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

Universiteit Antwerpen

Status: Completed

Conditions: End Stage Renal Failure on Dialysis

Treatments: Behavioral: Adherence support

Study type: Interventional

Funder types: Other

Identifiers

NCT02063490

UA-B300201111744

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Adherence support

Experimental group

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

Treatment:

Behavioral: Adherence support

Control arm

No Intervention group

Description:

Standard care