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Nurse-led Intervention to Improve Phosphate Binder Adherence (MedAM)

Primary Purpose

End Stage Renal Failure on Dialysis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Adherence support
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Failure on Dialysis focused on measuring Adherence, dialysis, intervention, nurse-led, phosphate binders, trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dialysis hospital unit 1
  • Dialysis hospital unit 3
  • Dialysis hospital unit 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adherence support

Control arm

Arm Description

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

Standard care

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.
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)
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)

Full Information

First Posted
February 10, 2014
Last Updated
February 12, 2014
Sponsor
Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT02063490
Brief Title
Nurse-led Intervention to Improve Phosphate Binder Adherence
Acronym
MedAM
Official Title
A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis
Keywords
Adherence, dialysis, intervention, nurse-led, phosphate binders, trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adherence support
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Adherence support
Other Intervention Name(s)
Nurse-led multifactorial intervention, Individualised management
Intervention Description
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
Primary Outcome Measure Information:
Title
Medication adherence
Description
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
One year
Secondary Outcome Measure Information:
Title
Serum phosphate
Description
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
Monthly for one year
Title
Patient knowledge
Description
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)
Title
Social support
Description
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)
Time Frame
At study start and end (after one year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoleen PM Van Camp, MScN
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dialysis hospital unit 1
City
Antwerpen
Country
Belgium
Facility Name
Dialysis hospital unit 3
City
Antwerpen
Country
Belgium
Facility Name
Dialysis hospital unit 2
City
Turnhout
Country
Belgium

12. IPD Sharing Statement

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Nurse-led Intervention to Improve Phosphate Binder Adherence

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