Treatment Modification to Reduce Symptom Burden in Hemodialysis
Treatment Modification and Symptom Burden in High-Risk Dialysis Patients
1 other identifier
interventional
16
1 country
1
Brief Summary
Many patients on hemodialysis experience high rates of symptom burden, such as pain, depression, anxiety and difficulty breathing. This study seeks to reduce these symptoms by modifying the usual guidelines used to manage patients on hemodialysis. For example, rather than trying to keep serum phosphorus below 5.5, patients enrolled in this study may have treatment goals of less than 6.5, in order to reduce the number of pills they need to take and potentially reduce harmful side effects. Blood pressure and serum parathyroid hormone goals will also be modified, to see if these modifications help hemodialysis patients feel better.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 9, 2018
CompletedOctober 9, 2018
September 1, 2018
1.7 years
January 16, 2013
September 25, 2018
September 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Recruited, Consented, Randomized and Completed
Each participant was assessed for 6 weeks; total recruitment period was 15 months
Secondary Outcomes (1)
Symptom Burden
Baseline and 6 weeks
Study Arms (2)
Treatment modification
EXPERIMENTALPatients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus.
Usual care
NO INTERVENTIONPatients will receive the usual hemodialysis care with no modifications
Interventions
Eligibility Criteria
You may qualify if:
- hemodialysis patient
- transplant ineligible
You may not qualify if:
- dementia
- unable to answer questionnaires for any reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Rogosin Institutelead
- Weill Medical College of Cornell Universitycollaborator
Study Sites (1)
The Rogosin Institute
New York, New York, 10021, United States
Related Publications (1)
Berman N, Reid MC, Teresi J, Eimicke JP, Adelman R. More with Less: A Trial of Reduced-Intensity Treatment in Transplant-Ineligible Hemodialysis Patients. J Palliat Med. 2016 May;19(5):503-8. doi: 10.1089/jpm.2015.0338.
PMID: 27139523RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nathaniel Berman
- Organization
- The Rogosin Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel Berman, M.D.
The Rogosin Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 25, 2013
Study Start
January 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 9, 2018
Results First Posted
October 9, 2018
Record last verified: 2018-09