TB mHealth Study - Use of Cell Phones to Improve Compliance in Patients on LTBI Treatment

October 7, 2015 updated by: University of British Columbia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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

  3. Objectives

Primary Objective:

1) 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:

  1. 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;
  2. To measure patient satisfaction with the SMS intervention using a provider administered questionnaire including a series of Likert questions.

4) 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 Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
        • New Westminster TB Control Clinic
      • Vancouver, British Columbia, Canada
        • Vancouver Downtown TB Control Clinic
      • Vancouver, British Columbia, Canada
        • Vancouver TB Control Clinic (VTC),

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Are initiating treatment for latent TB infection;
  2. Are over the age of 18 years old;
  3. Own a mobile phone or share access mobile phone access with a household member who consents to participate; AND
  4. 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

Exclusion Criteria:

  1. Individuals under the age of 18;
  2. Unable to adequately send and receive text messages for any reason OR
  3. Enrolled in another clinical trial that may assess or influence treatment adherence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-intervention
Participants will only receive standard of care
Experimental: Cell phone intervention arm
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.
Other: Cell phone text messages
Participants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 or 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

British Columbia Cancer Agency

Investigators

  • Principal Investigator: Dr. Richard Lester, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 9, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H11-02216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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