A trial of an electronic pill box with reminders for patients taking treatment for tuberculosis

Cluster randomized trial of a medication monitor in the treatment management of patients with pulmonary tuberculosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35812455

Enrollment

3000

Registered

2016-05-19

Start date

2016-11-01

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Infections and Infestations Tuberculosis

Interventions

This is a cluster randomised non blinded trial. Clusters are defined as a county or district. This is a two armed trial, one intervention arm and one control arm: Intervention arm: Patients are provi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. New pulmonary TB case 2. Gene Xpert-positive and rifampicin-sensitive 3. Patient/family member able to use medication monitor after training 4. Likely to be in the study area for next 18 months; or able to attend the 12 and 18 month follow-up visits after the start of treatment 5. Patient agrees to fixed-dose combination (FDC) 6. Patient is receiving treatment from TB designated hospital or TB dispensary at the county (district) level and treatment management in the community health service centers 7. Receiving daily chemotherapy regimen

Exclusion criteria

Exclusion criteria: 1. Aged <18 years 2. Communication impairment 3. Gene Xpert negative or Gene Xpert positive and rifampicin resistant 4. Travel planned during the intensive phase 5. Tuberculous pleuritis 6. Known to be HIV-positive 7. Custody patients (prison and medicine rehabilitation center) 8. Patients who have been hospitalised continuously for the first two months of treatment Post-enrolment exclusions: 1. Participants whose Gene Xpert result was not known at enrolment and found to either be Gene Xpert-negative or Gene Xpert-positive and rifampicin resistant 2. Participants who stopped taking the Fixed Dose Combination tablets within the first 1 month due to an adverse reaction 3. Participants who permanently stopped the treatment management model within the first 1 month due to, for example, travel, hospitalisation, etc. 4. Participant subsequent found to be HIV-positive Participants satisfying the exclusion criteria listed above will be withdrawn from the study and not contribute to study outcomes.

Design outcomes

Primary

Measure	Time frame
Composite poor outcome* is measured using patient records, laboratory results (culture and smear), chest X-ray results and patient self-report over the 18 month period following enrollment to the study. *The composite poor outcome is defined as any of: death at any time during the approximately six months of TB treatment (abstracted from patient records); loss to follow-up during the approximately six months of TB treatment i.e. treatment was interrupted for two consecutive months or more (abstracted from patient records); treatment failure i.e sputum smear or culture is positive at month 5 or later during the approximately six months of TB treatment (laboratory results abstracted from patient records); microbiological confirmation of TB, or positive chest X-ray findings in absence of microbiological results, at 12 or 18 months after enrollment to the study (laboratory results, based on smear and culture, and chest X-ray findings); or restarting TB treatment between the end of treatment and 18 months after enrollment to the study (patient records and patient self-report).	—

Measure

Time frame

Composite poor outcome* is measured using patient records, laboratory results (culture and smear), chest X-ray results and patient self-report over the 18 month period following enrollment to the study. *The composite poor outcome is defined as any of: death at any time during the approximately six months of TB treatment (abstracted from patient records); loss to follow-up during the approximately six months of TB treatment i.e. treatment was interrupted for two consecutive months or more (abstracted from patient records); treatment failure i.e sputum smear or culture is positive at month 5 or later during the approximately six months of TB treatment (laboratory results abstracted from patient records); microbiological confirmation of TB, or positive chest X-ray findings in absence of microbiological results, at 12 or 18 months after enrollment to the study (laboratory results, based on smear and culture, and chest X-ray findings); or restarting TB treatment between the end of treatment and 18 months after enrollment to the study (patient records and patient self-report).

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Secondary

Measure	Time frame
Clinical outcomes: 1. Poor outcome at the end of treatment (death, treatment failure or loss to follow-up) is measured using patient records and laboratory results (culture and smear) at the end of approximately six months of TB treatment (definitions of death, treatment failure or loss to follow-up are the same as for the primary outcome) 2. Composite poor outcome is measured using patient records, laboratory results (culture and smear), chest X-ray results and patient self-report over the 12 month period following enrollment to the study. Definition the same as for the primary outcome excluding the microbiological confirmation at 18 months and only assessing for restarting of TB treatment between the end of treatment and 12 months after enrollment to the study. 3. Loss to follow-up during the approximately six months of TB treatment i.e. treatment was interrupted for two consecutive months or more (abstracted from patient records), as per standard TB outcome case definitions Adherence outcomes: 1. The percentage of months in which the patient missed at least 20% of doses, measured using data from medication monitor box at each of the approximately monthly follow-up visits during the approximately six months of treatment 2. The percentage of doses missed, measured using data from the medication monitor box monthly at each of the approximately monthly follow-up visits during the approximately six months of treatment Cost-effectiveness outcomes: 1. Mean cost per patient treatment month is measured using financial records, event data from trial CRFs, staff semi-structured interviews and observations, and patient surveys at the end of approximately six months of TB treatment 2. Mean and incremental costs per patient completing treatment is measured using financial records, event data from trial CRFs, staff semi-structured interviews and observations, and patient surveys at the end of approximately six months of TB treatment 3. Mean and incremental costs per death and	—

Measure

Time frame

Clinical outcomes: 1. Poor outcome at the end of treatment (death, treatment failure or loss to follow-up) is measured using patient records and laboratory results (culture and smear) at the end of approximately six months of TB treatment (definitions of death, treatment failure or loss to follow-up are the same as for the primary outcome) 2. Composite poor outcome is measured using patient records, laboratory results (culture and smear), chest X-ray results and patient self-report over the 12 month period following enrollment to the study. Definition the same as for the primary outcome excluding the microbiological confirmation at 18 months and only assessing for restarting of TB treatment between the end of treatment and 12 months after enrollment to the study. 3. Loss to follow-up during the approximately six months of TB treatment i.e. treatment was interrupted for two consecutive months or more (abstracted from patient records), as per standard TB outcome case definitions Adherence outcomes: 1. The percentage of months in which the patient missed at least 20% of doses, measured using data from medication monitor box at each of the approximately monthly follow-up visits during the approximately six months of treatment 2. The percentage of doses missed, measured using data from the medication monitor box monthly at each of the approximately monthly follow-up visits during the approximately six months of treatment Cost-effectiveness outcomes: 1. Mean cost per patient treatment month is measured using financial records, event data from trial CRFs, staff semi-structured interviews and observations, and patient surveys at the end of approximately six months of TB treatment 2. Mean and incremental costs per patient completing treatment is measured using financial records, event data from trial CRFs, staff semi-structured interviews and observations, and patient surveys at the end of approximately six months of TB treatment 3. Mean and incremental costs per death and

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Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026