Latent Tuberculosis InfectionEarly Phase 1NCT01549457
TB mHealth Study - Use of Cell Phones to Improve Compliance in Patients on LTBI Treatment
A Early Phase 1 study testing Cell phone text messages in people with Latent Tuberculosis Infection, run by University of British Columbia at 3 sites in Canada.
Trial summary
This study will examine the impact of use of mobile phones and text messaging on adherence to treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study participants will receive weekly text messages inquiring on their health status in relation to their prescribed treatment, while the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- Cell phone text messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2012to Oct 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are initiating treatment for latent TB infection;
- Are over the age of 18 years old;
- Own a mobile phone or share access mobile phone access with a household member who consents to participate; AND
- Demonstrate sufficient ability to communicate via text messaging in English or have a family member or friend that is able to provide translation and assistance with text messaging for the duration of the study
Who cannot join
- Individuals under the age of 18;
- Unable to adequately send and receive text messages for any reason OR
- Enrolled in another clinical trial that may assess or influence treatment adherence.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
New Westminster TB Control Clinic
New Westminster, British Columbia
Vancouver Downtown TB Control Clinic
Vancouver, British Columbia
Vancouver TB Control Clinic (VTC),
Vancouver, British Columbia
About this study
Official title: The Effect of Weekly Text-message Communication on Treatment Completion Among Patients With Latent Tuberculosis Infection: a Randomised Controlled Trial (WelTel LTBI)
This study will examine the impact of use of mobile phones and text messaging on adherence to treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study participants will receive weekly text messages inquiring on their health status in relation to their prescribed treatment, while the other half (50%) will not receive weekly text messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and by interviewing patients at each of these visits.
The investigators hypothesis is that enhanced communication with a health care provider, via a structured cell phone SMS text messaging based program (WelTel), will result in a 15% improvement in the proportion of patients who successfully complete their LTBI treatment regimens.
Read the detailed description
- Purpose The purpose of this study is to compare the proportion of patients who are adherent to their TB medications among those receiving weekly text messages plus standard of care and those who receive standard of care only.
- Justification: Previous research has shown that weekly text messages from a health care provider increases medication adherence for HIV patients. The investigators would like to determine if a similar effect in terms of adherence can be seen in patients receiving medication for latent tuberculosis infection
- Objectives
Primary Objective:
- To compare successful treatment completion rates for patients treated with 9 months of INH or 4 months of RIF between those receiving weekly SMS text messages via mobile phone plus standard of care to those receiving standard care. The standard of care at the TB clinics for all LTBI patients includes provision of a 30 day supply of medications - isoniazid 300mg daily for 9 months months or rifampin 600mg daily for 4 months - at a time, monthly blood-work and monthly clinic visits. Successful treatment completion is defined as taking at least 80% of the doses of INH prescribed within 12 months or at least 80% of the doses of RIF prescribed within 6 months.
Secondary Objectives:
- To compare the proportion of prescribed doses taken on schedule (daily adherence) prior to medication discontinuation or interruption on medical advice between those receiving weekly SMS text messages via mobile phone to those receiving standard care;
- To measure patient satisfaction with the SMS intervention using a provider administered questionnaire including a series of Likert questions.
- Research Method
This study is a prospective open-label multicentre randomized controlled trial of a clinical intervention. It is estimated that 350 study participants will be required to have 80% power to detect a 15% difference in adherence at a .05 level of significance. In addition to recruiting English-speaking participants, the investigators will also be recruiting participants that have Chinese and Punjabi as their first language.
Upon consent, participants will be randomly assigned to receive either 1) standard of care (9 months of INH or 4 months of RIF) and weekly SMS text messages via mobile phone or 2) standard of care (9 months of INH or 4 months of RIF) without weekly SMS text messages via mobile phone.
The clinicians, pharmacists and researchers involved in evaluating compliance will not be blinded to the allocation of the intervention and control groups, as they will be required to review patients charts periodically, respond to patients text messages when they are experiencing difficulty in taking medications or side effects, as well as to ensure the successful operation of the SMS technology platform.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- Cell phone text messages
- Keywords
- latent tuberculosis, text message interventions, medication adherence
- Medical subject headings
- Latent Tuberculosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell phone text messagesOther
Participants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are.
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention | No intervention | Participants will only receive standard of care |
| Cell phone intervention arm | Experimental | Upon consent, participants will be randomly assigned to receive either 1) standard of care (9 months of INH or 4 months of RIF) and weekly SMS text messages via mobile phone or 2) standard of care (9 months of INH or months of RIF) without weekly SMS text messages via mobile phone. Receives: Other: Cell phone text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of LTBI treatment regimens.
Successful treatment completion is defined as taking at least 80% of the doses of INH prescribed within 12 months or at least 80% of RIF prescribed within 6 months.
Measured: 4 or 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Responsible party
- Sponsor
- Investigators
- Dr. Richard Lester, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549457
- Sponsor's protocol ID
- H11-02216
- Status last verified
- Oct 2015
- First submitted
- 6 Mar 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
El Joueidi S, Bardosh K, Musoke R, Tilahun B, Abo Moslim M, Gourlay K, MacMullin A, Cook VJ, Murray M, Mbaraga G, Nsanzimana S, Lester R. Evaluation of the implementation process of the mobile health platform 'WelTel' in six sites in East Africa and Canada using the modified consolidated framework for implementation research (mCFIR). BMC Med Inform Decis Mak. 2021 Oct 26;21(1):293. doi: 10.1186/s12911-021-01644-1.
PubMed 34702229Johnston JC, van der Kop ML, Smillie K, Ogilvie G, Marra F, Sadatsafavi M, Romanowski K, Budd MA, Hajek J, Cook V, Lester RT. The effect of text messaging on latent tuberculosis treatment adherence: a randomised controlled trial. Eur Respir J. 2018 Feb 7;51(2):1701488. doi: 10.1183/13993003.01488-2017. Print 2018 Feb.
PubMed 29437940van der Kop ML, Memetovic J, Patel A, Marra F, Sadatsafavi M, Hajek J, Smillie K, Thabane L, Taylor D, Johnston J, Lester RT. The effect of weekly text-message communication on treatment completion among patients with latent tuberculosis infection: study protocol for a randomised controlled trial (WelTel LTBI). BMJ Open. 2014 Apr 9;4(4):e004362. doi: 10.1136/bmjopen-2013-004362.
PubMed 24719431
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weekly Text-message Communication on Treatment Completion Among Patients With Latent Tuberculosis Infection: a Randomised Controlled Trial (WelTel LTBI)
- ClinicalTrials.gov ID
- NCT01549457
- Acronym / sponsor ID
- H11-02216
- Conditions
- Latent Tuberculosis Infection
- Keywords
- latent tuberculosis, text message interventions, medication adherence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- British Columbia Cancer Agency
- Study start
- Apr 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the impact of use of mobile phones and text messaging on adherence to treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study participants will receive weekly text messages inquiring on their health status in relation to their prescribed treatment, while the other half (50%) will not receive weekly text messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and by interviewing patients at each of these visits.
The investigators hypothesis is that enhanced communication with a health care provider, via a structured cell phone SMS text messaging based program (WelTel), will result in a 15% improvement in the proportion of patients who successfully complete their LTBI treatment regimens.
Detailed description
- Purpose The purpose of this study is to compare the proportion of patients who are adherent to their TB medications among those receiving weekly text messages plus standard of care and those who receive standard of care only.
- Justification: Previous research has shown that weekly text messages from a health care provider increases medication adherence for HIV patients. The investigators would like to determine if a similar effect in terms of adherence can be seen in patients receiving medication for latent tuberculosis infection
- Objectives
Primary Objective:
- To compare successful treatment completion rates for patients treated with 9 months of INH or 4 months of RIF between those receiving weekly SMS text messages via mobile phone plus standard of care to those receiving standard care. The standard of care at the TB clinics for all LTBI patients includes provision of a 30 day supply of medications - isoniazid 300mg daily for 9 months months or rifampin 600mg daily for 4 months - at a time, monthly blood-work and monthly clinic visits. Successful treatment completion is defined as taking at least 80% of the doses of INH prescribed within 12 months or at least 80% of the doses of RIF prescribed within 6 months.
Secondary Objectives:
- To compare the proportion of prescribed doses taken on schedule (daily adherence) prior to medication discontinuation or interruption on medical advice between those receiving weekly SMS text messages via mobile phone to those receiving standard care;
- To measure patient satisfaction with the SMS intervention using a provider administered questionnaire including a series of Likert questions.
- Research Method
This study is a prospective open-label multicentre randomized controlled trial of a clinical intervention. It is estimated that 350 study participants will be required to have 80% power to detect a 15% difference in adherence at a .05 level of significance. In addition to recruiting English-speaking participants, the investigators will also be recruiting participants that have Chinese and Punjabi as their first language.
Upon consent, participants will be randomly assigned to receive either 1) standard of care (9 months of INH or 4 months of RIF) and weekly SMS text messages via mobile phone or 2) standard of care (9 months of INH or 4 months of RIF) without weekly SMS text messages via mobile phone.
The clinicians, pharmacists and researchers involved in evaluating compliance will not be blinded to the allocation of the intervention and control groups, as they will be required to review patients charts periodically, respond to patients text messages when they are experiencing difficulty in taking medications or side effects, as well as to ensure the successful operation of the SMS technology platform.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intervention | No intervention | –Participants will only receive standard of care |
| Cell phone intervention arm | Experimental | Other: Cell phone text messagesUpon consent, participants will be randomly assigned to receive either 1) standard of care (9 months of INH or 4 months of RIF) and weekly SMS text messages via mobile phone or 2) standard of care (9 months of INH or months of RIF) without weekly SMS text messages via mobile phone. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are initiating treatment for latent TB infection;
- Are over the age of 18 years old;
- Own a mobile phone or share access mobile phone access with a household member who consents to participate; AND
- Demonstrate sufficient ability to communicate via text messaging in English or have a family member or friend that is able to provide translation and assistance with text messaging for the duration of the study
Key exclusion criteria (3 listed)
- Individuals under the age of 18;
- Unable to adequately send and receive text messages for any reason OR
- Enrolled in another clinical trial that may assess or influence treatment adherence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell phone text messagesParticipants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are. | Other | Cell phone intervention arm |
Primary outcome
Successful completion of LTBI treatment regimens.
Time frame: 4 or 9 months
Successful treatment completion is defined as taking at least 80% of the doses of INH prescribed within 12 months or at least 80% of RIF prescribed within 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 34702229El Joueidi S, Bardosh K, Musoke R, Tilahun B, Abo Moslim M, Gourlay K, MacMullin A, Cook VJ, Murray M, Mbaraga G, Nsanzimana S, Lester R. Evaluation of the implementation process of the mobile health platform 'WelTel' in six sites in East Africa and Canada using the modified consolidated framework for implementation research (mCFIR). BMC Med Inform Decis Mak. 2021 Oct 26;21(1):293. doi: 10.1186/s12911-021-01644-1.
- Derived from this study: PubMed 29437940Johnston JC, van der Kop ML, Smillie K, Ogilvie G, Marra F, Sadatsafavi M, Romanowski K, Budd MA, Hajek J, Cook V, Lester RT. The effect of text messaging on latent tuberculosis treatment adherence: a randomised controlled trial. Eur Respir J. 2018 Feb 7;51(2):1701488. doi: 10.1183/13993003.01488-2017. Print 2018 Feb.
- Derived from this study: PubMed 24719431van der Kop ML, Memetovic J, Patel A, Marra F, Sadatsafavi M, Hajek J, Smillie K, Thabane L, Taylor D, Johnston J, Lester RT. The effect of weekly text-message communication on treatment completion among patients with latent tuberculosis infection: study protocol for a randomised controlled trial (WelTel LTBI). BMJ Open. 2014 Apr 9;4(4):e004362. doi: 10.1136/bmjopen-2013-004362.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Richard Lester, MD principal investigator
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cell phone text messages in people with Latent Tuberculosis Infection, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of LTBI treatment regimens. (time frame: 4 or 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01549457, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.