Dialysis-Less Frequently In The Elderly (D-LITE)
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|ClinicalTrials.gov Identifier: NCT03787719|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dialysis End Stage Renal Disease Hemodialysis||Other: Twice per week dialysis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single center pilot study|
|Masking:||None (Open Label)|
|Official Title:||Dialysis-Less Frequently In The Elderly (D-LITE) Pilot Study|
|Actual Study Start Date :||June 27, 2018|
|Estimated Primary Completion Date :||November 11, 2020|
|Estimated Study Completion Date :||November 11, 2020|
Experimental: Twice per week dialysis
Twice-weekly 4 hour dialysis treatment (Monday and Friday or Tuesday and Saturday).
Other: Twice per week dialysis
Twice-weekly 4 hour dialysis treatment
No Intervention: Thrice per week dialysis
Standard thrice-weekly 4 hour dialysis treatment (Monday, Wednesday and Friday or Tuesday, Thursday and Staurday)
- Recruitment [ Time Frame: 1 year ]Successful recruitment will be defined as >3-4 patients/month over 12 months providing informed consent and meeting criteria for randomization.
- percent of prescribed treatments completed by patient [ Time Frame: 1 year ]Successful adherence will be defined as => 90% of intervention being adhered to.
- Loss to trial completion [ Time Frame: 1 year ]Successful loss to trial completion will be defined as = >50% of randomized patients completing the 12 month trial. Based on our data, the anticipated reasons for loss to trial completion will be death and moving away from the study center.
- Percent of weekly potassium values falling within normal range. [ Time Frame: 1 year ]Potassium will be measured every week for the duration of the study.
- Percent of weekly post hemodialysis weights that are within 1 kg of prescribed dry weight [ Time Frame: 1 year ]Prescribed and acheived post HD weight will be recorded weekly.
- Change in Patient's Quality of Life - Using Edmonton Symptom Assessment System (ESAS-R) [ Time Frame: 1 year ]
The purpose of the ESAS tool is to help with the assessment of 9 symptoms which includes: pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath and well-being.
The ESAS-R is a semantic differential scale which asks respondents to answer a questionnaire and choose between two opposite position (e.g., "No Pain" or "Worst Possible Pain", "No Tiredness" or "Worst Possible Tiredness", etc). The patient will rate the severity of each symptom from 0 to 10. The lower the value the better the outcome.
This study will measure the change in ESAS-r symptoms over time. The ESAS-r is always done on the ESAS-r numerical scale and the results later transferred to the ESAS-r Graph.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787719
|Contact: Christine White, MDfirstname.lastname@example.org|
|Contact: Andrew L Nguyen, MSc||613-533-6000 ext email@example.com|
|Kingston Health Sciences Centre (KHSC)||Recruiting|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator: Christine White, MD|
|Sub-Investigator: Hasitha Welihinda, MD|