Condition category
Infections and Infestations
Date applied
28/05/2011
Date assigned
21/07/2011
Last edited
16/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Tuberculosis (TB) is a bacterial infection that mainly affects the lungs. China has the second largest number of TB cases in the world, next only to India. New technology such as medication monitoring and mobile phone text messaging may provide a good opportunity for improving the treatment of TB . The aim of this study to find out whether mobile text messaging and medication monitoring can improve adherence to TB medication and the outcomes of TB treatment.

Who can participate?
Newly registered TB patients aged 18 and over from 36 districts/counties in four provinces (Chongqing, Hubei, Jiangsu and Heilongjiang) in China.

What does the study involve?
The 36 districts/counties are randomly allocated to one of four groups. In the first group patients are provided with mobile phones. On medication intake days patients are sent a short message service (SMS) to remind them to take their medication. They respond with a brief message when they have taken their medication. Doctors in the TB dispensary collect the SMS feedback from patients to assess how many doses are missed in a month. Based on the number of missed doses, there will be additional visits from the township/village doctor. In the second group patients are provided with a medication monitor box with reminding functions. This tool is used to remind patients to take their tuberculosis medication and also records drug intake. Doctors at the TB dispensary collect the drug intake record from the medication monitor monthly to assess how many doses are missed in a month. Based on the number of missed doses, there will be additional visits from the township/village doctor. In the third group patients are provided with both the mobile phone and the medication monitor box to remind them to take their medication and to record drug intake. The drug intake record from the medication monitor and SMS from patients are collected monthly, and the number of doses missed in a month is calculated using the drug intake record of the medication monitor. Based on the number of missed doses, there will be additional visits from the township/village doctor. In the fourth group patients are managed based on the current standard of care.

What are the possible benefits and risks of participating?
There are no major risks in taking part in the study.

Where is the study run from?
36 districts/counties in four provinces (Chongqing, Hubei, Jiangsu and Heilongjiang) in China.

When is the study starting and how long is it expected to run for?
June 2011 to August 2012.

Who is funding the study?
The Bill and Melinda Gates Foundation (USA).

Who is the main contact?
Shiwen Jiang
jiangsw@chinatb.org

Trial website

Contact information

Type

Scientific

Primary contact

Prof Shiwen Jiang

ORCID ID

Contact details

China Center for Disease Control and Prevention
No. 155 Changbai Road
Changping District
Beijing
102206
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

51914

Study information

Scientific title

Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management

Acronym

Study hypothesis

Innovative approaches for enhancing TB patient treatment management such as mobile text messaging and medication monitor can improve adherence to TB medication and outcomes of TB treatment

Ethics approval

1. Ethical Review Committee of China CDC. 12/07/2010, ref: 201008
2. London School of Hygiene and Topical Medicine Ethics Committee, 23/06/2010, ref: 5704

Study design

Cluster randomized non-blinded controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis

Intervention

This is a cluster randomised non blinded trial. Clusters are defined as a county or district. This is a four armed trial, three intervention arms and one control arm:
1. Mobile phone
Patients are provided with mobile phones as a reminding tool to take their tuberculosis medication. On medication intake days patients are sent a SMS to remind them to take their medication. They respond with a brief message when medication is taken. Doctors in TB dispensary collect the SMS feedback from patients to assess how many doses are missed in a month. Based on the missed doses, additional intervention and incentive mechanisms are implemented such as visits from the township/village doctor and incentives per visit given to the township/village doctor.
2. Medication monitor
Patients are provided with a medication monitor box with reminding functions. This tool is used to remind patients to their tuberculosis medication and also records drug intake. Doctors at the TB dispensary collect the drug intake record from medication monitor monthly to assess that how many doses are missed in a month. Based on the missed doses, additional intervention and incentive mechanism are implemented as described in the mobile phone intervention (1)
3. Mobile phone and medication monitor
Patients are provided with both the mobile phone and medication monitor box with reminding function for as tools for communication, reminding and recording drug intake. The drugs intake record from medication monitor and SMS from patients are collected monthly, and the number of doses missed in a month is calculated using the drug intake record of the medication monitor. Based on the missed doses, additional intervention and incentive mechanism are implemented as described in the mobile phone intervention (1)
4. Control
Patients are managed based on the current standard of care.

All patients will be followed up to the end of tuberculosis treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The mean proportion of months a patient has at least 3 doses missed (this is based on pill count data from the medication monitor box)

Secondary outcome measures

1. The mean proportion of months a patient has at least 7 doses missed
2. The mean proportion of overall missed doses
3. Proportion of patients defined as non-adherent (at least 10% of doses missed)
4. Proportion of patients defaulting during TB treatment
5. Proportion of smear positive TB cases who become smear negative at 2 months
6. The proportion of patients with treatment outcome of cure or completed treatment

Overall trial start date

01/06/2011

Overall trial end date

31/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. TB patients, smear-positive or smear-negative, recruited from the study clusters (county/district)
2. Willing to participate in the study
3. Conscious without any mental disease
4. Conscious without any visual, auditory or language impairment
5. At least 18 years old
6. Patient or family member is able to read a short message service (SMS)/ text and use medication monitor after training

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4176 (116 per cluster; 9 clusters per arm; 4 arms)

Participant exclusion criteria

1. Does not meet inclusion criteria
2. Patients with tuberculosis pleurisy
3. Patients with no sputum smear data at tuberculosis diagnosis

Recruitment start date

01/06/2011

Recruitment end date

31/08/2012

Locations

Countries of recruitment

China

Trial participating centre

China Center for Disease Control and Prevention
Beijing
102206
China

Sponsor information

Organisation

China Center for Disease Control and Prevention (China)

Sponsor details

No. 155 Changbai Road
Changping District
Beijing
102206
China

Sponsor type

Government

Website

http://www.chinatb.org/

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (Grant ref: 51914)

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26372470

Publication citations

Additional files

Editorial Notes