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
1 other identifier
interventional
135
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 10, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedFebruary 14, 2014
February 1, 2014
1 year
February 10, 2014
February 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Serum phosphate
Monthly for one year
Patient knowledge
At study start and end (after one year)
Social support
At study start and end (after one year)
Study Arms (2)
Adherence support
EXPERIMENTALOne-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
Control arm
NO INTERVENTIONStandard care
Interventions
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
Eligibility Criteria
You may qualify if:
- adult (≥18)
- chronic hemodialysis ≥1 month
- treated with phosphate binders
- Dutch-speaking
You may not qualify if:
- receiving professional medication care
- cognitive impairment
- nursing home residents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Dialysis hospital unit 1
Antwerp, Belgium
Dialysis hospital unit 3
Antwerp, Belgium
Dialysis hospital unit 2
Turnhout, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Yoleen PM Van Camp, MScN
Universiteit Antwerpen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dra.
Study Record Dates
First Submitted
February 10, 2014
First Posted
February 14, 2014
Study Start
November 1, 2011
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
February 14, 2014
Record last verified: 2014-02