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Table 3 Summary of ongoing randomised controlled trials of eHealth interventions for TB

From: Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial

Study number1

Yr2

End date

Country

I/C3

Sample size

Study population

Intervention-eHealth for adherence

Control

Primary outcome

Other relevant outcomes

1

2017

2017

Kenya

I

1200

Any age; clinically diagnosed with TB by smear microscopy, culture or GeneXpert; has access to mobile phone

Daily request for self-verification of drug intake; Messages via ‘Keheala’ using text message-like interactions

Patients receive medication for 1–2 w; assigned a friend or family member supporter to verify the patient’s drug intake and return to the clinic with patient for refills

Unsuccessful treatment outcomes

–

2

2014

2017

Moldova

I

400

18+ y; at least 4 m of care remaining; not homeless, in prison, alcoholic/drug users, on injectables

VOT – daily observation of drug intake observed via internet video messages; VOT observers view and respond to video messages sent by patients

DOT – patient goes to polyclinic to be observed taking treatment every day

Adherence to medication

Adherence 80%; treatment success (measured at 4 months); side effects reported during treatment

3

2014

20154

Armenia

C

380

18+ y; diagnosed with drug-sensitive TB and completed intensive phase

Daily SMS reminders to TB patients

DOT – observed taking treatment 6 days/w by healthcare provider

TB treatment success (cured/completed treatment) according to WHO definitions

TB treatment adherence by self-report

4

2013

20144

Cameroon

I

260

18+ y; smear positive pulmonary TB, have a mobile phone and able to receive and open SMS

Daily SMS reminders to take TB drugs; content of messages changes every 2 weeks

Patients attend appointments for drug supplies weekly/monthly in intensive phase and monthly for continuation phase; SMS sent at start and at end of treatment

Treatment cure (smear-negative) at 6 m

Treatment adherence measured by VAS and appointments attended at 2, 5, and 6 m; treatment failure at 5 m; number of patients who develop resistance at 5 and 6 m

5

2014

2016

United Kingdom

I

400

16+ y; any TB patient from participating clinics who is eligible for DOT

VOT clips submitted using a dedicated smartphone with a pre-loaded app; VOT clips read by a study nurse/VOT observer daily during weekdays, weekend clips read on Mondays

DOT – by clinic staff, community-based (responsible professional: hostel worker/pharmacist) or by outreach worker; every day or weekdays and self-administered at weekend

Proportion of participants having more than 80% of scheduled VOT/DOT sessions successfully completed in the 2 m following randomisation

Proportion of doses observed over 2 and 6 m; culture conversion at 2 m; treatment outcome at 12 m acquisition of new resistance; and membership of a transmission cluster

6

2016

2019

China

C

3000

18+ y; Xpert positive (RIF sensitive), on fixed dose combination

Patients are provided with MERM box with reminding functions (audio and light) for (i) daily drug-intake and (ii) attendance of monthly follow-up appointments

Standard of care – self-administered, family- or healthcare worker-supported; MERM in silent mode

Composite unfavourable outcome: death, loss to follow-up, treatment failure, treatment between the end of treatment and 18 m after enrolment

End of treatment outcomes; adherence outcomes

  1. 1Additional details of each study: (1) Trial registration at NCT03135366; intervention also includes access to a supporter via a chat client, and information about TB. (2) Trial registration at NCT02331732. (3) Trial registration at NCT02082340; Trial protocol: Khachadourian et al. [18]. Intervention also includes the following: (i) education and counselling session for drug-sensitive TB patients and their family members (90 min); (ii) self-administered drug intake supervised by trained family member; (iii) daily phone calls to supporting family member; (iv) patients receive weekly SMS messages to attend the clinic weekly to receive their medication; Cluster randomised – cluster is defined as a TB outpatient centre; 52 clusters in total. (4) Trial registration at PACTR201307000583416; Trial protocol: Bediang [19]. (5) Trial registration at ISRCTN26184967. (6) Trial registration at ISRCTN35812455. Intervention also includes the doctor downloading the monthly drug intake recorded from MERM and assessing how many doses have been missed, with patient. Based on the missed doses, additional interventions are recommended to be implemented by the patient’s doctor such as additional visits from the township/village doctor; Cluster randomised – cluster is defined as a county/district; 24 clusters in total
  2. 2Year trial was registered
  3. 3I/C individually (I) or cluster randomised (C)
  4. 4As reported in the trial registration
  5. DOT directly observed treatment, m month, MERM medication event reminder monitor, RIF rifampicin, SMS short message service, TB tuberculosis, VOT video-observed treatment, VAS visual analogue scale, w week, y years
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ISSN: 1745-6215