HemodialysisNCT06744738
Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence
A study testing Pharmacist led behavioral change technique in people with Hemodialysis and End Stage Renal Disease Requiring Hemodialysis, run by Thuraya Safaa Ibrahim at 1 site in Iraq.
Trial summary
A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease Requiring Hemodialysis
- What is being tested?
- Pharmacist led behavioral change technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIraq
- Study dates
- 2 Feb 2024to 25 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion
Who cannot join
- Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.
- Being tested
- Pharmacist led behavioral change technique
- Keywords
- Adherences, Chronic kidney disease, ESRD, Behavioral intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist led behavioral change techniqueBehavioural
The intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined.
The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts.
The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid).
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | The usual care group received the usual care offered by the center to all patients, which included printed, paper-based, and verbal instructions. The written material included knowledge about diet recommendations for dialysis patients based on National Kidney Foundation recommendations. Verbal instructions were provided by the physician, including information regarding their medications, dialysis, diet, and fluid intake based on their condition and monthly lab results. Medications are provided to all patients at no cost, and pharmacists provide instructions on how to use them. |
| pharmacist-led behavioral change technique | Experimental | The intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined.
The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts.
The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid). Receives: Behavioral: Pharmacist led behavioral change technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores
The ESRD-AQ is a comprehensive tool that records critical elements of patients' treatment history: self-reported treatment adherence (including HD attendance, prescriptions, fluid restrictions, and dietary recommendations); perceptions regarding adherence behaviors; and justifications for nonadherence. ESRD-AQ consists of 46 questions, scores range from 0 to 1,200, with higher scores signify better adherence. Scores are divided into three ranges to identify adherence behavior (good adherence scores range between 1000 to 1200, moderate adherence scores range between 700 to 999, and poor adherence scores are less than 700). The scores were distributed over the four dimensions as follows: adherence to HD sessions (scores 0 - 600), adherence to dietary recommendations (scores 0 - 200), adherence to medications (scores 0 - 200), and adherence to fluid restriction (scores 0 - 200)
Measured: At the start of the study, and after one month of the start of the study.
Secondary outcomes (4)
Serum Phosphate
Serum Phosphate levels measurement
Measured: At the start of the study, and after one month of the start of the study.
Interdialytic weight gain (IDWG)
Interdialytic weight gain (IDWG) Assessment
Measured: At the start of the study, and after one month of the start of the study.
Total serum Calcium
Total serum Calcium measurement
Measured: At the start of the study, and after one month of the start of the study.
Hemoglobin levels
Measurement of patients Hemoglobin levels
Measured: At the start of the study, and after one month of the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start2 Feb 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuraya Safaa Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thuraya Safaa Ibrahim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744738
- Sponsor's protocol ID
- RECAUCP8720246
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ansaf TS, Al-Hamadani FY, Brown S, James DH. Pharmacist-led behavioral change intervention improves adherence and clinical outcomes among hemodialysis patients. Sci Rep. 2025 Sep 29;15(1):33661. doi: 10.1038/s41598-025-18082-y.
PubMed 41023004
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence
- ClinicalTrials.gov ID
- NCT06744738
- Acronym / sponsor ID
- RECAUCP8720246
- Keywords
- Adherences, Chronic kidney disease, ESRD, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Thuraya Safaa IbrahimUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from BCT. The study includes two groups: usual care and pharmacist-led intervention groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –The usual care group received the usual care offered by the center to all patients, which included printed, paper-based, and verbal instructions. The written material included knowledge about diet recommendations for dialysis patients based on National Kidney Foundation recommendations. Verbal instructions were provided by the physician, including information regarding their medications, dialysis, diet, and fluid intake based on their condition and monthly lab results. Medications are provided to all patients at no cost, and pharmacists provide instructions on how to use them. |
| pharmacist-led behavioral change technique | Experimental | Behavioral: Pharmacist led behavioral change techniqueThe intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined. The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts. The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) at the time of inclusion
Key exclusion criteria (1 listed)
- Switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist led behavioral change techniqueThe intervention was developed based on the behavior change technique taxonomy (v1). This intervention was designed to improve adherence to all therapeutic aspects of hemodialysis patients, including the dialysis program, medications, diet, and fluids. Additionally, the effect of the pharmacist intervention on physiological indices (serum potassium, total calcium, phosphate, IDWG, and hemoglobin) was examined. The program was explicitly created for implementation in an actual setting, ensuring that the time allocation for participants and facilitators (the party responsible for conducting the PL-BCT) remained reasonable in most contexts. The BCT components were developed after the identification and coding of the BCTs from previous interventional studies that contain behavioral components and result in positive effects on one or more hemodialysis patients' adherence domains toward their therapeutic regimen (dialysis program, medications, diet, and fluid). | Behavioural | pharmacist-led behavioral change technique |
Primary outcome
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores
Time frame: At the start of the study, and after one month of the start of the study.
The ESRD-AQ is a comprehensive tool that records critical elements of patients' treatment history: self-reported treatment adherence (including HD attendance, prescriptions, fluid restrictions, and dietary recommendations); perceptions regarding adherence behaviors; and justifications for nonadherence. ESRD-AQ consists of 46 questions, scores range from 0 to 1,200, with higher scores signify better adherence. Scores are divided into three ranges to identify adherence behavior (good adherence scores range between 1000 to 1200, moderate adherence scores range between 700 to 999, and poor adherence scores are less than 700). The scores were distributed over the four dimensions as follows: adherence to HD sessions (scores 0 - 600), adherence to dietary recommendations (scores 0 - 200), adherence to medications (scores 0 - 200), and adherence to fluid restriction (scores 0 - 200)
4 secondary outcomes
Serum Phosphate
Time frame: At the start of the study, and after one month of the start of the study.
Interdialytic weight gain (IDWG)
Time frame: At the start of the study, and after one month of the start of the study.
Total serum Calcium
Time frame: At the start of the study, and after one month of the start of the study.
Hemoglobin levels
Time frame: At the start of the study, and after one month of the start of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 41023004Ansaf TS, Al-Hamadani FY, Brown S, James DH. Pharmacist-led behavioral change intervention improves adherence and clinical outcomes among hemodialysis patients. Sci Rep. 2025 Sep 29;15(1):33661. doi: 10.1038/s41598-025-18082-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist led behavioral change technique in people with Hemodialysis and End Stage Renal Disease Requiring Hemodialysis, run by Thuraya Safaa Ibrahim at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores (time frame: At the start of the study, and after one month of the start of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06744738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.