Chronic Kidney Diseases Clinical Trial
— DARTOfficial title:
Decision Aid for Renal Therapy: Promoting Knowledge and Autonomy in Chronic Kidney Disease Patients and Their Care-Partners
NCT number | NCT03522740 |
Other study ID # | 12890 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2018 |
Est. completion date | September 21, 2021 |
Verified date | April 2022 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | September 21, 2021 |
Est. primary completion date | September 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - death, dialysis initiation or transplant deemed highly likely within the next three months by the patient's nephrologist |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Northwestern University | Chicago | Illinois |
United States | Maine Medical Center | Portland | Maine |
United States | University of California San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Tufts University | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Instability of Patient Preferences | A reversal of the post-intervention decision (dialysis or conservative management) from the first visit after DART/3month follow-up and study completion | Up to 18 months | |
Other | Patient/Care-Partner Concordance | Goal concordance as assessed on the goals of care survey | Up to 18 months | |
Primary | 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 |
3 months | |
Secondary | 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 |
Up to 18 months | |
Secondary | 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. | 3 months | |
Secondary | 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 |
3 months | |
Secondary | 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 |
3 months | |
Secondary | 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 |
Up to 18 months | |
Secondary | 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 |
Up to 18 months |
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