Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03787914
Recruitment Status : Completed
First Posted : December 26, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hassan Bin Usman, Ministry of Health, Saudi Arabia

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Procedure: Mobile Outreach Approach Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The investigators conducted a two-arm, parallel design[1:1], single blind randomized control trial in 200 newly diagnosed TB patients
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community Outreach Mobile Teams Impact on Tuberculosis Treatment Outcome in Jeddah Region: A Randomized Controlled Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: 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
Procedure: 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

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




Primary Outcome Measures :
  1. Treatment Success rate [ Time Frame: 6 to 8 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed TB cases

Exclusion Criteria:

  • Visitors having TB especially pilgrims

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787914


Locations
Layout table for location information
Saudi Arabia
Ministry of Health
Jeddah, Makkah, Saudi Arabia, 21577
Sponsors and Collaborators
Ministry of Health, Saudi Arabia
Investigators
Layout table for investigator information
Study Director: Abdullah AlSahafi, MBBS, SBFM Director of Public Health

Layout table for additonal information
Responsible Party: Hassan Bin Usman, Public Health Specialist, Ministry of Health, Saudi Arabia
ClinicalTrials.gov Identifier: NCT03787914     History of Changes
Other Study ID Numbers: H-02-J-002-00877
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections