Chronic Kidney DiseasesDARTNCT03522740
Decision Aid for Renal Therapy
A study testing Decision Aid for Renal Therapy in people with Chronic Kidney Diseases and Kidney Failure, Chronic, run by Tufts University at 4 sites in United States.
Trial summary
Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Failure, Chronic
- What is being tested?
- Decision Aid for Renal Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 May 2018to 21 Sep 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- CKD stages 4 or 5 (non-dialysis) without an established dialysis start or transplant date within three months of expected randomization;
- Age >70 (with no upper limit);
- English speaking;
- Willingness to be randomized to DART; and
- Able to sign informed consent.
Who cannot join
- death, dialysis initiation or transplant deemed highly likely within the next three months by the patient's nephrologist
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern University
Chicago, Illinois, 60611
Maine Medical Center
Portland, Maine, 04102
University of California San Diego
San Diego, California, 92103
About this study
Official title: Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know all of their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, the investigators are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.
The DART study will be conducted at four sites in different areas of the country: Boston, Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will enroll a total of 400 people with kidney disease at these four sites.
Read the detailed description
Aligning patient preferences (goals of care and values) with treatment is essential for quality health care. Treatment of life-limiting illness is especially preference-sensitive, where high-intensity care often offers marginal survival benefit but can worsen quality of life. Elderly persons with advanced chronic kidney disease (CKD) may face a choice between high-intensity dialysis and low-intensity conservative management (CM). This decision is of special import because it is often irreversible as dialysis itself can diminish residual kidney function. In adults over 70 years-old with advanced CKD, dialysis on average confers only marginally better survival than medical management while reducing independence and mobility and increasing medical procedures. Poor communication about benefits and risks of treatment options available to these patients results in decisional conflict: a state of uncertainty associated with making a choice that best reflects values and preferences. However, it is unclear how to best educate patients and their care-partners about their treatment choices and the importance of advance care planning.
The objective of this trial is to compare the effectiveness of two widely used strategies, in-person education alone versus in-person education plus an interactive web-based decision aid, in: 1) reducing decisional conflict and empowering patients and care-partners to select treatment aligned with patient preferences; and 2) improving care-partners' ability to confidently and accurately express patients' preferences when patients are unable (proxy decision-making).
The hypothesis is that, compared to traditional in-person education, use of the Decision Aid for Renal Therapy (DART) will decrease decisional conflict, increase completion of advance directives, improve patient and caregiver satisfaction with treatment (quantitative outcomes), and contribute to greater patient engagement, satisfaction with decision-making, and care-partner concordance (qualitative and quantitative outcomes).
DART is a web-based multimedia decision-aid that is designed to be accessible to individuals with limited health literacy. The investigators will evaluate whether use of DART results in greater patient understanding of options, leading to better discussions with care providers, and ultimately lower decisional conflict and greater completion of advanced directives compared with the comparator, in-person education. DART is replicable, consistent, can be shared with care-partners, and can be viewed in the comfort of the patient's home.
This randomized clinical trial targeting 400 older adults with advanced kidney disease and as many as 400 of their care-partners compares the effectiveness of DART plus in-person education to in-person education alone for reducing decisional conflict and increasing completion of advance care plans (ACPs) among older adults with advanced CKD and their care-partners. Patients and patient-care-partner pairs will be surveyed at baseline for goals of care, life goals, health literacy, patient activation, end-of-life (EOL) preferences and baseline scores on other study outcome measures, and followed at 3- to 6-month intervals for up to 18 months, censoring at dialysis, death or study end, to collect data on decisional conflict and completion of advance directives as well as QOL, satisfaction, dyad concordance and medical events, such as dialysis initiation.
- Conditions
- Chronic Kidney Diseases, Kidney Failure, Chronic
- Being tested
- Decision Aid for Renal Therapy
- Keywords
- Chronic Kidney Disease, Chronic Kidney Failure, Palliative Care, Dialysis, End-of-life care, Decision making
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid for Renal TherapyOther
DART is a web-based decision aid that informs older adults with advanced kidney disease of kidney disease treatment options and prompts them to consider their preferences and raise questions to discuss with their kidney disease providers.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid for Renal Therapy | Active comparator | Usual Care as in the 'no intervention arm' below plus access to an web-based decision aid, the Decision Aid for Renal Therapy to patients and their care-partners Receives: Other: Decision Aid for Renal Therapy |
| Usual Care | No intervention | In-person education as would be done at study sites plus 'Choosing a Treatment for Kidney Failure', an educational booklet published by the National Kidney Foundation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
The decisional conflict scale (DCS) measures personal perceptions of:
- Uncertainty in choosing options; and
- Modifiable factors contributing to uncertainty.
The low literacy version of the DCS contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no.
The total DCS score is the sum of the 10 items, multiplied by 2.5. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
The DCS can be conceptualized as subscores, which will be examined as a part of this study, and are normalized to a 0 to 100 score as above. These include the following:
- Uncertainty subscore: 2 items (questions 9 and 10)
- Informed subscore: 3 items (questions 1, 2, and 3)
- Values clarity subscore: 2 items (questions 4 and 5)
- Support subscore: 3 items (questions 6, 7, and 8)
Reference: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
Measured: 3 months
Secondary outcomes (6)
Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
The decisional conflict scale (DCS) measures personal perceptions of:
- Uncertainty in choosing options; and
- Modifiable factors contributing to uncertainty.
The low literacy version of the DCS contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no.
The total DCS score is the sum of the 10 items, multiplied by 2.5. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
The DCS can be conceptualized as subscores, which will be examined as a part of this study, and are normalized to a 0 to 100 score as above. These include the following:
- Uncertainty subscore: 2 items (questions 9 and 10)
- Informed subscore: 3 items (questions 1, 2, and 3)
- Values clarity subscore: 2 items (questions 4 and 5)
- Support subscore: 3 items (questions 6, 7, and 8)
Reference: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
Measured: Up to 18 months
Advance Directive Completion
Completion of an advance directive, Physician Orders for Life-Sustaining Treatment (POLST), or both among patient-participants ascertained by participant query and/or chart review.
Measured: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
Change in score on the CANHELP Lite Patient Questionnaire version 11 Nov 2014 for patient-participants.
The CANHELP Lite Patient Questionnaire includes 21 items. One is a general question while the other 20 items inform 5 domains:
Domain #1: Relationship with doctors: Questions 2, 3, and 4 Domain #2: Illness Management: Q5 - 13 Domain #3: Communication: Q13 - 16 Domain #4: Decision Making: Q17 - 20 Domain #5: Feeling at Peace: Q21 Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.
Ref: Heyland et al. J Pain Symptom Manage. 2013
Measured: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
Change in score on the CANHELP Lite Caregiver Questionnaire 11 Nov 2014 for carepartner participants.
The CANHELP Lite Caregiver Questionnaire includes 23 items. Two are general questions while the remaining 21 items inform 5 domains:
Domain #1: Relationship with doctors: Questions 3 - 5 Domain #2: Characteristics of Doctors and Nurses: Q6-7 Domain #3: Illness Management: Q8-16 Domain #4: Communication and Decision Making: Q17-20 Domain #5: Your Involvement: Q21-23
Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.
Ref: Heyland et al. J Pain Symptom Manage. 2013
Measured: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
Change in score on the CANHELP Lite Patient Questionnaire version 11 Nov 2014 for patient-participants.
The CANHELP Lite Patient Questionnaire includes 21 items. One is a general question while the other 20 items inform 5 domains:
Domain #1: Relationship with doctors: Questions 2, 3, and 4 Domain #2: Illness Management: Q5 - 13 Domain #3: Communication: Q13 - 16 Domain #4: Decision Making: Q17 - 20 Domain #5: Feeling at Peace: Q21 Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.
Ref: Heyland et al. J Pain Symptom Manage. 2013
Measured: Up to 18 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
Change in score on the CANHELP Lite Caregiver Questionnaire 11 Nov 2014 for carepartner participants.
The CANHELP Lite Caregiver Questionnaire includes 23 items. Two are general questions while the remaining 21 items inform 5 domains:
Domain #1: Relationship with doctors: Questions 3 - 5 Domain #2: Characteristics of Doctors and Nurses: Q6-7 Domain #3: Illness Management: Q8-16 Domain #4: Communication and Decision Making: Q17-20 Domain #5: Your Involvement: Q21-23
Questions are scored on a 5-point scale, ranging from 'Not at All' to 'Completely'. The Overall Score is the unweighted average of all answered questions. Individual domain scores are the unweighted average of non-missing questions specific to each domain. All scores are subsequently re-scaled to range between 0 (worst possible value) and 100 (best possible value). The Overall Score will be the focus of analyses.
Ref: Heyland et al. J Pain Symptom Manage. 2013
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start30 May 2018
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Keren Ladin, Tufts University
- Investigators
- Daniel E Weiner, MD, Principal investigator, Tufts Medical Center and Tufts UniversityKeren Ladin, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522740
- Sponsor's protocol ID
- 12890
- Acronym
- DART
- Status last verified
- Apr 2022
- First submitted
- 1 May 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzales KM, Koch-Weser S, Kennefick K, Lynch M, Porteny T, Tighiouart H, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Weiner DE, Ladin K. Decision-Making Engagement Preferences among Older Adults with CKD. J Am Soc Nephrol. 2024 Jun 1;35(6):772-781. doi: 10.1681/ASN.0000000000000341. Epub 2024 Mar 22.
PubMed 38517479Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, Wong JB, Levine S, Agarwal A, Ren L, Degnan J, Sewall LN, Kuramitsu B, Fox P, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE. Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):29-38. doi: 10.7326/M22-1543. Epub 2022 Dec 20.
PubMed 36534976Porteny T, Gonzales KM, Aufort KE, Levine S, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Di Perna G, Koch-Weser S, Weiner DE, Ladin K; Stakeholder Advisory Board. Treatment Decision Making for Older Kidney Patients during COVID-19. Clin J Am Soc Nephrol. 2022 Jul;17(7):957-965. doi: 10.2215/CJN.13241021. Epub 2022 Jun 7.
PubMed 35672037
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
- ClinicalTrials.gov ID
- NCT03522740
- Acronym / sponsor ID
- DART / 12890
- Conditions
- Chronic Kidney Diseases, Kidney Failure, Chronic
- Keywords
- Chronic Kidney Disease, Chronic Kidney Failure, Palliative Care, Dialysis, End-of-life care, Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 30 May 2018 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 11 May 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.
Good communication among patients, their families and loved ones, and their medical care providers is important when figuring out how to treat chronic diseases like kidney disease. A lot of people may not know all of their choices for how to treat kidney disease, and this can lead to rushed decisions or even a sense that there weren't any choices to make. In this study, the investigators are trying to find out if a decision-aid program on a computer can help people with kidney disease have more confidence in their decisions and have better agreement about their decisions with their families and loved ones.
The DART study will be conducted at four sites in different areas of the country: Boston, Massachusetts; Portland, Maine; Chicago, Illinois; and San Diego, California. The study will enroll a total of 400 people with kidney disease at these four sites.
Detailed description
Aligning patient preferences (goals of care and values) with treatment is essential for quality health care. Treatment of life-limiting illness is especially preference-sensitive, where high-intensity care often offers marginal survival benefit but can worsen quality of life. Elderly persons with advanced chronic kidney disease (CKD) may face a choice between high-intensity dialysis and low-intensity conservative management (CM). This decision is of special import because it is often irreversible as dialysis itself can diminish residual kidney function. In adults over 70 years-old with advanced CKD, dialysis on average confers only marginally better survival than medical management while reducing independence and mobility and increasing medical procedures. Poor communication about benefits and risks of treatment options available to these patients results in decisional conflict: a state of uncertainty associated with making a choice that best reflects values and preferences. However, it is unclear how to best educate patients and their care-partners about their treatment choices and the importance of advance care planning.
The objective of this trial is to compare the effectiveness of two widely used strategies, in-person education alone versus in-person education plus an interactive web-based decision aid, in: 1) reducing decisional conflict and empowering patients and care-partners to select treatment aligned with patient preferences; and 2) improving care-partners' ability to confidently and accurately express patients' preferences when patients are unable (proxy decision-making).
The hypothesis is that, compared to traditional in-person education, use of the Decision Aid for Renal Therapy (DART) will decrease decisional conflict, increase completion of advance directives, improve patient and caregiver satisfaction with treatment (quantitative outcomes), and contribute to greater patient engagement, satisfaction with decision-making, and care-partner concordance (qualitative and quantitative outcomes).
DART is a web-based multimedia decision-aid that is designed to be accessible to individuals with limited health literacy. The investigators will evaluate whether use of DART results in greater patient understanding of options, leading to better discussions with care providers, and ultimately lower decisional conflict and greater completion of advanced directives compared with the comparator, in-person education. DART is replicable, consistent, can be shared with care-partners, and can be viewed in the comfort of the patient's home.
This randomized clinical trial targeting 400 older adults with advanced kidney disease and as many as 400 of their care-partners compares the effectiveness of DART plus in-person education to in-person education alone for reducing decisional conflict and increasing completion of advance care plans (ACPs) among older adults with advanced CKD and their care-partners. Patients and patient-care-partner pairs will be surveyed at baseline for goals of care, life goals, health literacy, patient activation, end-of-life (EOL) preferences and baseline scores on other study outcome measures, and followed at 3- to 6-month intervals for up to 18 months, censoring at dialysis, death or study end, to collect data on decisional conflict and completion of advance directives as well as QOL, satisfaction, dyad concordance and medical events, such as dialysis initiation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid for Renal Therapy | Active comparator | Other: Decision Aid for Renal TherapyUsual Care as in the 'no intervention arm' below plus access to an web-based decision aid, the Decision Aid for Renal Therapy to patients and their care-partners |
| Usual Care | No intervention | –In-person education as would be done at study sites plus 'Choosing a Treatment for Kidney Failure', an educational booklet published by the National Kidney Foundation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- CKD stages 4 or 5 (non-dialysis) without an established dialysis start or transplant date within three months of expected randomization;
- Age >70 (with no upper limit);
- English speaking;
- Willingness to be randomized to DART; and
- Able to sign informed consent.
Key exclusion criteria (1 listed)
- death, dialysis initiation or transplant deemed highly likely within the next three months by the patient's nephrologist
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 |
|---|---|---|
| Decision Aid for Renal TherapyDART is a web-based decision aid that informs older adults with advanced kidney disease of kidney disease treatment options and prompts them to consider their preferences and raise questions to discuss with their kidney disease providers. | Other | Decision Aid for Renal Therapy |
Primary outcome
Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
Time frame: 3 months
The decisional conflict scale (DCS) measures personal perceptions of: 1. Uncertainty in choosing options; and 2. Modifiable factors contributing to uncertainty. The low literacy version of the DCS contains 10 items scored on a 3 point scale, with 0 points given for an answer of yes, 2 for an answer of unsure, and 4 for an answer of no. The total DCS score is the sum of the 10 items, multiplied by 2.5. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) The DCS can be conceptualized as subscores, which will be examined as a part of this study, and are normalized to a 0 to 100 score as above. These include the following: 1. Uncertainty subscore: 2 items (questions 9 and 10) 2. Informed subscore: 3 items (questions 1, 2, and 3) 3. Values clarity subscore: 2 items (questions 4 and 5) 4. Support subscore: 3 items (questions 6, 7, and 8) Reference: https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
6 secondary outcomes
Change in score for patient-participants on the Decisional Conflict Scale, Low Literacy Version
Time frame: Up to 18 months
Advance Directive Completion
Time frame: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
Time frame: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
Time frame: 3 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Patients
Time frame: Up to 18 months
Canadian Health Care Evaluation Project (CANHELP) Questionnaire Score, Carepartners
Time frame: Up to 18 months
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 27 Apr 2022.
- Derived from this study: PubMed 38517479Gonzales KM, Koch-Weser S, Kennefick K, Lynch M, Porteny T, Tighiouart H, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Weiner DE, Ladin K. Decision-Making Engagement Preferences among Older Adults with CKD. J Am Soc Nephrol. 2024 Jun 1;35(6):772-781. doi: 10.1681/ASN.0000000000000341. Epub 2024 Mar 22.
- Derived from this study: PubMed 36534976Ladin K, Tighiouart H, Bronzi O, Koch-Weser S, Wong JB, Levine S, Agarwal A, Ren L, Degnan J, Sewall LN, Kuramitsu B, Fox P, Gordon EJ, Isakova T, Rifkin D, Rossi A, Weiner DE. Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial. Ann Intern Med. 2023 Jan;176(1):29-38. doi: 10.7326/M22-1543. Epub 2022 Dec 20.
- Derived from this study: PubMed 35672037Porteny T, Gonzales KM, Aufort KE, Levine S, Wong JB, Isakova T, Rifkin DE, Gordon EJ, Rossi A, Di Perna G, Koch-Weser S, Weiner DE, Ladin K; Stakeholder Advisory Board. Treatment Decision Making for Older Kidney Patients during COVID-19. Clin J Am Soc Nephrol. 2022 Jul;17(7):957-965. doi: 10.2215/CJN.13241021. Epub 2022 Jun 7.
- 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.
Daniel E Weiner, MD principal investigator
Tufts Medical Center and Tufts University
Keren Ladin, PhD principal investigator
Tufts University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid for Renal Therapy in people with Chronic Kidney Diseases and Kidney Failure, Chronic, run by Tufts University at 4 sites 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 1 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 for patient-participants on the Decisional Conflict Scale, Low Literacy Version (time frame: 3 months). 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 NCT03522740, which also lists 3 linked publications.
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 27 Apr 2022.