Quality of LifeNCT03395366
Improving Outcomes for Hemodialysis Patients
A study testing Multifaceted Educational / Cognitive Behavioral Intervention in people with Quality of Life and End Stage Renal Disease, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, End Stage Renal Disease
- What is being tested?
- Multifaceted Educational / Cognitive Behavioral Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Columbia University Dialysis
New York, New York, 10032
About this study
Official title: Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies
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.
Read the 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.
- Conditions
- Quality of Life, End Stage Renal Disease
- Being tested
- Multifaceted Educational / Cognitive Behavioral Intervention
- Keywords
- Hemodialysis, End Stage Renal Disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted Educational / Cognitive Behavioral InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Multifaceted Educational / Cognitive Behavioral Intervention Receives: Other: Multifaceted Educational / Cognitive Behavioral Intervention |
| Group 2 | No intervention | Standard of Care + Dialysis Education without the Cognitive Behavioral component |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™)
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).
Measured: 0 weeks, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start1 May 2018
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be designed as a 16-week randomized controlled trial in which 40 subjects on hemodialysis with below average HrQOL will be assigned to one of two educational interventions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Satellite Healthcare
- Responsible party
- Principal investigator, Shayan Shirazian, Columbia University
- Investigators
- Shayan Shirazian, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395366
- Sponsor's protocol ID
- AAAR6257
- Status last verified
- Mar 2022
- First submitted
- 4 Jan 2018
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shirazian S, Smaldone AM, Jacobson AM, Fazzari MJ, Weinger K. Improving quality of life and self-care for patients on hemodialysis using cognitive behavioral strategies: A randomized controlled pilot trial. PLoS One. 2023 May 4;18(5):e0285156. doi: 10.1371/journal.pone.0285156. eCollection 2023.
PubMed 37141225
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies
- ClinicalTrials.gov ID
- NCT03395366
- Acronym / sponsor ID
- AAAR6257
- Conditions
- Quality of Life, End Stage Renal Disease
- Keywords
- Hemodialysis, End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Satellite Healthcare
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be designed as a 16-week randomized controlled trial in which 40 subjects on hemodialysis with below average HrQOL will be assigned to one of two educational interventions.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Multifaceted Educational / Cognitive Behavioral InterventionMultifaceted Educational / Cognitive Behavioral Intervention |
| Group 2 | No intervention | –Standard of Care + Dialysis Education without the Cognitive Behavioral component |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted Educational / Cognitive Behavioral InterventionThe 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. | Other | Group 1 |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Derived from this study: PubMed 37141225Shirazian S, Smaldone AM, Jacobson AM, Fazzari MJ, Weinger K. Improving quality of life and self-care for patients on hemodialysis using cognitive behavioral strategies: A randomized controlled pilot trial. PLoS One. 2023 May 4;18(5):e0285156. doi: 10.1371/journal.pone.0285156. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shayan Shirazian, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted Educational / Cognitive Behavioral Intervention in people with Quality of Life and End Stage Renal Disease, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™) (time frame: 0 weeks, 8 weeks, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.