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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'.

24. juni 2022 oppdatert av: Farman Ullah Khan, Health Science Center of Xi'an Jiaotong University
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Tuberculosis (TB) remains a top ten leading cause of death globally despite it being a largely curable disease. New effective treatment supervision strategies are needed particularly in low-resource high TB burden settings and a potential solution is in the hands of nearly every patient - a mobile phone. Modern modular design mobile phone software applications ("apps") hold great promise to address this unmet need. Current technologies allow for rapid design modification based on end-user needs, implementation of native operating system (e.g., Android) versions for users with inconsistent internet access, and the integration of the patients' experiences with electronic health records using industry standards. Apps can perform multiple functions (e.g., automated reminders, symptom tracking, secure messaging, and multi-media education). Another strategy is pharmaceutical care which is utilized to enhance TB treatment compliance along with usage of mobile technologies, where clinical pharmacists provide patient education to improve the patient's knowledge on the disease and medication use and address the patient's drug-related problems. The use of a pharmaceutical care model to improve treatment outcomes and enhance adherence is on the rise in healthcare organizations. 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. Patients will make prior arrangements with a study pharmacist to determine a convenient meeting place. These meetings will continue until treatment completion. To our knowledge, worldwide there has only been no randomized controlled trial (RCT) which has described the use of both pharmaceutical care model and two-way Short Message Service (SMS) communication with financial incentives (mobile money transfer cover healthcare costs related to SMS charges) to improve treatment outcomes. To find out both the pharmaceutical care model and two-way SMS communication with financial incentives would be helpful for TB patients in Pakistan. Therefore investigator aimed a study, to find out the effectiveness of trial gauged with the impact of the suggested model on the improved adherence, treatment completion, health-related quality of life and satisfaction with TB care.

Studietype

Intervensjonell

Registrering (Faktiske)

450

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Islamabad, Pakistan, 46000
        • Pakistan Institute of Medical Sciences Islamabad

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 78 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervensjonsgruppe

Ny administrasjonsmodusintervensjon: Farmasøytisk omsorg En nyere strategi er farmasøytisk omsorg, der et sykehus gir rettidig pasientopplæring, overvåking og håndtering av bivirkninger, identifiserer andre legemiddelrelaterte problemer og en evaluering av behandlingsoverholdelse av en klinisk farmasøyt. Ved det første besøket oppgir den kliniske farmasøyten et mobilnummer og oppfordrer pasienter til å kontakte dem når som helst hvis de trenger konsultasjon om tuberkulosebehandlingen.

Kortmeldingstjeneste og telefonsamtaler daglig bruk av mobiltelefonen til TB-behandling vil støtte farmasøytisk behandling. TB-pasienter eller familiemedlemmer vil motta telefoner hver kveld (unntatt søndag) under hele den ambulante TB-behandlingsfasen for å sikre at pasienten tar medisinene som er foreskrevet og gitt av TB-legen, og for å samle informasjon om behandlingsoverholdelse og mulige bivirkninger.

New management mode intervention: Pharmaceutical care

  • SMS text messages and Phone Calls
  • Behavioural Educational leaflet
  • Self-Administered Therapy A financial incentive for mobile use
Andre navn:
  • Farmasøytisk omsorg, Mobiltekst, Økonomisk insentiv for mobilbruk
Ingen inngripen: Ingen intervensjonsgruppe.
Behandlingsgruppen inkludert i kontrollarmen vil motta tradisjonell - klinisk direkte observert terapi (DOT) som anbefalt av Verdens helseorganisasjon og rutinebehandlingsgruppen (6 måneders behandlingsregime); Rutinemessig helseundervisning gitt av helsepersonell.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
TB treatment success rates
Tidsramme: 6-9 Months
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
Tidsramme: 6-9 Months
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health related Quality of Life of TB patients
Tidsramme: 6-9 Months
At baseline and upon completion of the treatment. To measure HRQoL (Health related Quality of Life) Revalidated data assortment tool European Quality of Life Scale EQ 5D 3L
6-9 Months
Lost To Follow
Tidsramme: 6-9 Months
Lost to follow up or Treatment defaulters patients will be recorded from TB registers upon completion of the treatment
6-9 Months
Patient satisfaction questionnaire
Tidsramme: 6-9 Months
At baseline and upon completion of the treatment. Satisfaction with information can be assessed with the satisfaction with information about medicines scale along with the Beliefs about medicines questionnaire.
6-9 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Yu Fang, Phd, Health Science Center of Xi'an Jiaotong University
  • Studieleder: Amjad Khan, Phd, Quaid i Azam University Islamabad

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2020

Primær fullføring (Faktiske)

30. desember 2021

Studiet fullført (Faktiske)

30. desember 2021

Datoer for studieregistrering

Først innsendt

15. november 2020

Først innsendt som oppfylte QC-kriteriene

19. november 2020

Først lagt ut (Faktiske)

27. november 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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