Condition category
Urological and Genital Diseases
Date applied
10/04/2019
Date assigned
11/04/2019
Last edited
12/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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.

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

https://sykehusapotekene.no/

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

Publication citations

Additional files

Editorial Notes

12/04/2019: Internal review. 11/04/2019: Trial’s existence confirmed by The Regional Committee for Medical and Health Research Ethics, REK.