A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- End Stage Renal Failure on Dialysis
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 135
- Locations
- 3
- Primary Endpoint
- Medication adherence
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Yoleen Van Camp
Dra.
Universiteit Antwerpen
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
Outcomes
Primary Outcomes
Medication adherence
Time Frame: 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 Outcomes
- 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))