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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Steuerarm
Standardpflege
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Experimental: 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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Medication adherence
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Serum phosphate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Yoleen PM Van Camp, MScN, Universiteit Antwerpen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UA-B300201111744
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