NCT04745897

Brief Summary

The World Health Organization's Global Tuberculosis Programme (WHO-GTB) issues evidence-informed guideline recommendations on tuberculosis (TB). These recommendations are used by decision-makers, guideline developers and other stakeholders. In an effort to improve the accessibility and usability of these recommendations, a new eTB catalogue of recommendations has been developed. This study aims to compare the accessibility of the new eTB catalogue to the earlier method of accessing recommendations directed through the general WHO website.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 26, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2021

Completed
Last Updated

December 13, 2021

Status Verified

December 1, 2021

Enrollment Period

6 months

First QC Date

February 4, 2021

Last Update Submit

December 9, 2021

Conditions

Keywords

GRADEGuidelinesRecommendationsRecommendation MappingEvidence Mapping

Outcome Measures

Primary Outcomes (1)

  • Accessibility of Information on a Seven-Point Likert Scale

    The primary outcome is the accessibility of information on the eTB catalogue compared to the current WHO TB guidelines. Accessibility is defined as the ability to access and use information. This outcome considers the four following domains: (1) how easy is it to find the information (2) how easy is it to understand the information (3) whether the presentation of this information facilitates decision-making (4) overall accessibility of information. These domains will be measured using a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree). The statements will be: 'It was easy to find the information', 'it was easy to understand the information', 'the information was presented in a way that would help me make a decision', and 'this website was easy to navigate'. The investigators will calculate mean composite values of these four domains for the primary outcome of accessibility, and present the four individual domains as secondary outcomes.

    Duration of survey (approximately 10 minutes)

Secondary Outcomes (3)

  • Satisfaction on a Seven-Point Likert Scale

    Duration of survey (approximately 10 minutes)

  • Understanding with Multiple Choice Questions

    Duration of survey (approximately 10 minutes)

  • Preference on a Seven-Point Likert-Scale

    Duration of survey (approximately 10 minutes)

Study Arms (2)

eTB Catalogue of Recommendation (eTB)

EXPERIMENTAL

New eTB catalogue of recommendations website (eTB).

Other: eTB Catalogue of Recommendations (eTB)

World Health Organization Tuberculosis Website (WHO TB)

ACTIVE COMPARATOR

Current method of accessing tuberculosis (TB) recommendations using World Health Organization (WHO) website (WHO TB).

Other: World Health Organization Tuberculosis Website (WHO TB)

Interventions

eTB Catalogue of Recommendations (eTB)

eTB Catalogue of Recommendation (eTB)

World Health Organization Tuberculosis Website (WHO TB)

World Health Organization Tuberculosis Website (WHO TB)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stakeholders who consider themselves to be users or potential users of tuberculosis (TB) recommendations will be eligible for participation. For the purposes of this trial, a user is defined as someone who has previously accessed TB guidelines, recommendations or policy advice, and a potential user is someone who plans to access TB guidelines, recommendations, or policy advice in the future.
  • Participants may be part of any group that has a stake in TB, including the public, healthcare providers, policymakers, or researchers. Participants may be from either low- and middle-income countries (LMIC) or high-income countries (HIC).
  • They may also vary in levels of education and previous TB work experience.

You may not qualify if:

  • Individuals involved in eTB catalogue development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Publications (1)

  • Matthews M, Lotfi T, Santesso N, Loeb M, Mertz D, Chagla Z, Hajizadeh A, Piggott T, Dietl B, Schunemann HJ. Comparing the usability of the World Health Organization's conventional tuberculosis guidelines to the eTB recommendations map: A two-arm superiority randomised controlled trial. PLOS Glob Public Health. 2022 Oct 14;2(10):e0001166. doi: 10.1371/journal.pgph.0001166. eCollection 2022.

Related Links

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Holger J Schunemann, MD, PhD

    McMaster University

    STUDY CHAIR
  • Micayla N Matthews, BHSc

    McMaster University

    PRINCIPAL INVESTIGATOR
  • Tamara Lotfi, MD, MPH

    McMaster University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

February 26, 2021

Primary Completion

August 29, 2021

Study Completion

August 29, 2021

Last Updated

December 13, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations