Pharmacist-led Intervention on Hemodialysis Patients' Therapy Adherence

Thuraya Safaa Ibrahim

Status: Completed

Conditions: Hemodialysis; End Stage Renal Disease Requiring Hemodialysis

Treatments: Behavioral: Pharmacist led behavioral change technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06744738

RECAUCP8720246

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Behavioral: Pharmacist led behavioral change technique