Asthma in Children
Conditions
Keywords
asthma, spirometry, telehealth
Brief summary
The goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma. The main questions to answer are: 1. Do participants find the program to be feasible, acceptable and accessible? 2. What factors are associated with completion of the program? 3. Does the program have an effect on asthma control and daytime sleepiness?
Detailed description
The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and accessibility. Additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.
Interventions
BEHAVIORALPilot study arm for technology-enhanced asthma intervention
Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
Sponsors
National Institute of General Medical Sciences (NIGMS)
Nemours Children's Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
15 participants will be enrolled in single-group pilot study to measure acceptability, feasibility, and accessibility of mobile spirometry for asthma
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Followed by a Primary Care Practice meeting HRSA rural or medically underserved designation status * Diagnosis of persistent asthma: on at least 1 controller/ preventative medication for asthma * Ability to follow directions and perform study measures, including in-office spirometry at initial visit * Access to mobile device with internet connectivity to connect to telehealth visit and mobile spirometer application
Exclusion criteria
* Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease) * Non-English Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Retention %) | 24 weeks | Feasibility will be evaluated by calculating retention rates at week 24. |
| Acceptability | 24 weeks | To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond agree or strongly agree to each item will be measured. |
| Accessibility | 24 weeks | The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage) | Baseline | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results. |
| Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control. | Baseline and Week 24 | The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control. |
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions) | Baseline | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results. |
| Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits) | Baseline | Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results |
| Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness. | Baseline and Week 24 | The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest). |
| Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | 24 weeks | The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pilot Study Arm for Technology-enhanced Asthma Intervention |
|---|---|
| Age, Categorical <=18 years | 15 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Acceptability
To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond agree or strongly agree to each item will be measured.
Time frame: 24 weeks
Population: Results of Satisfaction and Usability Survey for 12 participants who completed the pilot and also completed this measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It was easy to use | 12 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It was convenient to use | 12 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | The time spent was just about right. | 12 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | The introduction and training was enough. | 12 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | I would recommend the program to others. | 12 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It helped me change my asthma habits. | 11 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It helped me to understand the importance of following my asthma plan. | 10 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It helped me to manage my asthma in a way that I could not have done myself. | 10 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It helped me to understand my asthma better. | 11 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Acceptability | It helped me to understand how to control my asthma. | 10 Participants |
Primary
Accessibility
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Time frame: 24 weeks
Population: Remote visits (5 total) of 14 participants who completed pilot were analyzed for technical concerns.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Accessibility | Visits with Technical Challenges | 9 Remote study visits |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Accessibility | Visits without technical challenges | 61 Remote study visits |
Primary
Feasibility (Retention %)
Feasibility will be evaluated by calculating retention rates at week 24.
Time frame: 24 weeks
Population: Participants who completed the pilot through final study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Feasibility (Retention %) | 14 Participants |
Secondary
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results
Time frame: Baseline
Population: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits) | 1 ER visits |
| Participants Who Did Not Complete Pilot | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits) | 0 ER visits |
Secondary
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results.
Time frame: Baseline
Population: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions) | 0 Admissions |
| Participants Who Did Not Complete Pilot | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions) | 0 Admissions |
Secondary
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results.
Time frame: Baseline
Population: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage) | 1 Courses |
| Participants Who Did Not Complete Pilot | Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage) | 0 Courses |
Secondary
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level.
Time frame: 24 weeks
Population: Characteristics of participants who completed pilot were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Sex: Male | 4 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: White | 7 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Ethnicity: Non-Hispanic | 11 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: Black or African-American | 4 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Sex: Female | 10 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: More than one race | 3 Participants |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Ethnicity: Hispanic | 3 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: More than one race | 0 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Ethnicity: Hispanic | 0 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Ethnicity: Non-Hispanic | 1 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Sex: Male | 1 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Sex: Female | 0 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: White | 0 Participants |
| Participants Who Did Not Complete Pilot | Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention. | Race: Black or African-American | 1 Participants |
Secondary
Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control.
Time frame: Baseline and Week 24
Population: ACT of 14 participants who completed the pilot were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control. | Baseline ACT -Week 0 (median) | 23 score on a scale |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control. | Final ACT- Week 24 (median) | 22 score on a scale |
Secondary
Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest).
Time frame: Baseline and Week 24
Population: ESS-CHAD scores of all participants who completed the pilot.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness. | Baseline Week 0 ESS-CHAD (Median) | 6 score on a scale |
| Pilot Study Arm for Technology-enhanced Asthma Intervention | Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness. | Final- Week 24 ESS-CHAD (median) | 4 score on a scale |