Impact of Mobile Health Interactive Software on Tuberculosis Outcomes; The Call for Life (CFLU-TB) Project

NCT04709159 | Unknown

• 1 other identifier: ST/263/2020
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 3

Brief Summary

This study will be an open-label Randomized Controlled Trial (RCT) to determine the effect of Call for Life TB (CFLU-TB) on Tuberculosis (TB) treatment success in patients with non-drug resistant Tuberculosis receiving care at three public health facilities, Kisenyi Health Centre IV, Kasangati Health Centre IV and Kiryandongo government Hospital. Call for Life TB will employ a mobile health Health technology called CONNECT FOR LIFE™ to provide SMS or Interactive Voice Response patient support. This support will be in the form of clinic appointment, daily pill reminders, reminders, health tips and an opportunity to report symptoms which are responded to by a call from study doctors. Collectively, 274 patients will be randomized (1:1ratio) to Intervention Arm (daily adherence calls, a pre-appointment reminder call, health tips and 24hr symptom reporting) or Standard of care (standard practice according to the national guidelines for TB treatment). Call for Life TB will also provide for Treatment supporters of patients on the Intervention Arm to be co-registered onto the system so as to enhance Directly Observed Treatment (DOTS). Participants will be followed up for 6 months and observational data collected at several points. Data on sociodemographics, treatment response/outcome determined at 2 and at the end of treatment. Investigators shall conduct Focus Group Discussions (FGDs) and In- Depth Interviews (IDIs) with patients and clinic staff respectively, on ease of use, acceptability and satisfaction with the intervention. Investigators will use system data to assess uptake and adherence to the tool. Investigators shall determine differences in the proportions of patients with treatment success in the two arms. Additionally, investigators shall assess adherence to medication, TB cure rates and treatment completion. Investigators shall qualitatively determine, perception, acceptability, and satisfaction with CFLU-TB. As a measure of cost-effectiveness, investigators shall determine marginal cost effectiveness CFLU-TB with regard to treatment success. The proposed study endpoint is 6-months retention in care, treatment and appointment adherence.

Conditions

Tuberculosis

Keywords

mHealth; Tuberculosis; TB

Outcome Measures

Primary Outcomes (1)

• Treatment success

  Percentage of patients with treatment success. Treatment success is the sum of the percentages of patients declared cured and those who complete treatment.

  After 6 months of treatment

Secondary Outcomes (10)

• TB cure for patients with bacteriologically diagnosed TB

  After 6 months of treatment

• Treatment completion for patients with clinically diagnosed TB

  After 6 months of treatment

• Retention in care

  At 2 and 6 months

• Experiences of patients and care providers towards CFLU™

  At baseline, 2 months and 6 months

• Cost effectiveness of the CFLU™ intervention

  At 6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants on this arm will use Interactive Voice Response (IVR) daily pill reminders, thrice-weekly health messages, clinic appointment reminders, remote symptom reporting service and a 24 hour toll-free number to access services. These participants will also have the option to co-register a caregiver who will also receive daily pill reminders, clinic appointment reminder, weekly health tips and remote symptom reporting service. In addition, these participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines.

Other: Call for Life Uganda

Standard

NO INTERVENTION

These participants will receive the standard of care according to Uganda National Tuberculosis Treatment guidelines.

Interventions

Call for Life Uganda OTHER

Call for Life™ Uganda (C4LU) is a web-based mHealth tool that provides treatment support to patients in the form of daily or weekly pill adherence reminders, health messages, clinic appointment reminders and a remote symptom reporting service. The tool interacts with patients by text message (SMS) or using voice and tone input via keypad (Interactive Voice Response - IVR) on both analogue and smart phones. The tool uses CONNECT FOR LIFE technology, which is on an open source platform developed by Grameen Foundation and the University of Southern Maine with financial support from the Bill and Melinda Gates Foundation. It was supported by Janssen, the Pharmaceutical Companies of Johnson and Johnson and was released under the terms of the MOTECH open source license agreement.

Also known as: CONNECT FOR LIFE

Intervention

Eligibility Criteria

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

You may qualify if:

• Evidence of TB diagnosis-either confirmed bacteriologically by Xpert MTB/RIF Version G4 assay (Cepheid, Sunnyvale, CA, USA) or clinically diagnosed by health worker.
• Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study.
• Willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Aged 18 years or more
• Mobile phone ownership
• Patients who can understand Luganda, Runyankole, Swahili or English. These languages are the languages spoken by of the majority of patients at three health. Other languages may be added to the service if the anticipated demand surpasses 30 patients.

You may not qualify if:

• Patient unable to use a basic feature phone or who whose clinical condition that interferes with appropriate use of cell phone for voice calls (e.g., deafness, severe cognitive impairment)
• Ongoing participation in another interventional study that the investigator believes will interfere with study procedures or assessment of outcomes of this study.
• Patients who are critically ill.
• Patients with drug resistant TB (Rifampicin resistant, Multi-drug resistant and Extensive drug resistant TB).
• Patients with TB Meningitis or Osteoarticular TB.
• Any other clinical condition that, in the opinion of the site investigator, would make the participant unsuitable for the study or unable to meet with dosing requirements.

Sponsors & Collaborators

• Makerere University: lead

Study Sites (3)

Kasangati Health Centre IV

Kampala, Uganda

RECRUITING

Kisenyi Health Centre IV

Kampala, Uganda

RECRUITING

Kiryandongo Hospital

Kiryandongo, Uganda

RECRUITING

Related Publications (1)

• Byonanebye DM, Mackline H, Sekaggya-Wiltshire C, Kiragga AN, Lamorde M, Oseku E, King R, Parkes-Ratanshi R. Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial. Trials. 2021 Jun 13;22(1):391. doi: 10.1186/s13063-021-05352-z.

  PMID: 34120649 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

CD56 Antigen

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Neural Cell Adhesion Molecules; Cell Adhesion Molecules, Neuronal; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Study Officials

• Dathan Byonanebye Mirembe, MBChB, M.MED

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dathan M Byonanebye, MBChB,M.MED

CONTACT

+256777913313; byonanebyemd@gmail.com

Rosalind P Ratanshi, MMBS,PhDFRCP

CONTACT

+256752323253; rp549@medschl.cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with two arms. Interventional Arm will receive the intervention (daily pill reminders, health messages, clinic appointment reminders, remote symptom reporting service, toll-free number to call in to receive services, plus the option to co-register a caregiver who will receive the same services as the patient) as well as standard of care. The Control arm will have patients who will receive only standard of care available at the TB clinics as per the Uganda National Tuberculosis Treatment guidelines.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: October 19, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (3)