Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia (DOTS)
Primary Purpose
Tuberculosis, Pulmonary
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Intramural
Extramural
Sponsored by
About this trial
This is an interventional health services research trial for Tuberculosis, Pulmonary focused on measuring Tuberculosis, Adherence, medication, Patient compliance
Eligibility Criteria
Inclusion Criteria:
- Male and female (non-pregnant)
- 15 years of age and older
- Living in urban area (Cali)
- New diagnosed patients (TB)
- In conditions to give survey information
- Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis
Exclusion Criteria:
- Not written informed consent
Sites / Locations
- Secretaria de Salud Publica Municipal de Cali
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extramural
Intramural
Arm Description
Extramural medication delivery and supervision
Intramural medication delivery and supervision
Outcomes
Primary Outcome Measures
Compliance with treatment
Total of patients who completed de treatment
Secondary Outcome Measures
Cured patients
Total number of patients who completed the treatment and had the last or the two last smear negative and had negative cultures at the end of the treatment
Full Information
NCT ID
NCT01945905
First Posted
September 9, 2013
Last Updated
August 10, 2015
Sponsor
Fundación FES
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Salud Publica, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01945905
Brief Title
Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia
Acronym
DOTS
Official Title
Cost-effectiveness of Two Forms of Delivery of Directly Observed Treatment in a Demonstration Area of the DOTS Strategy in Colombia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación FES
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Instituto Nacional de Salud Publica, Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tuberculosis ( TB ) remains a major global public health problems and actions to ensure the diagnosis and complete treatment of all cases is the priority for the control of this disease. Despite the availability of effective anti-tuberculosis medications, there are still high levels of nonadherence to treatment. The nonadherence increases the morbidity and mortality of patients, decreases the cure rate, increases the community transmission and the increase of chronically ill patients enables the emergence of multi - drug resistant and increases treatment costs.
Despite the knowledge about different forms of cost-effective delivery of DOT (directly observed treatment), recognition of the need to establish the DOT strategy related to the context from local studies, in Colombia and in Cali we hadn't had made studies similar than this one that establish the cost and results of the current DOT delivery strategy and to identify other ways to improve adherence and cure rate for the TB patients at reasonable cost for both: health services and families
Therefore, this research aims to compare the cost -effectiveness of current DOT delivery method with an alternative extra- institutional delivery of anti -TB treatment in urban areas of Cali. A cost-effectiveness study was conducted from the institutional and familiar perspective with prospective information collection.
Detailed Description
We compared two strategies for anti- TB treatment delivery: one institutional in which patients went to health institutions to receive treatment and other extra- institutional in which the medication was delivered in the place of choice for treating patients.
Measuring the effectiveness ( compliance and cure ) was made from a controlled clinical trial , randomized , partially blinded . The measurement of family and institutional costs , direct and indirect , will be based on the activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
Keywords
Tuberculosis, Adherence, medication, Patient compliance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extramural
Arm Type
Experimental
Arm Description
Extramural medication delivery and supervision
Arm Title
Intramural
Arm Type
Active Comparator
Arm Description
Intramural medication delivery and supervision
Intervention Type
Other
Intervention Name(s)
Intramural
Intervention Description
Under this alternative, the patients will receive treatment with direct observation from health team. Treatment will be provided for free
Intervention Type
Other
Intervention Name(s)
Extramural
Intervention Description
In this form the medication will be given by a health worker in the place chosen by patients. This option will be delivered to patients with newly diagnosed pulmonary TB without hospitalization criteria
Primary Outcome Measure Information:
Title
Compliance with treatment
Description
Total of patients who completed de treatment
Time Frame
Participants will be followed for the duration of the treatment, an expected average of six months
Secondary Outcome Measure Information:
Title
Cured patients
Description
Total number of patients who completed the treatment and had the last or the two last smear negative and had negative cultures at the end of the treatment
Time Frame
Participants will be followed for the duration of the treatment, an expected average of six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female (non-pregnant)
15 years of age and older
Living in urban area (Cali)
New diagnosed patients (TB)
In conditions to give survey information
Patients without hemoptysis and special conditions like: hepatic disease, renal failure, diabetes, hypertension, HIV/AIDS and negative test for pulmonary tuberculosis
Exclusion Criteria:
Not written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra L Giron, Msc Epi
Organizational Affiliation
Fundación FES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio C Mateus, Msc Epi
Organizational Affiliation
Fundación FES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Secretaria de Salud Publica Municipal de Cali
City
Cali
State/Province
Valle
ZIP/Postal Code
76001000
Country
Colombia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19275807
Citation
Moulding T, Mateus-Solarte JC, Carvajal-Barona R. Factors predictive of adherence to tuberculosis treatment, Valle del Cauca, Colombia. Int J Tuberc Lung Dis. 2009 Mar;13(3):416-7; author reply 417-8. No abstract available.
Results Reference
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PubMed Identifier
9217566
Citation
Pablos-Mendez A, Knirsch CA, Barr RG, Lerner BH, Frieden TR. Nonadherence in tuberculosis treatment: predictors and consequences in New York City. Am J Med. 1997 Feb;102(2):164-70. doi: 10.1016/s0002-9343(96)00402-0.
Results Reference
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PubMed Identifier
9149565
Citation
Burman WJ, Cohn DL, Rietmeijer CA, Judson FN, Sbarbaro JA, Reves RR. Noncompliance with directly observed therapy for tuberculosis. Epidemiology and effect on the outcome of treatment. Chest. 1997 May;111(5):1168-73. doi: 10.1378/chest.111.5.1168.
Results Reference
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PubMed Identifier
11936739
Citation
O'Boyle SJ, Power JJ, Ibrahim MY, Watson JP. Factors affecting patient compliance with anti-tuberculosis chemotherapy using the directly observed treatment, short-course strategy (DOTS). Int J Tuberc Lung Dis. 2002 Apr;6(4):307-12.
Results Reference
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PubMed Identifier
12828545
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Cost-effectiveness of Two Forms of DOTS in a Demonstration Area of the DOTS Strategy in Colombia
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