End Stage Renal Disease Requiring Hemodialysis, Hemodialysis
Conditions
Keywords
Adherences, Chronic kidney disease, ESRD, Behavioral intervention
Brief 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.
Interventions
BEHAVIORALPharmacist 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).
Sponsors
Thuraya Safaa Ibrahim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End Stage Renal Disease Adherence Questionnaire (ESRD-AQ) scores | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphate | At the start of the study, and after one month of the start of the study. | Serum Phosphate levels measurement |
| Interdialytic weight gain (IDWG) | At the start of the study, and after one month of the start of the study. | Interdialytic weight gain (IDWG) Assessment |
| Total serum Calcium | At the start of the study, and after one month of the start of the study. | Total serum Calcium measurement |
| Hemoglobin levels | At the start of the study, and after one month of the start of the study. | Measurement of patients Hemoglobin levels |
Countries
Iraq
Outcome results
None listed