Pulmonary tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
After recruitment, randomization will be conducted using the computer random list generated by STATA 15.0 software. A 1:1 ratio of patients will be randomly assigned to the intervention group or the c
Sponsors
National Natural Science Foundation of China
Natural Science Foundation of Inner Mongolia
Eligibility
Sex/Gender
All
Age
15 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The study sample will consist of patients who have been diagnosed in the TB dispensary following national and international care guidelines and who are beginning a typical 6-month short course of chemotherapy in community health centers or township hospitals. 2. TB patients must satisfy the following requirements to be considered eligible: 2.1. Aged 15 years or over 2.2. No speech, mental, visual, auditory, or other communication impairments 2.3. No family member residing in the same household who has already been enrolled in the trial
Exclusion criteria
Exclusion criteria: 1. Patients’ age is less than 15 years old 2. Have communication impairments, such as speech, mental, visual, auditory, etc 3. Having any family member residing in the same household who has already been enrolled in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment adherence calculated from monthly level data for each patient indicating the number of doses taken per month. The researchers will identify treatment adherence =80% as high adherence, otherwise it is non-adherence. Treatment adherence is measured every month during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 6, 12, 18, 24, 30, and 36 months: 1. Treatment completion rate, as defined by the WHO standard definitions: a TB patient who finished treatment without having evidence of treatment failure, but who did not have negative sputum smear or culture results in at least one prior instance or in the final month of treatment, either because the tests were not conducted or the results were not available 2. Loss to follow-up rate, as defined by the WHO standard definitions: a TB patient who did not initiate treatment or whose treatment was interrupted for two consecutive months or more 3. Treatment failure, as defined by the WHO standard definitions: a TB patient who received treatment and had positive results from a sputum smear or culture at month five or later 4. Death, as defined by the WHO standard definitions: a TB patient who passed away before starting treatment or while receiving it, for any reason Based on the RE-AIM framework, the impact of the optimized EM program is also assessed in comparison to standard care for the subsequent secondary outcome measures at baseline, 6, 12, 18, 24, 30, and 36 months: 5. Reach: the quantity and percentage of TB patients who participate in the medication e-monitoring program, as well as their motivations for doing so 6. Effectiveness: the effects of the improved e-monitoring program on TB treatment outcomes, treatment adherence, and financial outcomes 7. Adoption: the number of TB patients enrolled in the optimized e-monitoring program, the number of primary care providers enrolled in the optimized e-monitoring program, and the acceptance level of the optimized e-monitoring program among directors from primary care facilities and CDC 8. Implementation: 8.1. Fidelity: the extent to which the optimized e-monitoring program is implemented as per the original protocol 8.2. Feasibility: the extent to which the optimized e-monitoring program can be implemented in a specific setting 8.3. Outer context: macro-level e | — |
Countries
China
Outcome results
None listed