- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03121157
Detroit Young Adult Asthma Project (DYAAP)
5. maj 2022 opdateret af: Karen MacDonell, PhD, Wayne State University
Multi-component Technology Intervention for African American Emerging Adults With Asthma
The purpose of the Detroit Young Adult Asthma Project is to test a technology based program to help African American young adults learn to better manage their asthma.
Participants will be randomized to a multi-component technology-based intervention (MCTI) targeting asthma medication adherence or to a comparison control condition.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Racial and ethnic minority youth have poorer asthma status than Caucasian youth, even after controlling for socioeconomic variables.
Proper use of asthma controller medications is critical in reducing asthma mortality and morbidity.
The clinical consequences of poor asthma management include increased illness complications, excessive functional morbidity, and fatal asthma attacks.
There are significant limitations in research on interventions to improve asthma management in racial minority populations, particularly minority adolescents and young adults, though illness management tends to deteriorate after adolescence during emerging adulthood, the unique developmental period beyond adolescence but before adulthood.
All elements of the proposed study protocol were piloted in an NHLBI-funded pilot study (1R34HL107664-01A1 MacDonell).
Results suggested feasibility and acceptability of the study protocol as well as proof of concept.
The intervention is now being tested in a larger randomized clinical trial.
The proposed study will include 192 African American emerging adults with moderate to severe persistent asthma and low controller medication adherence recruited from clinic and emergency department settings.
Half of the sample will be randomized to receive a multi-component technology-based intervention (MCTI) targeting adherence to daily controller medication.
The MCTI consists of two components: 1) 2 sessions of computer-delivered motivational interviewing targeting medication adherence, and 2) individualized text messaging focused on medication adherence between the sessions.
Text messages will be individualized based on Ecological Momentary Assessment (EMA).
The remaining half of participants will complete a series of computer-delivered asthma education modules matched for length, location, and method of delivery of the intervention session.
Control participants will also receive text messages between intervention sessions.
Message content will be the same for all control participants and contain general facts about asthma (not tailored).
Youth will be recruited from the Detroit Medical Center, the only university affiliated medical center in Detroit, Michigan.
It is hypothesized that youth randomized to MCTI will show improvements in adherence to medication (primary outcome) and asthma control (secondary outcome) compared to the comparison condition at all post-intervention follow ups (3, 6, 9, and 12 months).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
192
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Detroit Medical Center/Wayne State University School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 29 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- African American, moderate to severe persistent asthma requiring daily controller medications, live within 30 miles of study site (Detroit area), be able to complete questionnaires in English, must own or have access to a cell for phone for study duration.
Exclusion Criteria:
- Thought disorder (i.e. schizophrenia, autism), suicidality, or mental retardation, youth with other chronic health conditions or pregnancy requiring ongoing medical intervention (e.g., HIV, Type II Diabetes).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
The intervention group will receive two sessions of computer-delivered motivational interviewing via CIAS software programmed to target adherence to medications.
The intervention group will also receive text messaged adherence reminders between sessions.
Both the computer-delivered sessions and text messages will be tailored to the participant using ecological momentary assessment.
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The intervention group receives two sessions of computer-delivered MI via software programmed to target adherence to medications and text messaged adherence reminders between sessions.
Sessions are provided by an avatar.
The intervention engages the youth with the avatar's communication of empathy, optimism, and autonomy support.
The intervention focuses the youth on adherence and relevant health behaviors with feedback on adherence, asthma symptoms, and tailored education.
Participants are guided in the planning process through goal setting activities.
The length of the intervention sessions are about 30 minutes each, with the total duration of the visit (assessment and intervention) lasting about 1.5 hours.
Andre navne:
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Ingen indgriben: Control
Control participants complete CIAS-delivered asthma education modules matched for length, location, and method of delivery of the intervention session.
Control participants complete each module at their own pace and then complete a short quiz to assess their knowledge.
Control participants also receive text messages between intervention sessions.
Message content is the same for all control participants and contains general facts about asthma (not tailored).
Message timing is not tailored and is sent at the same time every day (4:00 PM--time chosen to avoid AM and PM medication times but to not interfere with sleep and school activities).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Medication Adherence
Tidsramme: Change from baseline at 3, 6, and 12 months
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Daily text messaging, Doser, and self-report
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Change from baseline at 3, 6, and 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Asthma Control
Tidsramme: Change from baseline at 3, 6, and 12 months
|
Frequency of asthma symptoms based on self-report
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Change from baseline at 3, 6, and 12 months
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Asthma Control
Tidsramme: Change from baseline at 3, 6, and 12 months
|
Lung functioning as measured by portable spirometer
|
Change from baseline at 3, 6, and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. april 2017
Primær færdiggørelse (Faktiske)
16. februar 2022
Studieafslutning (Forventet)
30. juni 2022
Datoer for studieregistrering
Først indsendt
6. marts 2017
Først indsendt, der opfyldte QC-kriterier
13. april 2017
Først opslået (Faktiske)
20. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01HL133506-01 (U.S. NIH-bevilling/kontrakt)
- R01HL133506 (U.S. NIH-bevilling/kontrakt)
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