Technology-Assisted Stepped Care Study (TASC Phase 3)
9 maart 2022 bijgewerkt door: Children's Hospital Medical Center, Cincinnati
Technology Assisted Stepped Care (TASC): Phase 3
The overall goal of this project is to demonstrate the feasibility, implementation, and preliminary efficacy of a technology-assisted stepped care (TASC) adherence-promotion intervention in adolescents with asthma.
This is the third phase (Phase 3) of a three-phase project to test the preliminary efficacy of a technology-assisted stepped care (TASC) intervention.
In Phase 1, we developed the intervention using patient and provider feedback from focus groups.
In Phase 2 we refined the developed intervention by having five adolescents from the focus groups test the intervention for feasibility.
In this third phase, we will enroll up to 50 adolescents to pilot-test the refined intervention for preliminary efficacy.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Up to fifty adolescents with asthma will be enrolled in an open label pilot trial of the TASC adherence-promotion intervention for a duration of twelve months.
First, participants will complete baseline questionnaires related to demographic, and clinical predictors of adherence and asthma and a 4 week run-in phase to assess baseline adherence using electronic inhaler monitoring with a cellphone that is provided to them.
Following the run-in period, all participants will receive Step 1 of the TASC intervention for a minimum of 4 weeks.
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.
Following the initial four weeks of Step 1, adherence will be evaluated and a rate of less than 68% will serve as the cause for "stepping up" to the next level of the intervention.
Adherence checks will continue to occur every four weeks for the duration of the study and adherence <68% will prompt movement from one level of treatment to the next.
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 adolescent's adherence.
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 cellphone 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.
The primary outcome measure will be electronically-monitored adherence assessed at post-treatment.
Secondary outcomes include asthma severity as well as process evaluation questions and quantitative measures of feasibility, acceptability, and satisfaction to demonstrate implementation.
Participants will remain in the study for an additional 7 months after they complete month 5 of the study.
For the remaining 7 months, participants will be randomized to one of two booster session patterns with the goal to improve inhaler adherence.
The statistician will make the randomization schedule and the principle investigator will maintain the randomization schedule.
Two different booster patterns are being used to test which pattern will be most effective.
The first booster session pattern will include booster sessions at the end of month 6, 8, and 12.
The second booster session pattern will include booster sessions at the end of month 6, 7, 8, 10, and 12. Booster sessions will review content provided during the intervention and the intervention delivery method will be consistent with the participants final intervention step.
Participants will also continue to complete monthly check-ins with the study coordinator to complete the Composite Asthma Severity Index, the Asthma Control Test, and a spirometry test.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229
- Cincinnati Children's Medical Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
12 jaar tot 18 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Exclusion Criteria:
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review.
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis)
- Patient receives school administered daily controller medication at the time of the enrollment visit
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: TASC-interventie
Alle deelnemers krijgen stap 1 van de interventie.
Deelnemers die een therapietrouw van minder dan of 68% hebben, stappen na de derde of vierde maand van het onderzoek over naar stap 2 of stap 3.
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Stap 1 van de interventie omvat educatief materiaal met betrekking tot astma.
Stap 2 omvat elektronische monitoring van de therapietrouw en een sms-interventie persoonlijk op maat van de deelnemer.
Stap 3 omvat probleemoplossende telehealth-sessies met een getrainde clinicus.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Electronic Monitoring
Tijdsspanne: 12 months
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The Propeller Health monitoring system includes a Bluetooth enabled sensor that attaches to the patient's inhaler.
This sensor records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff.
Participants will be given this sensor at baseline.
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Haalbaarheids-/aanvaardbaarheidsvragenlijst
Tijdsspanne: 5 maanden
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Aan het einde van elke stap en aan het einde van het onderzoek wordt aan de deelnemers een vragenlijst van 5 tot 31 items gegeven voor de vorm, inhoud, duur, vaardigheden en aanvaardbaarheid van de interventie.
Het haalbaarheidsgedeelte is op een schaal van 0 tot 4, waarbij 0 het slechtste is en 4 het beste.
De aanvaardbaarheidsvragenlijst loopt van 'helemaal niet' tot 'zeer', waarbij 'helemaal niet' de slechtste is en 'zeer' de beste.
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5 maanden
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Schaal voor bruikbaarheid van het systeem
Tijdsspanne: 5 maanden
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Aan het einde van elke stap en aan het einde van het onderzoek wordt aan de deelnemers een Likert-schaal van 10 items gegeven die een globaal beeld geeft van de bruikbaarheid.
De schaal loopt van 'Helemaal mee oneens' tot 'Helemaal mee eens, waarbij de helft van de items omgekeerd werd gescoord.
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5 maanden
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Lung Function Assessment
Tijdsspanne: Baseline assessment and then once a month for 12 months
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The mobile spirometer records multiple parameters of the patient's lung function including forced expiratory volume, peak expiratory flow, forced vital capacity, and forced expiratory flow.
The spirometer sends the values to the corresponding mobile phone application, Propeller Health, which is directly accessible to the patient.
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Baseline assessment and then once a month for 12 months
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Composite Asthma Severity Index (CASI)
Tijdsspanne: Baseline assessment and then once a month for 12 months
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The participants' composite asthma severity index score will be calculated through the TreatSmart program.
TreatSmart will be used to determine the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use to determine the level of asthma severity/control the participant has.
The program also makes an initial treatment recommendation based on the National Asthma Education and Prevention Program (NAEPP asthma guidelines).
Individuals are placed in Step 1 through Step 6 depending on the strength and frequency of their inhaled corticosteroid (1 being low dose and 6 being a high dose).
In addition, individuals are categorized as very poorly controlled, not well controlled, or well controlled based on how frequently they have had asthma symptoms or used their rescue inhaler, gone to the hospital or urgent care, or received steroids for asthma symptoms.
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Baseline assessment and then once a month for 12 months
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Asthma Control Test (ACT)
Tijdsspanne: Baseline assessment and then once a month for 12 months
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The ACT will be used as a measure of disease severity in this study.
The ACT is a 5-question scoring tool designed for patients with asthma who are 12 years and older.
The questions ask the patient to rate their asthma severity, symptom frequency, control, and inhaler use on a scale of 1-5.
The total score is calculated by the sum of each response, which determines how well-controlled the patient's asthma is on a scale from 5-25.
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Baseline assessment and then once a month for 12 months
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Attendance/Participation rates
Tijdsspanne: 12 months
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Participation rates will be measured 3 different ways.
The first measure will be how often participants accessed the electronic material (educational materials and/or Propeller Health app), the second measure will be how many responses to directive text messaging were received, and the third measure will be attendance to the telehealth sessions.
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12 months
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Acceptability of Intervention Measure (AIM)
Tijdsspanne: At 5 months
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A 4 item measure of participants' belief that the intervention is acceptable will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Intervention Appropriateness Measure (IAM)
Tijdsspanne: At 5 months
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A 4 item measure of participants' perception that the intervention is appropriate will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Feasibility of Intervention Measure (FIM)
Tijdsspanne: At 5 months
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A 4 item measure of participants' belief that the intervention is feasible will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Treatment Fidelity
Tijdsspanne: 12 months
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Treatment fidelity needed for the intervention will be assessed.
Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session.
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12 months
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Time Needed for Intervention
Tijdsspanne: 12 months
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Sessions will be timed and the number of weeks to complete the session will be tracked to determine the average length of time needed for the intervention.
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12 months
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Perceived Characteristics of Intervention Scale
Tijdsspanne: At 12 months
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19 item measure of interventionist views toward the study intervention.
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At 12 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A
Tijdsspanne: Baseline assessment and at 5 months
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The BASC-3 is a widely used, reliable (α= 0.94 - 0.96 , test-retest r= 0.81 -0.82), and valid inventory to assess emotional and behavioral symptoms in adolescents and young adults (ages 13-21).
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Baseline assessment and at 5 months
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Adolescent Barriers to Medication Scales (AMBS)
Tijdsspanne: Baseline Assessment
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The AMBS is an 18-item validated measure of perceived barriers to medication adherence in adolescents.
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface)
Tijdsspanne: Baseline assessment and then at 2 months
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A 15- item measure of participant's competence, autonomy, and relatedness in using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Autonomy and Competence in Technology Adoption Questionnaire (ACTA)
Tijdsspanne: Baseline Assessment
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A 10-item measure of why people adopt use of a technology (i.e.
download an app, register with a website, purchase a wearable device, etc.).Participants respond to self-regulation statements on a scale of 1 to 5, 1 being 'not at all true' and 5 being 'very true.'
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- Task)
Tijdsspanne: Baseline assessment and then at 2 months
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An 8-item measure of participant's competence, autonomy, and relatedness in managing their asthma using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Technology Effects on Need Satisfaction in Life (TENS- Life)
Tijdsspanne: Baseline assessment and then at 2 months
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The TENS-Life is a 10- item measure of the extent to which a user perceives that the use of a particular technology has had an influence on the satisfaction of basic psychological needs in their life.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Kennisvragenlijst
Tijdsspanne: Basisbeoordeling
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Een vragenlijst met 13 items die de kennis van het individu over astmasymptomen, triggers en medicijnen beoordeelt.
Deelnemers beoordelen hun mate van overeenstemming met elke stelling op een schaal van 'Helemaal mee eens' tot 'Helemaal mee oneens'.
Deze vragenlijst wordt tijdens het nulbezoek ingevuld.
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Basisbeoordeling
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Vragenlijst over ontberingen
Tijdsspanne: Basisbeoordeling
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Een gevalideerde vragenlijst met 19 items die de financiële druk van individuen binnen een huishouden beoordeelt.
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Basisbeoordeling
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
7 december 2018
Primaire voltooiing (Werkelijk)
20 april 2021
Studie voltooiing (Werkelijk)
20 april 2021
Studieregistratiedata
Eerst ingediend
8 februari 2019
Eerst ingediend dat voldeed aan de QC-criteria
19 maart 2019
Eerst geplaatst (Werkelijk)
21 maart 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
9 maart 2022
Laatst geverifieerd
1 maart 2022
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CIN001- {"TASC Phase 3"}
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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