NCT Number: NCT02063490
The study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Dialysis hospital unit 1, Antwerp, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Nurse-led multifactorial intervention, Individualised management
Time frame: One year
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%.
Time frame: Monthly for one year
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.
Time frame: At study start and end (after one year)
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)
Time frame: At study start and end (after one year)
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)
Universiteit Antwerpen
Other
A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Acronym: MedAM
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