Nurse-led Intervention to Improve Phosphate Binder Adherence (MedAM)
A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.
Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. The control arm received standard of care.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Antwerpen, Belgien
- Dialysis hospital unit 1
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Antwerpen, Belgien
- Dialysis hospital unit 3
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Turnhout, Belgien
- Dialysis hospital unit 2
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- adult (≥18)
- chronic hemodialysis ≥1 month
- treated with phosphate binders
- Dutch-speaking
Exclusion Criteria:
- receiving professional medication care
- cognitive impairment
- nursing home residents
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Kontrolarm
Standard pleje
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Eksperimentel: Adherence support
One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills) + One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions |
One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills) + One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Medication adherence
Tidsramme: One year
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The intake of medication (phosphate binders) was monitored continuously for one year through electronic monitoring with the Medication Event Monitoring System (MEMS). Medication containers are filled with patients' phosphate binders and then capped with MEMS-caps registering the time and date of each opening and thus presumed intake of the medication in the box. Mean adherence was calculated as the proportion of prescribed doses taken, averaged per month (e.g. patients with a ter in die regimen (84 doses/month) and taking them all 84 would have a mean adherence of 84/84=100%). Nonadherence was defined as a mean adherence <80%. |
One year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Serum phosphate
Tidsramme: Monthly for one year
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Serum phosphate was gathered monthly from patients' charts.
In addition to mean serum phosphate per month we dichtomised this outcome measure with >5mg/dL representing uncontrolled phosphatemia.
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Monthly for one year
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Patient knowledge
Tidsramme: At study start and end (after one year)
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Knowledge was measured by ten multiple-choice questions about the phosphate cycle, phosphate binder pharmacodynamics and dietary recommendations, developed in previous research and added as appendix in a previous article (Van Camp Y, Vrijens B, Abraham I, et al.
Adherence to phosphate binders in hemodialysis patients: prevalence and determinants.
J Nephrol 2013; JNEPHROL-D-13-00176R1: Publicatin in process)
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At study start and end (after one year)
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Social support
Tidsramme: At study start and end (after one year)
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Social support was measured by eleven questions assessing perceived support in general and support with taking phosphate binders specifically, developed in previous research and added as appendix in a previous article (Van Camp Y, Vrijens B, Abraham I, et al.
Adherence to phosphate binders in hemodialysis patients: prevalence and determinants.
J Nephrol 2013; JNEPHROL-D-13-00176R1: publication in process)
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At study start and end (after one year)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yoleen PM Van Camp, MScN, Universiteit Antwerpen
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UA-B300201111744
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