The role of clinical pharmacists' intervention on improving the adherence to treatment and clinical outcomes among hemodialysis patients
| ISRCTN | ISRCTN75517095 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75517095 |
| Secondary identifying numbers | Grant number 232/2021 |
- Submission date
- 23/03/2022
- Registration date
- 25/03/2022
- Last edited
- 14/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Hemodialysis is a procedure where a dialysis machine and a special filter called an artificial kidney, or a dialyzer, are used to clean your blood.
Following treatment recommendations (adherence) is challenging in hemodialysis (HD) patients, yet it has been found to be extremely crucial in obtaining positive clinical and health outcomes. This study aimed to evaluate the role of clinical pharmacists in enhancing HD patients’ adherence to treatment recommendations and improving clinical outcomes.
Who can participate?
Adult (over 18 years) hemodialysis patients who have been undergoing dialysis for more than three months
What does the study involve?
Patients will receive a monthly educational session, for three months, that covers the disease and its management with recommendations for improving adherence and quality of life. An instructional booklet will be handed to participants in the intervention group as well.
What are the possible benefits and risks of participating?
This study will be beneficial to participants in improving management outcomes. No minimal risk is expected.
Where is the study run from?
Jordan University of Science and Technology
When is the study starting and how long is it expected to run for?
March 2021 to November 2021
Who is funding the study?
This work was supported by the Deanship of Scientific Research at Jordan University of Science and Technology (grant number 232/2021).
Who is the main contact?
Dr Osama Alshogran, oyalshogran@just.edu.jo
Contact information
Principal Investigator
Faculty of Pharmacy/Jordan University of Science and Technology
Irbid
22110
Jordan
 ORCID ID |
0000-0002-2466-4763 |
|---|---|
| Phone | +962 798318927 |
| oyalshogran@just.edu.jo |
Study information
| Study design | Randomized open-label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The role of clinical pharmacist in enhancing hemodialysis patients’ adherence and clinical outcomes: a randomized-controlled study |
| Study objectives | The intervention group, which received education from a clinical pharmacist, would be more committed to the recommendations, have fewer complications, and improved clinical outcomes, as compared to the control group (who received standard medical care provided by other health care providers). |
| Ethics approval(s) | Approved 26/04/2021, Institutional review board (IRB) committee at Jordan University of Science and Technology (King Abdullah University 7th Floor - Wing D., Amman - Ramtha highway Irbid Jordan; +962 2 7200600 Ext. (45102); IRB@just.edu.jo), ref: 11/140/2021 |
| Health condition(s) or problem(s) studied | Adherence to treatment in dialysis patients |
| Intervention | Using stratified sampling based on age and gender, eligible patients were randomly assigned to intervention or control groups. The intervention group will receive an educational instructional session by a clinical pharmacist that covers recommendations about the disease and its complications, medication information and adherence, common adverse drug events and how to prevent them, the value of adherence to diet and fluid restrictions, the importance of regular follow-up with the medical team and undertaking required laboratory testing, and doing exercise. The control will receive the usual care. Follow up is for 3 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Overall adherence to treatment recommendations assessed using a previously validated ESRD-AQ tool. This was assessed at baseline and after three months of follow up |
| Secondary outcome measures | 1. Quality of life measured using KDQOLTM-36 at baseline and after three months of follow up 2. Disease awareness measured using interview with clinical pharmacist at baseline and after three months of follow up 3. Number of emergency or hospital admissions measured using patient records for three months of follow up 4. Biochemical measurements included serum levels of sodium, potassium, urea, creatinine, albumin, hemoglobin level, calcium, phosphorus, and PTH which were obtained from patients' medical records at baseline and after three months of follow up |
| Overall study start date | 31/03/2021 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 114 |
| Key inclusion criteria | 1. At least 18 years old 2. Been on continuous HD for at least three months 3. Stable medical condition |
| Key exclusion criteria | 1. Mental disease 2. Malignancies 3. Acute illness 4. Terminally ill 5. Under irregular dialysis |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 01/09/2021 |
Locations
Countries of recruitment
- Jordan
Study participating centres
22110
Jordan
11937
Jordan
11941
Jordan
Sponsor information
University/education
Deanship of research
Irbid
22110
Jordan
| Phone | +962 27201000 |
|---|---|
| research@just.edu.jo | |
| Website | https://www.just.edu.jo/Deanships/DeanshipofResearch/Pages/Default.aspx# |
"ROR" |
https://ror.org/03y8mtb59 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- عمادة البحث العلمي جامعة العلوم والتكنولوجيا الأردنية
- Location
- Jordan
Results and Publications
| Intention to publish date | 01/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon reasonable request from authors oyalshogran@just.edu.jo |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 12/07/2022 | 14/07/2022 | Yes | No |
Editorial Notes
14/07/2022: Publication reference added.
25/03/2022: Trial's existence confirmed by Institutional review board (IRB) committee at Jordan University of Science and Technology
