- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03395366
Improving Outcomes for Hemodialysis Patients
Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- DaVita Columbia University Dialysis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients on hemodialysis for at least 3 months
- Most recent 36-question Kidney Disease Quality of Life (KDQOL-36), Physical Component Summary (PCS), or Mental Component Summary (MCS) score below 50
- KDQOL-36 burden of disease score 80
- Expected survival 6 months
- English-speaking
Exclusion Criteria:
- Bipolar or Psychotic disorder
- Moderate or severe cognitive impairment as determined by the hemodialysis staff or documented in the electronic medical record (EMR)
- Severe vision or hearing impairment
- Drug or alcohol dependence
- Active suicidal ideation or a history of suicide attempt (determined based on screening patient health questionnaire-9 and EMR)
- Current participation in a behavioral or education treatment program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Multifaceted Educational / Cognitive Behavioral Intervention
|
The intervention includes 8 to 12 one-on-one sessions over a 12-week period, run by a licensed social worker (LSW) with experience delivering therapy.
Curriculum will introduce education relevant for self-management and consists of prepared slides, handouts & worksheets.
The education was designed based on slides developed and published online by the national kidney foundation and the national kidney disease education program.
The curriculum was designed to be understandable by all potential subjects, including those with low literacy levels.
Sessions will incorporate behavior-based activities designed to deliver education about and improve upon medication adherence, diet, exercise, and coping.
These activities, based around CB strategies such as cognitive restructuring and behavior shaping, will include review of self-management logs, goal setting, creation of treatment plan, problem-solving techniques, reinforcing techniques, and coping with ESRD.
|
No Intervention: Group 2
Standard of Care + Dialysis Education without the Cognitive Behavioral component
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™)
Time Frame: 0 weeks, 8 weeks, 16 weeks
|
The investigators will summarize the average changes from pre to post for each treatment arm via means (±SD) and 95% confidence intervals and estimate the effect of our intervention by estimating a linear model for each post-treatment score, adjusting for pre-treatment score and treatment arm (i.e. an ANCOVA model).
|
0 weeks, 8 weeks, 16 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shayan Shirazian, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR6257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on Multifaceted Educational / Cognitive Behavioral Intervention
-
University of TorontoCanadian Institutes of Health Research (CIHR)Completed
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedAdverse Drug ReactionBrazil
-
Philipps University Marburg Medical CenterAstraZenecaUnknownDepression | Chronic Obstructive Pulmonary Disease | End-of-Life Fear | Fear About Death and DyingGermany
-
VA Office of Research and DevelopmentCompletedAtrial Fibrillation | Venous Thromboembolism | AnticoagulantsUnited States
-
Norwegian University of Science and TechnologyNorwegian Nurses OrganisationCompleted
-
Aveiro UniversityFundação para a Ciência e a TecnologiaCompleted
-
University of Rochester NCORP Research BaseNational Cancer Institute (NCI)CompletedInsomnia | Cancer Survivor | Malignant NeoplasmUnited States
-
VA Office of Research and DevelopmentActive, not recruitingTraumatic Brain Injury | Cognitive SymptomsUnited States
-
Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH)CompletedAttention Deficit Hyperactivity DisorderUnited States
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan