Plain English Summary
Background and study aims
The majority of dialysis patients are using phosphate binders to prevent or reduce high phosphate blod levels. In this study we want to investigate adherence to, knowledge and beliefs about phosphate binder treatment in dialysis patients. We also want to investigate whether counselling about phosphate binder treatment changes these parameters and the phosphate blod levels.
Who can participate?
Dialysis patients aged 18 years or more, attending the Dialysis centre at Akershus unitversitetssykehus, can participate in the study.
What does the study involve?
All participants in the study will receive a one-to.one pharmacist-led education and counselling session. All participants will answer three questionnaires twice. These include questions about phosphate binders, adherence to phosphate binder treatment and beliefs about phosphate binder treatment.
What are the possible benefits and risks of participating?
The study is assumed to be of potential benefit for the participants by improving their knowledge about phosphate binders and their awareness of the importance of phosphate binder treatment.
There are no risks of participating in the study. Participation includes counselling by a pharmacist about phosphate binder treatment. Participants need to spend a bit of time answering questionnaires, during dialysis.
Where is the study run from?
The study is a cooperation between the Hospital pharmacy and the Dialysis centre at Akershus unversitetssykehus.
When is the study starting and how long is it expected to run for?
The study started in May 2017 and the approximate duration of the trial was two months.
Who is funding the study?
The Hospital Pharmacies Enterprise, South Eastern Norway are paying the costs that the trial will incur.
Who is the main contact?
If you have any questions regarding the study, please contact Bodil Jahren Hjemas, bodil.jahren.hjemas@sykehusapotekene.no
Trial website
Contact information
Type
Public
Primary contact
Mrs Bodil Jahren Hjemås
ORCID ID
http://orcid.org/0000-0002-6956-2859
Contact details
Sykehusapoteket Ahus
Postboks 35
Lørenskog
1478
Norway
+4767960302
bodil.jahren.hjemas@sykehusapotekene.no
Type
Scientific
Additional contact
Mrs Kathrin Bjerknes
ORCID ID
Contact details
Sykehusapoteket Ahus
Postboks 35
Lørenskog
1478
Norway
+4740638644
Kathrin.Bjerknes@sykehusapotekene.no
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2016/1996/REK sør-øst
Study information
Scientific title
Interventional study to improve adherence to phosphate binder treatment in dialysis patients
Acronym
Study hypothesis
A one-to-one pharmacist-led education and counselling can enhance adherence and lead to changes in serum phosphate in dialysis patients.
Ethics approval
Approved 20/12/2016, The Regional Committee for Medical and Health Research Ethics, REK sør-øst (Postboks 1130, Blindern, 0318 Oslo; +47 22 84 55 11; rek-sorost@medisin.uio.no ), ref: 2016/1996
Study design
A descriptive interventional single-centre single arm pre-post study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Kidney disease requiring dialysis
Intervention
Patients included in the study received a single half-hour one-to-one pharmacist-led education and personalized counselling session. A semi-structured counselling guide was used in the session. An educational leaflet based on this guide was offered to the included patients.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Change in the proportion of patients with serum phosphate below 1.80 mmol/L. Serum phosphate levels for five months prior to the intervention, and five months after were drawn from the medical records for included patients.
Secondary outcome measures
Change in the patient's knowledge, beliefs and adherence after the intervention measured by completion of questionnaires:
'Patient Knowledge'
'Medication Adherence Report Scale'
'Beliefs about Medicines Questionnaire'
The participants were asked to answer the questionnaires twice; at the time of inclusion and 3 - 4 weeks after the intervention.
Overall trial start date
20/01/2016
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age>18 years
2. Receiving chronic dialysis two to four times a week for at least five months
3. Using at least one self-administered phosphate binder
4. Able to speak, read and write Norwegian
5. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
At study start 122 patients attended the hospital dialysis centre.
Total final enrolment
69
Participant exclusion criteria
1. Life expectancy < 5 months
Recruitment start date
22/05/2017
Recruitment end date
27/06/2017
Locations
Countries of recruitment
Norway
Trial participating centre
Akershus universitetssykehus HF Akershus University Hospital
Postboks 1000
Lørenskog
1478
Norway
Sponsor information
Organisation
The Hospital Pharmacies Enterprise, Sout Eastern Norway
Sponsor details
Stenersgate 1
PB. 79
Oslo
0050
Norway
+4723135200
post@sykehusapotekene.no
Sponsor type
Other
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Hospital Pharmacies Enterprise
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We wish to submit a manuscript for publication in BMC Nephrology in spring 2019, including the main results from the study.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
15/04/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://pubmed.ncbi.nlm.nih.gov/31101020/ (added 02/09/2020)