Ignite Creation Date:
2024-05-06 @ 2:35 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04365556
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2020-04-17
Brief Title:
Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Using Technology-Assisted Stepped Care Intervention to Improve Adherence in Adolescents With Asthma
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASC
Brief Summary:
To test the preliminary efficacy of the TASC adherence promotion intervention for adolescents with asthma in a feasibility randomized controlled trial compared to treatment as usual control arm
Detailed Description:
The current study involving human subjects consists of a Randomized Controlled Trial to test the feasibility effectiveness and implementation of the TASC intervention as compared to a treatment as usual group A total of up to 70 adolescents with moderate or severe persistent asthma between the ages of 12-18 years will be randomized to TASC n35 or treatment as usual n 35 After adolescent participants have met inclusion criteria completed baseline assessments and have been enrolled in the feasibility RCT they will be randomized to either TASC or Treatment As Usual TAU Outcomes measures adherence and disease severity will be assessed at baseline monthly during active treatment and at post-treatment with the primary endpoint being post-treatment Participants will be enrolled in the study for a duration of six months The TASC intervention will be delivered using technology so that participants do not need any resources to travel to appointments Step 1 Information will include electronic educational information related to asthma symptoms and triggers attacks self-monitoring treatments action plans and automated text message medication reminders Step 1 will be provided to all adolescents Adherence will be electronically monitored but feedback will not be provided Step 2 Motivation will include electronic monitoring of adherence and personally tailored feedback via text messages Adolescents will be given access to the adherence tracking smartphone app and graphs of their inhaler adherence Adolescents will also receive brief personalized text messages that provide supportive motivation and directive tangible actions Step 3 Behavioral will include problem-solving telehealth intervention with a trained clinician Four telehealth sessions individually tailored to the unique needs and barriers of the adolescent will be provided These will be based on a functional analysis via objective adherence data graphical feedback and discussion of adherence patterns allowing for a comprehensive understanding of specific behavioral factors interfering with adherence Behavioral treatment plans will be modified based on a patients progress in treatmentand ability to achieve short-term adherence goals Patients will also be contacted via text messaging to assess success with specific adherence plans between sessions based on objective data This telehealth intervention will be delivered to adolescents cell phones via video conferencing software
All participants will complete baseline questionnaires related to demographic and clinical predictors of adherence and asthma They will be randomized following completion of baseline measures Inhaler adherence caps will also be provided to all participants and utilized for 2 months without feedback to obtain baseline adherence In addition all participants receive a mobile spirometer to track their lung function throughout the study The spirometer connects to an app via Bluetooth This app allows the participant to perform pulmonary function tests PFTs and view the results of these tests such as their forced expiratory volume FEV1 as well as other lung function parameters All participants will be asked to use the spirometer at least once a month when completing study visits over the phone with a study team member Following the baseline visit an 8 week run-in phase will be completed to assess baseline adherence using electronic inhaler monitoring After obtaining 4 weeks of adherence data the coordinator will call the participants in TASC and TAU for their first monthly phone call After an additional 4 weeks of adherence data the coordinator will call the participants in the TASC and TAU for their second monthly phone call The coordinator will calculate baseline adherence and obtain data for asthma severity and asthma control for TASC and TAU participants For TASC participants only the coordinator will introduce Step 1 of the intervention for all participants Adherence checks will continue to occur every four weeks for the duration of the study for all participants and adherence 68 will prompt movement from one level of treatment to the next for TASC participants only The study coordinator will calculate TASC participants adherence percentage prior to the monthly telephone call During the call the coordinator will tell the participant if they will get moved up to the next step and explain what they will be doing during that step TASC participants may remain at a treatment level for more than four weeks and may complete 1 2 or 3 interventions steps during the 5 month study depending on the adolescents adherence Brief measures will be completed by all participants online via REDCap Participant specific data such as asthma severity lung function and adherence will be collected through the mobile phone application and via telephone Clinical chart reviews will be conducted by study staff to provide an accurate estimate of lung function and disease severity from the date of consent to the end of study date
All participants will complete baseline questionnaires related to demographic and clinical predictors of adherence and asthma They will be randomized following completion of baseline measures Inhaler adherence caps will also be provided to all participants and utilized for 2 months without feedback to obtain baseline adherence In addition all participants receive a mobile spirometer to track their lung function throughout the study The spirometer connects to an app via Bluetooth This app allows the participant to perform pulmonary function tests PFTs and view the results of these tests such as their forced expiratory volume FEV1 as well as other lung function parameters All participants will be asked to use the spirometer at least once a month when completing study visits over the phone with a study team member Following the baseline visit an 8 week run-in phase will be completed to assess baseline adherence using electronic inhaler monitoring After obtaining 4 weeks of adherence data the coordinator will call the participants in TASC and TAU for their first monthly phone call After an additional 4 weeks of adherence data the coordinator will call the participants in the TASC and TAU for their second monthly phone call The coordinator will calculate baseline adherence and obtain data for asthma severity and asthma control for TASC and TAU participants For TASC participants only the coordinator will introduce Step 1 of the intervention for all participants Adherence checks will continue to occur every four weeks for the duration of the study for all participants and adherence 68 will prompt movement from one level of treatment to the next for TASC participants only The study coordinator will calculate TASC participants adherence percentage prior to the monthly telephone call During the call the coordinator will tell the participant if they will get moved up to the next step and explain what they will be doing during that step TASC participants may remain at a treatment level for more than four weeks and may complete 1 2 or 3 interventions steps during the 5 month study depending on the adolescents adherence Brief measures will be completed by all participants online via REDCap Participant specific data such as asthma severity lung function and adherence will be collected through the mobile phone application and via telephone Clinical chart reviews will be conducted by study staff to provide an accurate estimate of lung function and disease severity from the date of consent to the end of study date
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None