End-stage Renal DiseasePhase 2/3NCT00428012
Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
A Phase 2/3 study testing Quality of Life Therapy and Supportive Therapy in people with End-stage Renal Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiting kidney transplantation. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Quality of Life Therapy and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Apr 2011
- Phase
- Phase 2/3
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between 21 and 70 years of age
- Diagnosis of ESRD
- Wait-listed for deceased donor renal transplantation (primary transplant only)
- White or African American race
- Signed informed consent
- Primary caregiver identified as spouse or domestic partner
- Resides within 60 minutes of transplant center
Who cannot join
- Prior recipient of renal transplantation
- Prior recipient of other solid organ transplantation
- Wait-listed for combined kidney-pancreas transplantation
- Current substance abuse or dependency
- Currently hospitalized
- Current recipient of psychological intervention services
Show all 9Show fewer
- Mental retardation
- Substantial cognitive impairment (score of 23 or less on the Mini-Mental State Examination)
- Communication difficulties (speech, hearing) so substantial that they would prevent patient from participating actively in one of the interventions (determined by transplant social worker)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Transplant Center, Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiting kidney transplantation.
Read the detailed description
Despite known quality of life (QOL) deficits associated with end-stage renal disease (ESRD), there have been very few attempts to develop strategies to improve QOL in adults with ESRD awaiting renal transplantation. The long-term goal of this research program is to better understand how QOL can be enhanced, to identify the mechanisms underlying QOL changes, to identify which patients benefit most from QOL intervention, and to determine whether QOL benefits can extend beyond transplantation. The objective of this research is to determine the effectiveness, feasibility and applicability of Quality of Life Therapy (QOLT) in treating adults with ESRD awaiting renal transplantation. In a recent small, single-center clinical trial, we demonstrated that QOLT can improve QOL, psychological functioning, and social intimacy in patients awaiting lung transplantation. We now seek to examine whether this intervention can be effectively adapted and implemented with adults with ESRD who are awaiting renal transplantation. The central hypothesis is that by targeting improvements in specific life domains, QOLT yields significant clinical benefits in QOL, psychological functioning, and the patient-caregiver relationship. This hypothesis is being tested by pursuing three specific aims: 1) Determine the effectiveness of QOLT; 2) Examine the differential effectiveness of QOLT by race (White, African American); and 3) Assess the feasibility of a multisite R01 application. Under the first aim, adults with ESRD awaiting renal transplantation are being randomized to receive QOLT, Supportive Therapy (ST), or Standard Care (SC). Primary outcomes are changes in QOL, psychological functioning, and social intimacy at 1 and 12 weeks post-treatment. Under the second aim, the relationship between race and intervention outcomes will be closely examined. Under the third aim, attrition rates, reasons for attrition, therapist adherence to treatment protocols, and participant satisfaction ratings are being gathered to assess the need for protocol changes prior to developing a larger, multisite clinical trial R01 application. This study is innovative because it is among the first to evaluate a theoretically-driven psychological intervention to specifically improve QOL in the context of ESRD and renal transplantation. The research is significant because it is expected to advance and expand understanding of how QOL can be improved in patients with ESRD.
- Conditions
- End-stage Renal Disease
- Being tested
- Quality of Life Therapy, Supportive Therapy
- Keywords
- quality of life, kidney transplantation
- 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.
Quality of Life TherapyBehavioural
8 weekly individual counseling sessions
Supportive TherapyBehavioural
8 weekly individual counseling sessions
| Study group | Role | What they receive |
|---|---|---|
| QOLT | Experimental | Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions Receives: Behavioral: Quality of Life Therapy |
| ST | Active comparator | Supportive Therapy (ST) 8 weekly individual counseling sessions Receives: Behavioral: Supportive Therapy |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, KDQoL, CDC Activity Limitations Module, Hopkins Symptom Checklist, POMS, and Miller Social Intimacy Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Rodrigue, Beth Israel Deaconess Medical Center
- Investigators
- James R. Rodrigue, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428012
- Sponsor's protocol ID
- R21 DK77322 (completed)
- Other IDs
- R21DK077322
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2007
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
- ClinicalTrials.gov ID
- NCT00428012
- Acronym / sponsor ID
- R21 DK77322 (completed)
- Conditions
- End-stage Renal Disease
- Keywords
- quality of life, kidney transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 29 Jan 2007 (estimated)
- 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.
The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiting kidney transplantation.
Detailed description
Despite known quality of life (QOL) deficits associated with end-stage renal disease (ESRD), there have been very few attempts to develop strategies to improve QOL in adults with ESRD awaiting renal transplantation. The long-term goal of this research program is to better understand how QOL can be enhanced, to identify the mechanisms underlying QOL changes, to identify which patients benefit most from QOL intervention, and to determine whether QOL benefits can extend beyond transplantation. The objective of this research is to determine the effectiveness, feasibility and applicability of Quality of Life Therapy (QOLT) in treating adults with ESRD awaiting renal transplantation. In a recent small, single-center clinical trial, we demonstrated that QOLT can improve QOL, psychological functioning, and social intimacy in patients awaiting lung transplantation. We now seek to examine whether this intervention can be effectively adapted and implemented with adults with ESRD who are awaiting renal transplantation. The central hypothesis is that by targeting improvements in specific life domains, QOLT yields significant clinical benefits in QOL, psychological functioning, and the patient-caregiver relationship. This hypothesis is being tested by pursuing three specific aims: 1) Determine the effectiveness of QOLT; 2) Examine the differential effectiveness of QOLT by race (White, African American); and 3) Assess the feasibility of a multisite R01 application. Under the first aim, adults with ESRD awaiting renal transplantation are being randomized to receive QOLT, Supportive Therapy (ST), or Standard Care (SC). Primary outcomes are changes in QOL, psychological functioning, and social intimacy at 1 and 12 weeks post-treatment. Under the second aim, the relationship between race and intervention outcomes will be closely examined. Under the third aim, attrition rates, reasons for attrition, therapist adherence to treatment protocols, and participant satisfaction ratings are being gathered to assess the need for protocol changes prior to developing a larger, multisite clinical trial R01 application. This study is innovative because it is among the first to evaluate a theoretically-driven psychological intervention to specifically improve QOL in the context of ESRD and renal transplantation. The research is significant because it is expected to advance and expand understanding of how QOL can be improved in patients with ESRD.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QOLT | Experimental | Behavioral: Quality of Life TherapyQuality of Life Therapy (QOLT) 8 weekly individual counseling sessions |
| ST | Active comparator | Behavioral: Supportive TherapySupportive Therapy (ST) 8 weekly individual counseling sessions |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients between 21 and 70 years of age
- Diagnosis of ESRD
- Wait-listed for deceased donor renal transplantation (primary transplant only)
- White or African American race
- Signed informed consent
Key exclusion criteria (9 listed)
- Prior recipient of renal transplantation
- Prior recipient of other solid organ transplantation
- Wait-listed for combined kidney-pancreas transplantation
- Current substance abuse or dependency
- Currently hospitalized
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 |
|---|---|---|
| Quality of Life Therapy8 weekly individual counseling sessions | Behavioural | QOLT |
| Supportive Therapy8 weekly individual counseling sessions | Behavioural | ST |
Primary outcome
Primary: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, KDQoL, CDC Activity Limitations Module, Hopkins Symptom Checklist, POMS, and Miller Social Intimacy Scale
Time frame: 12 weeks
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 6 Jan 2012.
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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.
James R. Rodrigue, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quality of Life Therapy and Supportive Therapy in people with End-stage Renal Disease, run by Beth Israel Deaconess Medical Center 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 7 inclusion and 9 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 6 Jan 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, KDQoL, CDC Activity Limitations Module, Hopkins Symptom Checklist, POMS, and Miller Social Intimacy Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2012.