End Stage Renal Failure on Dialysis
Conditions
Keywords
Adherence, dialysis, intervention, nurse-led, phosphate binders, trial
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.
Interventions
BEHAVIORALAdherence 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
Sponsors
Universiteit Antwerpen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | One year | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum phosphate | Monthly for one year | 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 | At study start and end (after one year) | 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 | At study start and end (after one year) | 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) |
Countries
Belgium
Outcome results
None listed