Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03395366 |
| Other study ID # |
AAAR6257 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
April 28, 2020 |
Study information
| Verified date |
March 2022 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately
400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and
emotional toll on patients, and most patients on hemodialysis describe poor quality of life.
Patients on hemodialysis have worse health related quality of life (HrQOL) than patients with
any other chronic illness including cancer and congestive heart failure. This poor quality of
life can affect how well these patients manage their own health or their self-care, and can
ultimately lead to poor health outcomes. Despite this, there are no commonly used programs to
improve quality of life or self-care for patients on hemodialysis. The investigators have
developed a simple 3-step program to improve quality of life and self-care for patients on
hemodialysis. The first step involves presenting quality of life scores to the dialysis
health care team so that a program can be designed. The second step involves 8-12 education
sessions combined with behavioral training designed to improve quality of life and self-care.
The final step is monthly re-evaluation of progress. In this study, the investigators will
test this 3-step program, compared to dialysis education alone, to see if it improves quality
of life and self-care. By improving quality of life and self-care the investigators believe
patient outcomes including hospitalizations will improve.
Description:
Hemodialysis (HD) patients have worse health related quality of life (HrQOL) than patients
with any other chronic illness. In this population, poor quality of life and depressive
symptoms (a major component of HrQOL) are associated with medication non-compliance, dietary
indiscretion, interdialytic weight gain, and missed dialysis. These associations likely
explain the link between low HrQOL scores and adverse medical outcomes. Even small decrements
in HrQOL score are associated with an increased risk of hospitalizations and mortality.
Moreover, depressive symptoms occur in one-third of HD patients and are themselves associated
with increased hospitalizations and with a 1.5 times higher mortality risk.
To address poor HrQOL in HD patients, the Centers for Medicare Services (CMS) mandated its
screening on a regular basis in all HD patients. However, CMS has not mandated how to present
HrQOL results to key HD providers, or how to treat those with poor HrQOL. Nor are there
widely applied methods of doing so. Although prior interventions in HD patients have improved
quality of life and self-management, these interventions were limited by poor patient and
physician adoption, a lack of reproducible methods, selective inclusion and exclusion
criteria and a lack of translatability. To date there are no widely adopted interventions to
improve quality of life in this population. Thus, it is not surprising that, HrQOL scores
remain unchanged in 8 years since the CMS mandate. In sum, HrQOL survey results have not been
applied in a manner that makes a difference for patients.
Cognitive behavioral therapy (CBT) is a structured psychotherapy intervention designed to
address and treat dysfunctional cognitions, negative emotions and maladaptive behaviors. In
patients with chronic illness, CBT has been adapted to successfully improve adherence to
self-management behaviors. In patients with ESRD, several studies have used cognitive
behavioral strategies to improve self-management, quality of life, and depressive symptoms.
These studies however were limited by high drop-out rates and a lack of translatability. To
date, cognitive behavioral (CB) strategies are not routinely used in the care of ESRD
patients.
The investigators have developed a simple, translatable 3-step intervention to improve poor
HrQOL in hemodialysis patients. The first step is a one-page dashboard that presents
actionable HrQOL data to key stakeholders (social workers, nutritionists, primary nurses,
nurse-practioners, physicians, patients and family members) during monthly case conference.
The second step is a treatment approach that combines self-management education with CB
strategies through 8-12 simple sessions delivered chair-side over 12 weeks. These sessions
are designed to be delivered by unit social workers and are highly translatable to other US
hemodialysis units. The final step is monthly re-evaluation at clinical case conference where
patient progress will be assessed and the dashboard and behavioral-education sessions
refined. Each step of the intervention was designed to be highly translatable to current
hemodialysis care. The dashboard utilizes data that is currently checked, the treatment
sessions are delivered by social workers that are already employed at hemodialysis centers
and re-evaluation occurs during monthly case conference sessions that are already being held.
The investigators hypothesize that implementing their multi-faceted intervention will improve
HrQOL, depressive symptoms and self-management, and will be immediately translatable to other
US hemodialysis units. Therefore, the investigators propose to conduct a 16-week randomized
controlled trial in 40 subjects on hemodialysis with poor HrQOL to test the impact of the
intervention on these outcomes. The primary outcome, Kidney Disease Quality of Life Short
Form 36 (KDQOL-36™) survey scores, will be measured at 0, 8, and 16 weeks. Through
end-of-study focus groups, the investigators will refine the intervention and help translate
our intervention into practice. Additionally, the investigators will develop a translatable
toolbox that will give step-by-step instructions on how to implement our intervention at
other US hemodialysis units. Finally, the investigators will explore the effect of our
intervention on hospitalizations.
