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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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Feasibility pilot social support counseling intervention for kidney transplant candidates
Individuals who are eligible for kidney transplant will be randomized into two groups, control and interventional counseling. The control group will be given a simple survey to fill and return while the interventional counseling will go through a second counseling session along with members of their social support networks. The interventional counseling will then complete the survey (same as control group). Survey answers will be recorded within REDCAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Pre-Transplant Counseling Intervention | No Intervention | Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. | |
| Social Support Network Counseling Intervention | Experimental | Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social support network counseling intervention | Behavioral | Pilot social support counseling intervention for kidney transplant candidates along with their social support networks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question key (true/false, multiple choice)
| one month |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Decisional Conflict Scores | questionnaire (Ottawa Decisional Conflict scale) | one month |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute | Minneapolis | Minnesota | 55415 | United States |
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| Label | URL |
|---|---|
| American Transplant Congress oral abstract | View source |
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There might be an exchange of data with our collaborators with the study at the University of Minnesota-Twin Cities
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Participants for the feasibility pilot trial were recruited from two transplant centers in Minnesota, Hennepin Healthcare and The University of Minnesota, between August 2020 and March 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Pre-Transplant Counseling Intervention | Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
| FG001 | Social Support Network Counseling Intervention | Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Pre-Transplant Counseling Intervention | Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
| BG001 | Social Support Network Counseling Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Correct Answers on Knowledge of Kidney Transplant Options Assessment | Question key (true/false, multiple choice)
| Posted | Count of Participants | Participants | one month |
|
No adverse event data were collected.
No mortality, serious, or other adverse events were monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Pre-Transplant Counseling Intervention | Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allyson Hart | Hennepin Healthcare Research Institute | 612-873-6998 | allyson.hart@hcmed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2024 | Oct 1, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | Oct 1, 2024 | SAP_001.pdf |
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A control group versus interventional group. Interventional group and their social support network will complete questionnaire.
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This is a pilot feasibility study, but statisticians will be blinded to group assignment when assessing outcomes
Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling
Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| OG000 |
| Usual Pre-Transplant Counseling Intervention |
Subjects in the control arm will undergo usual pre-transplant counseling as per the standard of care. |
| OG001 | Social Support Network Counseling Intervention | Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks |
|
|
| Secondary | Difference in Decisional Conflict Scores | questionnaire (Ottawa Decisional Conflict scale) | Posted | Count of Participants | Participants | one month |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Social Support Network Counseling Intervention | Subjects in the intervention arm will undergo an additional pretransplant counseling session along with members of their social support networks between 2-12 weeks after their initial transplant evaluation and counseling Social support network counseling intervention: Pilot social support counseling intervention for kidney transplant candidates along with their social support networks | 0 | 0 | 0 | 0 | 0 | 0 |
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| Do you know the benefits and risks of getting a kidney transplant? |
|
| Are you clear about which benefits and risks matter most to you? |
|
| Do you have enough support and advice to make a choice? |
|