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Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy.

13. august 2021 opdateret af: Dr Minh Pham, Griffith Base Hospital

Effect of Enhanced Interactive Text Messages and Phone Instruction on the Quality of Bowel Preparation for Colonoscopy: a Randomised Controlled Trial.

Efficacy Evaluation of Enhanced Bowel Preparation Instructions in Elective Colonoscopy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, randomized, controlled clinical investigation designed to evaluate the efficacy of enhanced bowel preparation instructions (automated SMS, information website, and pre-recorded phone call) in improving bowel preparation quality in elective colonoscopy.

Subjects from the interventional and control group will receive standard of care bowel preparation instruction.

The interventional group will receive enhanced instructions delivered by automated SMS, information website and pre-recorded phone calls in the 48 hours leading up to the colonoscopy day. The intention is to provide a reminder, to reiterate instruction on clear fluid diet and timing of bowel preparation medication, and to provide additional graphical illustration on the information website.

Subjects in the interventional group must reply "OK" to each automated SMS or press "1" on the keypad at the end of the automated phone call to acknowledge understanding and receipt of instruction. Failure to acknowledge trigger an alert for a booking office staff member to directly call the patient and confirm compliance.

The clinical investigation will be conducted at one hospital in the state of New South Wales, Australia.

Subjects will be randomized to the interventional group (enhanced instruction) versus the control group (standard instruction).

The proceduralist assessing outcome measures at the time of colonoscopy is blinded to the intervention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Australien
    • New South Wales
      • Griffith, New South Wales, Australien, 2680
        • Rekruttering
        • Griffith Base Hospital
        • Kontakt:

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Elective colonoscopy booking at Griffith Base Hospital.

Exclusion Criteria:

  • Emergency colonoscopy
  • Patients who are unable to understand bowel preparation instructions in the following languages: English, Italian, Punjabi, Gujarati, Samoan, Mandarin.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard Bowel Preparation Instruction
Patients receive the standard-of-care bowel preparation instruction.
Eksperimentel: Enhanced Bowel Preparation Instruction
Patients receive enhanced instructions (SMS, phone call, info website) in addition to the standard-of-care bowel preparation instruction.
Andet: Enhanced bowel preparation instruction
Automated delivery of SMS, pre-recorded phone call, and link to an information website.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bowel preparation quality
Tidsramme: Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (range 0 to 9, with higher scores indicating better bowel preparation quality)
Bowel preparation quality is scored once for each patient at the time of colonoscopy completion. We expect to conduct this score in 500 patients over the study period of approximately 12 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Colonoscopy cancellation rate
Tidsramme: Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
The number of colonoscopy being cancelled within 48 hours of the colonoscopy date. The rates will be compared between the study groups.
Colonoscopy cancellation rate will be calculated at the time of study completion, expected to be 12 months.
Caecal intubation rate
Tidsramme: Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
The proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon. The rates will be compared between the study groups.
Caecal intubation rate will be calculated at the time of study completion, expected to be 12 months.
Polyp detection rate
Tidsramme: Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.
The proportion of colonoscopies in which a polyp was detected. The rates will be compared between the study groups.
Polyp detection rate will be calculated at the time of study completion, expected to be 12 months.

Samarbejdspartnere og efterforskere

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

Sponsor

Griffith Base Hospital

Efterforskere

  • Ledende efterforsker: Minh Pham, Researcher

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.

Generelle publikationer

Hjælpsomme links

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)

13. august 2021

Primær færdiggørelse (Forventet)

1. februar 2022

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

11. maj 2021

Først indsendt, der opfyldte QC-kriterier

18. maj 2021

Først opslået (Faktiske)

24. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GriffithBH

Plan for individuelle deltagerdata (IPD)

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Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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