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Influence of Data Collection Mode on Self-Report Validity of Asthma Therapy Adherence

11. december 2017 opdateret af: Johns Hopkins University

Assessment Mode and Validity of Self-Reports in Adults

This study will examine how the assessment mode influences the validity of self-reported adherence to asthma therapy. Self-reported adherence to asthma therapy data will be collected using one of three randomized assessment modes (interview, computer, or telephone).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Adfærdsmæssigt: Standardized Asthma Education Program

Detaljeret beskrivelse

BACKGROUND:

Self-reports are a primary source of behavioral data. Studies have highlighted the variable validity and reliability of self-report measures of health behaviors such as adherence to therapy. Research on self-reports of sensitive information, such as sexual behavior and drug use, suggests that the mode of data collection may enhance validity of self-reports. However, no studies have determined how the mode of data collection influences self-reports when an objective measure of the behavior is available.

DESIGN NARRATIVE:

The primary aim of this study is to examine the influence of the mode of data collection on the validity of self-reports of inhaled anti-inflammatory medication adherence.

The key secondary outcomes of the study will attempt to answer the following questions: 1) does the assessment mode influence self-reports of commonly used asthma outcome measures of disease-related symptoms, self-management behaviors, and quality of life?; 2) does the relationship between the assessment mode, the validity of self-reports of adherence, and other measures (i.e., asthma symptoms, self-management behaviors, and quality of life) change over time?; and 3) does the assessment mode interact with baseline personality characteristics and mood to influence the validity of self-reports of adherence and other outcome measures (i.e., asthma symptoms, self-management behaviors, and quality of life)?

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

139

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21224
    - Johns Hopkins University

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

19 år til 95 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Diagnosis of asthma
Under a provider's care for asthma
Prescribed daily inhaled corticosteroids (by metered dose inhaler [MDI]) at least 2 times a day
Speaks English
Otherwise in good general health

Exclusion Criteria:

N/A

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Tildeling: Randomiseret

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Concordance between patient's self-reported medication adherence and electronically measured adherence Tidsramme: Measured at Months 1 through 5	Measured at Months 1 through 5

Sekundære resultatmål

Resultatmål	Tidsramme
Impact of mode of assessment on adult self-reports of asthma symptoms, asthma management practices, and quality of life Tidsramme: Measured at Months 1 through 5	Measured at Months 1 through 5
Relationship between baseline measures of psychosocial variables (i.e., personality and mood) and the primary outcome Tidsramme: Measured at Months 1 through 5	Measured at Months 1 through 5

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johns Hopkins University

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

Ledende efterforsker: Cynthia Rand, PhD, Johns Hopkins University

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

1. august 2002

Primær færdiggørelse (Faktiske)

1. maj 2005

Studieafslutning (Faktiske)