Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Primary Purpose
Caregiver Burnout
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Academy
Telehealth Visit
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burnout
Eligibility Criteria
Inclusion criteria:
- Must be age 18 or older
- Able to speak and read English or Spanish
- Have a smartphone or computer with active service
- Care for a child with asthma between ages 5-12
- Agree to participate
Exclusion criteria:
- Age less than 18
- Inability to speak and read English or Spanish
- Does not have a smartphone or computer with active service
- Child does not have asthma
- Care for a child less than 5 or greater than 12
- Decline to participate
- Prisoners
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Virtual Asthma Academy Training + Telehealth Visit Group
Virtual Asthma Academy Training
Arm Description
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.
Participants will receive the virtual Asthma Academy Training via zoom through their smart phones or computers.
Outcomes
Primary Outcome Measures
Change in Caregiver's asthma knowledge
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.
Change in Caregiver's sleep
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.
Change in Caregiver's anxiety
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.
Change in Caregiver's depressive symptoms
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.
Performance of DNP students conducting the Teleheath Visits
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.
Correlation of DNP student performance with family caregiver outcome
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04132297
First Posted
October 14, 2019
Last Updated
April 21, 2021
Sponsor
University of Miami
Collaborators
Josiah Macy, Jr. Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04132297
Brief Title
Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Official Title
Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
April 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Josiah Macy, Jr. Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Asthma Academy Training + Telehealth Visit Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Asthma Academy Training
Arm Type
Experimental
Arm Description
Participants will receive the virtual Asthma Academy Training via zoom through their smart phones or computers.
Intervention Type
Behavioral
Intervention Name(s)
Asthma Academy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Caregiver's asthma knowledge
Description
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.
Time Frame
Baseline, Week 3
Title
Change in Caregiver's sleep
Description
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.
Time Frame
Baseline, Week 3
Title
Change in Caregiver's anxiety
Description
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.
Time Frame
Baseline, Week 3
Title
Change in Caregiver's depressive symptoms
Description
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.
Time Frame
Baseline, Week 3
Title
Performance of DNP students conducting the Teleheath Visits
Description
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.
Time Frame
Week 3
Title
Correlation of DNP student performance with family caregiver outcome
Description
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.
Time Frame
Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Must be age 18 or older
Able to speak and read English or Spanish
Have a smartphone or computer with active service
Care for a child with asthma between ages 5-12
Agree to participate
Exclusion criteria:
Age less than 18
Inability to speak and read English or Spanish
Does not have a smartphone or computer with active service
Child does not have asthma
Care for a child less than 5 or greater than 12
Decline to participate
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Foronda
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34913268
Citation
Foronda C, Prather S, Snowden K, Gonzalez JM, Gattamorta KA, Lee J, Gonzalez JE, Cardenas M. Asthma academy: A student nurse-led telehealth education program for low-income family caregivers of children with asthma. Nurs Open. 2022 Mar;9(2):1486-1496. doi: 10.1002/nop2.1123. Epub 2021 Dec 16.
Results Reference
derived
Learn more about this trial
Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
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