Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

NCT ID: NCT06744738

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodialysis End Stage Renal Disease Requiring Hemodialysis

Keywords

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Adherences Chronic kidney disease ESRD Behavioral intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

pharmacist-led behavioral change technique

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).

Group Type EXPERIMENTAL

Pharmacist led behavioral change technique

Intervention Type BEHAVIORAL

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).

Interventions

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Pharmacist led behavioral change technique

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thuraya Safaa Ibrahim

OTHER

Sponsor Role lead

Responsible Party

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Thuraya Safaa Ibrahim

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Baghdad Medical City

Baghdad, , Iraq

Site Status

Countries

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Iraq

References

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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.

Reference Type DERIVED
PMID: 41023004 (View on PubMed)

Other Identifiers

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RECAUCP8720246

Identifier Type: -

Identifier Source: org_study_id