Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis

NCT03582592 | Completed

• 1 other identifier: USTCON-2016-SR39
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fluid restriction is necessary among patients with chronic kidney disease. However, treatment adherence remains a challenge. Hence, this study determined the effects of a fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing hemodialysis. This study used a single-blind, randomized-controlled pilot study design. Patients with end-stage renal disease were randomly-assigned using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the fluid distribution timetable or standard care. Adherence to fluid restriction was measured using two indicators - thirst and interdialytic weight gain - and were compared using One-way RM-MANOVA and MANCOVA. Secondary outcomes included baseline patient demographic and clinical characteristics and were compared according to treatment allocation. Both groups were followed-up for four weeks, assessing outcome measures during the second hemodialysis session for each week.

Conditions

End-Stage Kidney Disease; Hemolysis; Nursing

Keywords

Fluid distribution timetable; Fluid restriction adherence; End-Stage Kidney Disease; Hemodialysis; Thirst; Interdialytic Weight Gain; Nursing

Outcome Measures

Primary Outcomes (2)

• Perceived Thirst

  The Dialysis Thirst Inventory (DTI) measured perceived thirst among the participants. It is a 7-item questionnaire answered on 5-point Likert scale, with scores ranging from 7 to 35 and higher scores indicating higher thirst. No cut-off score is present for the questionnaire; however, higher scores are interpreted as higher perceived thirst.

  4 Weeks

• Interdialytic Weight Gain

  It is the net increase in body weight from previous post-dialysis weight measured in kilograms

  4 Weeks

Secondary Outcomes (8)

• Age

  Week 1

• Sex

  Week 1

• Educational Attainment

  Week 1

• Blood Pressure

  4 Weeks

• Pulse Rate

  4 Weeks

Study Arms (2)

Fluid Distribution Timetable (FDT) Group

EXPERIMENTAL

It is the fluid distribution timetable. It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.

Behavioral: Fluid Distribution Timetable

Comparison Group

NO INTERVENTION

It is the standard of care that served as the intervention. The control group received the standard care for patients on hemodialysis. The standard care involves a 10 -15-minute face-to-face health teaching of their treatment regimen including pharmacologic management, dialysis schedule, dietary and fluid restrictions or nutritional therapy, care for vascular access, and other necessary lifestyle modifications.

Interventions

Fluid Distribution Timetable BEHAVIORAL

It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.

Fluid Distribution Timetable (FDT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were diagnosed with end stage renal disease (ESRD);
• were oligoanuric (oliguria of \<1mL/kg/hour or anuria over 6 hours);
• had been on hemodialysis for at least 6 months;
• were alert and oriented; and,
• were scheduled for hemodialysis twice a week

You may not qualify if:

• Patients who were pregnant;
• had a history of or has overt mental illness;
• were lethargic, disoriented, or debilitated during recruitment; and,
• had complicated medical conditions such as congestive heart failure and pulmonary congestion

Sponsors & Collaborators

• University of Santo Tomas Hospital, Philippines: lead

Related Publications (1)

• Mina RJL, Lerma MB, Litan PLB, Milano AAL, Mojica ADR, Malong-Consolacion CP, Lerma EB, Macindo JRB, Torres GCS. Fluid distribution timetable on adherence to fluid restriction of patients with end-stage renal disease undergoing haemodialysis: Single-blind, Randomized-Controlled Pilot Study. J Adv Nurs. 2019 Jun;75(6):1328-1337. doi: 10.1111/jan.13964. Epub 2019 Mar 18.

  PMID: 30706521 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hemolysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rame John L Mina, BSN, RN

  UST College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student Nurse

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 11, 2018
• Study Start: September 15, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share