Effect of Community Mobile Outreach Approach Compared to Facility Based Directly Observed Treatment Short Course on Treatment Outcome Among Tuberculosis Patients in Jeddah: A Randomized Controlled Trial

NCT ID: NCT03787914

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-11-01

Brief Summary

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To compare the effectiveness of the community mobile outreach approach in improving treatment outcomes (success rate) among tuberculosis patients with those being treated with facility based directly observed treatment short course (DOTS) in Jeddah region.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators conducted a two-arm, parallel design\[1:1\], single blind randomized control trial in 200 newly diagnosed TB patients
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention arm

Intervention arm patients were served by outreach mobile teams for oral anti-TB treatment under DOTS at the place of their convenience by health care professionals

Group Type EXPERIMENTAL

Mobile Outreach Approach

Intervention Type PROCEDURE

TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision

Control arm

Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams.

Group Type ACTIVE_COMPARATOR

Mobile Outreach Approach

Intervention Type PROCEDURE

TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision

Interventions

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Mobile Outreach Approach

TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed TB cases

Exclusion Criteria

* Visitors having TB especially pilgrims
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Saudi Arabia

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hassan Bin Usman

Public Health Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdullah AlSahafi, MBBS, SBFM

Role: STUDY_DIRECTOR

Director of Public Health

Locations

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Ministry of Health

Jeddah, Mecca Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Al-Sahafi A, Al-Sayali MM, Mandoura N, Shah HBU, Al Sharif K, Almohammadi EL, Abdul-Rashid OA, Assiri M, Buksh MF, Alali MM, Al-Garni A, Al-Garni F, Al-Zahrani A, Khalawi A, Alawi M, Moawwad AL, Almalki AIA, Al-Osaimi MM. Treatment outcomes among tuberculosis patients in Jeddah, Saudi Arabia: Results of a community mobile outreach directly observed Treatment, Short-course (DOTS) project, compared to a standard facility-based DOTS: A randomized controlled trial. J Clin Tuberc Other Mycobact Dis. 2020 Dec 31;22:100210. doi: 10.1016/j.jctube.2020.100210. eCollection 2021 Feb.

Reference Type DERIVED
PMID: 33490640 (View on PubMed)

Other Identifiers

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H-02-J-002-00877

Identifier Type: -

Identifier Source: org_study_id