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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02063490
Other study ID # UA-B300201111744
Secondary ID
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


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
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