Nurse-led Intervention to Improve Phosphate Binder Adherence

End Stage Renal Failure on Dialysis Clinical Trial

— MedAM  

Official title:

A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063490
• Other study ID #: UA-B300201111744
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 12, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End Stage Renal Failure on Dialysis
• Kidney Failure, Chronic

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Belgium	Dialysis hospital unit 1	Antwerpen
Belgium	Dialysis hospital unit 3	Antwerpen
Belgium	Dialysis hospital unit 2	Turnhout

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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	No
Secondary	Serum phosphate	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.	Monthly for one year	No
Secondary	Patient knowledge	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)	At study start and end (after one year)	No
Secondary	Social support	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)	At study start and end (after one year)	No