Impact of a Pharmacist-led Patient-centred Care Intervention Along With Text-Message Reminders, on the Management of Newly Diagnosed Tubercular Patients: a Protocol for a Randomized Controlled Trial'.

NCT04645836 | Completed DMC

• 1 other identifier: FUKhan
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to standardize the management of "Pharmaceutical care with the two-way text messages and incentive for mobile usage during the treatment for tuberculosis patients, to improve the outcomes and compliance, reduce the risk of transmission and to evaluate the patient perspective in terms of their quality of life, shared decision making and satisfaction with services provided.

Conditions

Pulmonary TB; TB

Outcome Measures

Primary Outcomes (2)

• TB treatment success rates

  TB treatment success rates defined by the World Health Organization. The investigators will compare clinically reported treatment outcomes between the intervention and control groups.

  6-9 Months

• Adherence to treatment among drug-sensitive tuberculosis patients self reported and clinical record will checked for the follow up visits and drug taken

  Adherence Assessed daily from date of randomization until the date of a documented treatment outcome, up to 24 months after study enrollment date.Counting the number of administered pills, adequate adherence is more than 80% of administered pills.The measure adherence in TB patients for these determinations, we will measure patients' adherence via combined adherence endpoint consisting of Morisky Medication Adherence Scale and pill count rate.

  6-9 Months

Secondary Outcomes (3)

• Health related Quality of Life of TB patients

  6-9 Months

• Lost To Follow

  6-9 Months

• Patient satisfaction questionnaire

  6-9 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

New management mode intervention: Pharmaceutical care A more recent strategy is pharmaceutical care, where a hospital provides timely patient education, monitoring and management of adverse drug reactions, identifying other drug-related problems, and an evaluation of treatment adherence by a clinical pharmacist. At the first visit, the clinical pharmacist provides a mobile phone number and encourages patients to contact them anytime if they need any consultation on the TB treatment. Short Message Service and Phone calls daily use of the mobile phone for a TB treatment will support pharmaceutical care. TB patients or family members will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.

Behavioral: New management mode

No Intervention Group.

NO INTERVENTION

Treatment Group included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by World Health Organization and routine treatment group (6 months treatment regimen); Routine health education provided by health care professionals.

Interventions

New management mode BEHAVIORAL

New management mode intervention: Pharmaceutical care * SMS text messages and Phone Calls * Behavioural Educational leaflet * Self-Administered Therapy A financial incentive for mobile use

Also known as: Pharmaceutical care, Mobile text, Financial incentive for mobile use

Intervention Group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Newly bacteriologically confirmed TB case (less than a month since diagnosis). This restriction (not more than one-month treatment) does not refer to patients whose most recent treatment outcome was a failure and who were assigned to a new treatment regimen.
• Own a mobile phone which operates on a telecom provider supported by our SMS platform
• Know how to and are able to receive SMS messages or Phone Call (Caretaker want to participate in case original patient do not participate)
• An address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.
• No plans to move out of the catchment areas of the participating TB program sites within 9 months of enrollment.
• Facilities must have at least one TB doctor and one TB nurse available within the facility.
• Willingness to comply with study procedures and provide written informed consent prior to study enrollment.

You may not qualify if:

• Diagnosis is extra-pulmonary TB
• Currently enrolled in a clinical trial that prohibits enrollment in another study. Patients are leaving the area within the next six months.
• Patients are known at the start of treatment to require the treatment longer than it is recommended TB Management Guidelines for the appropriate type of TB.
• Previous history of TB, multidrug-resistant (MDR) or extensively drug-resistant (XDR) TB.
• Very ill patient's cognitive or physical disability that prevents full participation in the study such as vision, hearing, physically challenged, inability to swallow medications and unconscious Unable to answer questions.
• Pregnant females (treatment of TB infection will be deferred)
• Patients who are receiving treatment from private clinics (Who are not registered in the government TB sectors and they seek are form private health care facilities.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead
• Pakistan Institute of Medical Sciences: collaborator
• Quaid i Azam University Islamabad Pakistan: collaborator

Study Sites (1)

Pakistan Institute of Medical Sciences Islamabad

Islamabad, 46000, Pakistan

Location

Related Publications (1)

• Khan FU, Khan FU, Hayat K, Fang Y. Impact of a pharmacist-led patient-centred care intervention along with textmessage reminders, on the management of newly diagnosed tubercular patients: A protocol for a randomized controlled trial. Pak J Med Sci. 2024 Jan-Feb;40(3Part-II):487-491. doi: 10.12669/pjms.40.3.5356.

  PMID: 38356837 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yu Fang, Phd

  Xi'an Jiaotong University

  STUDY CHAIR

• Amjad Khan, Phd

  Quaid i Azam University Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Phd Scholar)

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: November 27, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

PA (1)