Skip to content

Using electronic monitors and a smartphone app to improve treatment adherence of new pulmonary tuberculosis patients in Tibet, China

Improving new pulmonary tuberculosis (TB) patients’ treatment adherence through electronic monitors and a smartphone app in Tibet: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52132803
Enrollment
300
Registered
2018-11-09
Start date
2018-11-26
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

Pulmonary tuberculosis Infections and Infestations Respiratory tuberculosis, bacteriologically and histologically confirmed

Interventions

Patients will be randomized to either the intervention or control arms in a 1:1 ratio at the time of their diagnosis using an envelope with a computer-generated randomized number. In both the interv
2) patients and/or their family members will be invited to set up the WeChat, a mobile social software, using their smart phones, and connect with their TB doctor and treatment supervisors
3) a family supporter will be selected in consultation of the patient. The supporter will provide psychological support, and help patients use smartphone or WeChat. The supporter will be chosen from t
4) patients will receive continuing support from the family supporter, village doctor/ treatment supervisor, and doctors through WeChat
5) patients will be opted to receive video observed treatment (VOT) when adherence is poor or problematic. Healthcare workers in

Sponsors

Shigatse Centre for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed pulmonary TB patients that is managed at outpatients 2. Aged 15 years or older

Exclusion criteria

Exclusion criteria: 1. Having communication impairment (mental, visual, auditory or speech) 2. Having any family members living in the same household that have already been enrolled into the trial

Design outcomes

Primary

MeasureTime frame
Rate of poor adherence measured per month across the 6/7 months of standard WHO DOTS program for new pulmonary TB patients. It will be calculated from monthly-level data for each patient indicating the number of doses missed per month, with poor monthly adherence defined as the patient having missed =20% of doses per month (equivalent to missing =6 out of 30 doses in a month).

Secondary

MeasureTime frame
1. The patient-level percentage of total doses missed over 6/7 months of treatment (calculated as a percentage value for each patient based on the total number of doses missed out of the total possible number of doses), measured using treatment adherence records reported by the e-monitor box and triangulated by pill count after 6 months 2. The patient-level binary indicator of overall poor adherence (defined as = 10% of total doses missed, based on the National Tuberculosis Control Program definition of non-adherence), measured using treatment adherence records reported by the e-monitor box and triangulated by pill count after 6/7 months 3. The patient-level WHO standard definitions of TB treatment outcomes, measured using cohort management tables after 6/7 months as a percentage of all patients in the cohort, including: 3.1. Treatment completion/success, measured using cohort management tables after 6/7months 3.2. Patient loss-to-follow-up rate, measured using cohort management tables after 6/7 months 3.3. Poor treatment outcomes (defined as death, treatment failure or patient loss-to-follow-up), measured using cohort management tables after 6/7 months 3.4. Sputum conversation rate, assessed using cohort management tables after 2 months

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026