- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00794170
Interactive Study to Increase Glaucoma Adherence to Treatment (I-SIGHT)
9. maj 2014 opdateret af: Karen Glanz, MD, Emory University
I-SIGHT: Interactive Study to Increase Glaucoma adHerence to Treatment Phase 2: Participant Recruitment & Intervention Delivery and Evaluation
Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma treatment compliance (e.g., medication-taking and refill compliance, return for clinical follow-up) and more positive eye health outcomes at 12-month follow-up than participants who receive the control group intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The intervention is telephone-based and individually-tailored to participants' compliance knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy; race and culture; and prescribed medication regimen.
The intervention calls utilize interactive voice recognition technology to facilitate interest, participation, and interaction with call recipients.
We evaluated the intervention in a randomized controlled trial with telephone interviews administered to all participants at baseline, 6, 9, and 12-months
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
312
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30303
- Grady Health System
-
Atlanta, Georgia, Forenede Stater, 30033
- Atlanta VA Medical Center
-
-
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 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Receive treatment at the Atlanta VA Medical Center or Grady Eye clinic for their eye condition
- Be between the ages of 18-80
- Be Caucasian or African American
- Possess a telephone (home telephone or cellular phone)
- Speak and understand English
- Be diagnosed with open angle glaucoma, be glaucoma suspect, or be ocular hypertensive for at least one year
- Be prescribed daily doses of topical treatments for at least one year
- Be able to read or have someone who can help the participant with reading written materials that we give to the participant
Exclusion Criteria:
- Having eye surgery within 3 months of baseline interview and enrollment
- Being legally blind (20/200 or worse)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telephone and print based intervention
The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call.
The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews.
The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support.
The treatment group receives the tailored telephone intervention and mailed, printed materials.
|
Thiss intervention consisted of tailored phone calls and follow-up mailings.
|
Ingen indgriben: Usual care
The control group received usual care at each clinical site and interacted with study personnel only for data collection.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Data on Prescription Drug Renewals, Appointment Compliance and Medication Taking (e.g. Physician Notes)
Tidsramme: Baseline and 12 months
|
The adherence measure, developed and pilot tested by the I-SIGHT study team, assessed compliance adherence with medication taking, refills, and appointment-keeping by self-report and chart review.
Subjects were considered nonadherent with medication-taking if they reported missing doses of any glaucoma medication within one month of the interview.
Levels of medication-taking nonadherence were also examined by missed doses within 7 days, 2 weeks, or 1 mo of the interview.
Nonadherence with refills was defined as running out of any glaucoma medication and missing a dose within a specified time frame (i.e. 1 year prior to the baseline interview; 6 months prior to 6-month interview; and 3 months prior to the 9 and 12 month interview).
Appointment-keeping nonadherence was indicated by self-report of missing a glaucoma treatment appointment and not rescheduling during the specified time frame.
Self-report of nonadherence in any of these three areas classified the subject as nonadherent.
|
Baseline and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Karen Glanz, PhD, MPH, Emory University
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
1. august 2008
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. september 2010
Datoer for studieregistrering
Først indsendt
17. november 2008
Først indsendt, der opfyldte QC-kriterier
18. november 2008
Først opslået (Skøn)
19. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juni 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB00001335
- R01EY016997 (U.S. NIH-bevilling/kontrakt)
- I-SIGHT (Anden identifikator: Other)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Telephone and Print based intervention
-
University of PaviaUniversità degli Studi di BresciaAfsluttetMentalt velværeItalien
-
Stockholm UniversityKarolinska Institutet; Region Stockholm; Centrum för kompetensutveckling... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Washington University School of MedicineSpinal Cord Injury/Disease Research ProgramAfsluttet
-
University of Nevada, Las VegasIkke rekrutterer endnuPost traumatisk stress syndrom
-
University of California, Los AngelesBrown University; Asociación Civil Impacta Salud y Educación, Peru; The Fenway...Afsluttet
-
Necmettin Erbakan UniversityAfsluttetVaccine tøven | BarndomsvaccinationKalkun
-
University of SheffieldPrincess Nourah Bint Abdulrahman UniversityAfsluttetSpiseforstyrrelse symptom og kropsbillede utilfredshedSaudi Arabien
-
Albert Einstein College of MedicineHealth Resources and Services Administration (HRSA); The New SchoolAfsluttetVold i hjemmet | BørnemishandlingForenede Stater
-
Stanford UniversityAnonymous DonorRekrutteringAutismespektrumforstyrrelse | Autisme | ASDForenede Stater