- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01621997
Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.
Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.
During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Beijing
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Beijing, Beijing, Kina, 100034
- Jie Dong
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- CAPD patients.
- Medically stable and receiving PD for<1 week
- age between 18 and 80 years
- self-care or doing bag exchange by a fixed assistant Exclusion Criteria
- followed up at least every 2 months
- dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China
Exclusion Criteria:
- Pregnancy;
- undergoing APD therapy
- Intolerance to the study protocols;
- Severe and unstable condition, acute or chronic inflammation disease;
- a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
- suffering peritonitis before receiving the interventions
- cognitive or psychological dysfunction;
- communication barrier
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: operation inspection
During retraining the patients performed bag exchange under the supervision of a nurse.
The nurse ensured that each error listed in the NAC form should be avoided, thus immediately corrected any wrong steps if only.
|
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
Eksperimentel: verbal education
Patients in the oral education group also underwent retraining every 2 months.
A nurse would address all items in the NAC form one by one, to remind the patient of the key points of bag exchange.
Scores calculated by the sum of error items during the bag exchange for patients in technique inspection group, or by the sum of "yes" in the interactive quiz for patients in verbal education group.
|
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
Eksperimentel: usual care
Patients in the usual care group did not receive any retraining
|
Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months. Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
first-episode peritonitis
Tidsramme: 48 months
|
Infection rates were calculated as the number of infections divided by the total time at risk, and expressed as episodes per 100 patient-years at risk.
|
48 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
first-episode enteric peritonitis,first-episode non-enteric peritonitis
Tidsramme: 48 moths
|
Enteric organisms included enterococcus and enterobacter.
|
48 moths
|
transition transition to haemodialysis, and all-cause death.
Tidsramme: 48 moths
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transition to haemodialysis, and all-cause death.
|
48 moths
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jie Dong, MD,PhD,, Peking University First Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PD TRAINING
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