NCT07067528Toborzás még nem indult
The Feasibility and Acceptability of a Post-tuberculosis Lung Disease Diagnostic Algorithm in Uganda.
The Feasibility and Acceptability of a Diagnostic Algorithm for Timely Post-tuberculosis Lung Disease Diagnosis at Primary Health Care Facilities in Mbarara, Uganda.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 16. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
The goal of this clinical trial is to determine whether a structured diagnostic algorithm improves the identification and referral of people with post-tuberculosis lung disease (PTLD) in primary healthcare facilities in Uganda. The clinical trial will, in addition, assess how feasible and acceptable it is for health workers to use this algorithm as part of routine care. The main trial questions are: * Does the diagnostic algorithm increase identification and referral of patients with suspected PTLD compared to standard care? * Is the algorithm feasible to implement and acceptable to health providers and patients in real-world primary health care settings? The research team will compare four health centre level III (HCIII) facilities ( two using the diagnostic algorithm and two using standard care) to see if the algorithm helps with early diagnosis and referral of PTLD. Health centre level III in Uganda are the primary health facilities and have provision for tuberculosis treatment. Participants will be screened for PTLD at the time they complete tuberculosis treatment at their local health facility. At intervention sites, participants will undergo assessment using a structured PTLD diagnostic algorithm developed in earlier stages of this research. The algorithm will be based on a symptom questionnaire and clinical criteria. At control sites, participants will be evaluated using standard practices (consensus clinical definition only). Participants clinically suspected to have PTLD. will be referred to Mbarara Regional Referral Hospital. Primary care health facilities will: * Be randomly assigned to use either the diagnostic algorithm or standard care. * Receive a baseline training on PTLD and ongoing support through monthly video conference * Submit triplicate referral forms to track referrals.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 80 (tervezett)
- Első benyújtás
- 2025. júl. 3.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2029. aug. 31.
- Fő szponzor
- Mbarara University of Science and Technology
- Betegségek
- Tuberkulózis
- NCT-szám
- NCT07067528
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 80
- 2026. szept. 1. és az elsődleges befejezés (2029. aug. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- It was previously included in a similar PTLD-related intervention trial.
- A patient will be excluded if:
- They have a previously confirmed diagnosis of an unrelated chronic respiratory condition (e.g., pulmonary malignancy, cystic fibrosis).
- They were already referred or diagnosed with PTLD prior to this screening.
Egyéb
- A facility will be excluded if:
- It declines to participate or cannot commit to consistent follow-up activities.
- It lacks the minimum staff or infrastructure to carry out screening and referral procedures.
- They did complete treatment for pulmonary TB or lack documentation of cure.
Kiket keres a vizsgálat
- A health facility must meet all of the following criteria to participate in the study.
- Located within a 10 km radius of Mbarara Regional Referral Hospital (MRRH).
- Has an operational TB clinic with at least one designated TB clinician or nurse.
- Facility in-charge (or designated representative) provides written informed consent for participation.
- Willing to implement the PTLD screening procedures and participate in biweekly follow-up communications.
- Agrees to assign a contact staff member to coordinate trial-related activities.
- Patients screened at participating facilities must meet all of the following:
- Aged ≥18 years.
- Completed microbiologically confirmed treatment for pulmonary tuberculosis (TB).
- Presenting with persistent or new respiratory symptoms following TB treatment completion.
- Able and willing to provide written informed consent
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Mbarara University of Science and Technology/Mbarara Regional Referral Hospital | Mbarara | Uganda | Ismeretlen állapot |
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