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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04132297
Other study ID # 20190884
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2021
Est. completion date April 19, 2021

Study information

Verified date April 2021
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 19, 2021
Est. primary completion date April 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Miami Coral Gables Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Josiah Macy, Jr. Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Week 3
Primary 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. Baseline, Week 3
Primary 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. Baseline, Week 3
Primary 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. Baseline, Week 3
Primary 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. Week 3
Primary 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. Week 3
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