Determining the effect of nurse-led medication care program on medication adherence and symptom burden in patients undergoing hemodialysis.
Design
A randomized controlled trial with a control group on 62 patients, non-blind with parallel-group
Settings and conduct
The study will involve 62 hemodialysis patients at Shayan Hemodialysis Center and Shahid Rahimi Hospital in Khorramabad who will be randomly assigned to intervention and control groups. The intervention group will be received training in pharmacologic care in patients with chronic renal failure.
Participants/Inclusion and exclusion criteria
Inclusion
1.Having chronic renal failure
2.Having at least two comorbid disease including hypertension, diabetes
3. Hemodialysis three times a week for at least three months
4. Orientation to time, location and person and having stable hemodynamic status.
5. Absence of any disabling hearing, vision, or speech impairment
6. Having stable physical and mental conditions
7. Being literate
Exclusion criteria
1. Participation in other similar training and empowerment programs in the field of medication care
2. Hemodialysis patients younger than 18 years and older than 60 years .
Intervention groups
After visit by nephrologist and clinical pharmacist, the participants in the intervention group will receives by researcher nurse, 30 minute training each week for eight sessions, in accordance with the educational booklet titled “Medication care in patients with chronic Kidney disease.
The control group will receives routine training.
Main outcome variables
Medication adherence and symptom burden in patients undergoing hemodialysis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250514065726N2
Registration date:2026-05-02, 1405/02/12
Registration timing:prospective
Last update:2026-05-02, 1405/02/12
Update count:0
Registration date
2026-05-02, 1405/02/12
Registrant information
Name
Shourangiz Beiranvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0140
Email address
shourangiz.beiranvand@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2026-12-22, 1405/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nurse-led medication care program on medication adherence and symptom burden in patients undergoing hemodialysis.
Public title
The effect of medication care program on medication adherence and symptom burden in dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic renal failure
Having at least two comorbid disease including hypertension, diabetes
Hemodialysis three times a week for at least three months
Orientation to time, location and person and having stable hemodynamic status.
Absence of any disabling hearing, vision, or speech impairment
Having stable physical and mental conditions
Being literate
Exclusion criteria:
Participation in other similar training and empowerment programs in the field of medication care
Hemodialysis patients younger than 18 years and older than 60 years .
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
62 eligible dialysis patients will be conveniently recruited into the study. It using a four-block randomization method to assign patients to two group. After obtaining written informed consent from the participants, 6 different combinations of four-block (AABB- ABAB- ABBA- BBAA- BABA- BAAB) were created. It randomly selected using the Blockrand package of R software, and the random sequence will be formed as a sequence of letters A and B.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Shahid Anoushirvan Rezaei Square, Moalem St., Khorramabad, Lorestan, Iran University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2025-11-11, 1404/08/20
Ethics committee reference number
IR.LUMS.REC.1404.327
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Medication adherence
Timepoint
The questionnaire will be completed before, one and two months after the educational intervention
Method of measurement
Morisky Medication Adherence Questionnaire (MMAS)
2
Description
Symptom burden in patients undergoing hemodialysis
Timepoint
The questionnaire will be completed before, one and two months after the educational intervention
Method of measurement
Edmonton Symptom Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Medication care program was focused on the interdisciplinary care (nurse, nephrologist, and pharmacist). Patients in the intervention group receive a monthly visit from a nephrologist who prescribes routine medications and laboratory tests. A clinical pharmacist also visits patients monthly to monitor adherence, identify any errors in dosage, timing, or route of administration, detect adverse drug reactions, and drug interactions. The nurse conducted individualized 30 minute training each week for eight sessions, in accordance with the educational booklet titled “Medication care in Patients with Chronic Kidney Disease. The total intervention time was two months.
Category
Lifestyle
2
Description
Control group: The control group received routine training
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shayan Hemodialysis Center, Khorramabad and Shahid Seyyed Fakhroddin Rahimi Hospital , Khorramabad