Adherence to, knowledge and beliefs about drugs used to reduce phosphate absorption in dialysis patients
| ISRCTN | ISRCTN52852596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52852596 |
| Secondary identifying numbers | 2016/1996/REK sør-øst |
- Submission date
- 10/04/2019
- Registration date
- 11/04/2019
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Public
Sykehusapoteket Ahus
Postboks 35
Lørenskog
1478
Norway
 ORCID ID |
0000-0002-6956-2859 |
|---|---|
| Phone | +4767960302 |
| bodil.jahren.hjemas@sykehusapotekene.no |
Scientific
Sykehusapoteket Ahus
Postboks 35
Lørenskog
1478
Norway
| Phone | +4740638644 |
|---|---|
| Kathrin.Bjerknes@sykehusapotekene.no |
Study information
| Study design | A descriptive interventional single-centre single arm pre-post study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Interventional study to improve adherence to phosphate binder treatment in dialysis patients |
| Study objectives | A one-to-one pharmacist-led education and counselling can enhance adherence and lead to changes in serum phosphate in dialysis patients. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/01/2016 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | At study start 122 patients attended the hospital dialysis centre. |
| Total final enrolment | 69 |
| Key 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 |
| Key exclusion criteria | 1. Life expectancy < 5 months |
| Date of first enrolment | 22/05/2017 |
| Date of final enrolment | 27/06/2017 |
Locations
Countries of recruitment
- Norway
Study participating centre
Lørenskog
1478
Norway
Sponsor information
Other
Stenersgate 1
PB. 79
Oslo
0050
Norway
| Phone | +4723135200 |
|---|---|
| post@sykehusapotekene.no | |
| Website | https://sykehusapotekene.no/ |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 15/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/05/2019 | 02/09/2020 | Yes | No |
Editorial Notes
02/09/2020: Publication reference and total final enrolment number added.
12/04/2019: Internal review.
11/04/2019: Trial’s existence confirmed by The Regional Committee for Medical and Health Research Ethics, REK.
