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

NCT01549457 | Unknown Early Phase 1

• 1 other identifier: H11-02216
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Latent Tuberculosis Infection

Keywords

latent tuberculosis; text message interventions; medication adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  4 or 9 months

Study Arms (2)

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.

Other: Cell phone text messages

Interventions

Cell phone text messages OTHER

Participants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are.

Cell phone intervention arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• British Columbia Cancer Agency: collaborator

Study Sites (3)

New Westminster TB Control Clinic

New Westminster, British Columbia, Canada

Location

Vancouver Downtown TB Control Clinic

Vancouver, British Columbia, Canada

Location

Vancouver TB Control Clinic (VTC),

Vancouver, British Columbia, Canada

Location

Related Publications (3)

• 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.

  PMID: 34702229 DERIVED

• Johnston 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.

  PMID: 29437940 DERIVED

• van 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.

  PMID: 24719431 DERIVED

MeSH Terms

Conditions

Latent Tuberculosis; Medication Adherence

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dr. Richard Lester, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

CA (3)