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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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Mobile Outreach Approach
Sponsored by
Ministry of Health, Saudi Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed TB cases

Exclusion Criteria:

  • Visitors having TB especially pilgrims

Sites / Locations

  • Ministry of Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention arm

Control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Treatment Success rate

Secondary Outcome Measures

Full Information

First Posted
December 24, 2018
Last Updated
December 25, 2018
Sponsor
Ministry of Health, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT03787914
Brief Title
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
Official Title
Community Outreach Mobile Teams Impact on Tuberculosis Treatment Outcome in Jeddah Region: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Saudi Arabia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators conducted a two-arm, parallel design[1:1], single blind randomized control trial in 200 newly diagnosed TB patients
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Control arm patients were given the traditional facility based DOTS treatment. Control arm was not served by the outreach mobile teams.
Intervention Type
Procedure
Intervention Name(s)
Mobile Outreach Approach
Intervention Description
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
Primary Outcome Measure Information:
Title
Treatment Success rate
Time Frame
6 to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed TB cases Exclusion Criteria: Visitors having TB especially pilgrims
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah AlSahafi, MBBS, SBFM
Organizational Affiliation
Director of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Ministry of Health
City
Jeddah
State/Province
Makkah
ZIP/Postal Code
21577
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33490640
Citation
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.
Results Reference
derived

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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

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