Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment modification | Experimental | Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus. |
|
| Usual care | No Intervention | Patients will receive the usual hemodialysis care with no modifications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment modification | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited, Consented, Randomized and Completed | Each participant was assessed for 6 weeks; total recruitment period was 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Burden | Number of symptoms in past week as measured by the Dialysis Symptom Index | Baseline and 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Berman, M.D. | The Rogosin Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogosin Institute | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27139523 | Result | 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. |
Not provided
Not provided
Not provided
There were 300 dialysis patients screened. 51 were eligible to participate and 16 were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Modification | Patients in this arm will be treated to different targets of blood pressure, parathyroid hormone and serum phosphorus. Treatment modification |
| FG001 | Usual Care | Patients will receive the usual hemodialysis care with no modifications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Modification | Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus |
| BG001 | Usual Care | Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Recruited, Consented, Randomized and Completed | This number represents the entire dialysis population | Posted | Count of Participants | Participants | Each participant was assessed for 6 weeks; total recruitment period was 15 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Modification | Patients were treated to modified goals in terms of blood pressure, parathyroid hormone and phosphorus |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathaniel Berman | The Rogosin Institute | 212-746-9766 | nab2009@nyp.org |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Symptom Burden | Number of symptoms in past week as measured by the Dialysis Symptom Index | Posted | Mean | Standard Deviation | symptoms | Baseline and 6 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Usual Care | Patients were treated to traditional goals in terms of blood pressure, parathyroid hormone and phosphorus | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |