  1. Age less than 18
  2. Inability to speak and read English or Spanish
  3. Does not have a smartphone or computer with active service
  4. Child does not have asthma
  5. Care for a child less than 5 or greater than 12
  6. Decline to participate
  7. Prisoners

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Asthma Academy Training + Telehealth Visit Group
Participants will receive the Asthma Academy Training virtually. One week after the virtual training, participants will be scheduled to complete a Telehealth visit via zoom through their smart phones or computers.
Behavioral: Asthma Academy
The Asthma Academy is a one hour virtual training that includes providing information about asthma, asthma medications, communicating with healthcare providers and navigating healthcare resources.
Behavioral: Telehealth Visit
The telehealth Visit will be conduct by a trained Doctor of Nurse Practice (DNP) student via a scheduled meeting through zoom on the participant's smart phone or computer. The visit will last about one hour wherein participant will be asked about their asthma knowledge and will be given information about asthma.
Experimental: Virtual Asthma Academy Training
Participants will receive the virtual Asthma Academy Training via zoom through their smart phones or computers.
Behavioral: Asthma Academy
The Asthma Academy is a one hour virtual training that includes providing information about asthma, asthma medications, communicating with healthcare providers and navigating healthcare resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Caregiver's asthma knowledge
Time Frame: Baseline, Week 3
The preliminary effect of the intervention in caregiver's asthma knowledge will be assessed via the Asthma Knowledge Questionnaire. The questionnaire is completed by the caregiver and has 17 items with a total score range of 17-85 with a higher score indicating higher asthma knowledge.
Baseline, Week 3
Change in Caregiver's sleep
Time Frame: Baseline, Week 3
The preliminary effect of the intervention in caregiver's sleep will be assessed via the Adult Sickle Cell Quality of Life Measurement (ASCQ-Me) Version 2.0 Sleep Impact - Short Form Questionnaire. The questionnaire is completed by the caregiver and has 5 items with each item having a scoring possibility of 1-5. The total score ranges from 5-25 with a higher score indicating better sleep.
Baseline, Week 3
Change in Caregiver's anxiety
Time Frame: Baseline, Week 3
The preliminary effect of the intervention in caregiver's anxiety will be assessed via the Quality of Life in Neurological Disorders (Neuro-QOL ) Anxiety - Short Form Questionnaire. The questionnaire is completed by the caregiver and has 8 items with each item having a scoring possibility of 1-5. The total score ranges from 8-40 with a higher score indicating increased anxiety symptoms.
Baseline, Week 3
Change in Caregiver's depressive symptoms
Time Frame: Baseline, Week 3
The preliminary effect of the intervention in caregiver's depressive symptoms will be assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Short Form 8a Questionnaire. The questionnaire is completed by the caregiver and has 8 items with each item having a scoring possibility of 1-5. The total score ranges from 8-40 with a higher score indicating increased depressive symptoms.
Baseline, Week 3
Performance of DNP students conducting the Teleheath Visits
Time Frame: Week 3
Performance of the DNP students conducting the telehealth visits will be evaluated by the average score rated by a faculty and a peer for each DNP. Each total score is tallied from 5 performance categories with each category having a scoring possibility of 0-3. The total score ranges from 0-15 with the higher score indicating a better performance.
Week 3
Correlation of DNP student performance with family caregiver outcome
Time Frame: Week 3
The correlation of the performance of the DNP student providing the intervention will be evaluated against the caregiver's asthma knowledge, sleep, anxiety and depressive symptom outcomes.
Week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Josiah Macy, Jr. Foundation

Investigators

  • Principal Investigator: Cynthia Foronda, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 24, 2021

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

April 19, 2021

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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