NCT04132297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

October 14, 2019

Last Update Submit

April 21, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Virtual Asthma Academy Training + Telehealth Visit Group

EXPERIMENTAL

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 AcademyBehavioral: Telehealth Visit

Virtual Asthma Academy Training

EXPERIMENTAL

Participants will receive the virtual Asthma Academy Training via zoom through their smart phones or computers.

Behavioral: Asthma Academy

Interventions

Asthma AcademyBEHAVIORAL

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.

Virtual Asthma Academy TrainingVirtual Asthma Academy Training + Telehealth Visit Group

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.

Virtual Asthma Academy Training + Telehealth Visit Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Cynthia Foronda

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 14, 2019

First Posted

October 18, 2019

Study Start

February 24, 2021

Primary Completion

April 19, 2021

Study Completion

April 19, 2021

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations