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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK118471 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This project tests a peer mentor intervention to improve outcomes in patients with end-stage renal disease (ESRD). The investigators will train peer mentors to deliver social support and to provide information and motivation in order to improve adherence behaviors and self management practices in assigned mentees who are also patients on maintenance hemodialysis. The intervention will consist of a weekly telephone call between mentor and mentee, over a period of 3 months. The study will recruit patients at 7 dialysis facilities (5 in the Bronx, NY and 2 in Nashville, TN) and randomize the patients to the peer mentorship intervention versus usual care. The primary outcome will be the sum of number of emergency department visits and hospitalizations during 3 months of intervention and 9 or 15 months of follow-up observation.
The overarching goal of this research is to improve End Stage Renal Disease (ESRD) related morbidity and mortality. The medical care of patients with ESRD is highly complex and enormously expensive. Hospitalizations drive up to 40% of the cost for ESRD care. Cardiovascular disease and infections account for over 50% of ESRD-related hospitalizations and contribute to disproportionate mortality in this patient population. This study tests the implementation and impact on hospitalization outcomes of a peer mentor led intervention designed to increase effective self-management in patients receiving hemodialysis, in a real-world setting with high potential for widespread dissemination.
Patients receiving hemodialysis who can self-manage their fluid status effectively, are adherent to their dialysis schedule and to their dietary plan are hospitalized less frequently and have lower morbidity and mortality than patients who are less adherent. However, numerous impediments to dialysis self-management exist including facility, physician and patient-level barriers. The following are patient-level barriers to optimal self-management: 1) poor knowledge about the rationale and metrics of estimated dry weight (EDW), 2) poor knowledge about the metrics of urea clearance and nutritional parameters, 3) under-utilization of available hours for unscheduled dialysis, and 4) low self-efficacy leading to non-adherent schedule and dietary behaviors. Dialysis self-management education is often not successful in improving patients' skills. Educational tools from dialysis facilities and providers are didactic, have medical jargon and lack concrete steps to mitigate patient visits to emergency departments (ED) and subsequent hospitalizations. A culturally sensitive, easy to understand educational program that can increase hemodialysis self-management is critically needed.
Peer mentorship has been used effectively to enhance self-efficacy and self-management behaviors in patients with chronic disease. A single study of peer mentorship for ESRD patients found that peer mentors improved adherence and satisfaction with care among mentees. This strategy has high potential to improve the factors that drive hospitalizations among this high-risk patient group. The goal of this research is to implement a peer mentor training program to increase patients' knowledge about the metrics of hemodialysis, enhance self-management to meet EDW, nutritional and adherence goals, and to enhance self-efficacy in mentees. The peer-mentor intervention is based on the information, motivation, behavior (IMB) model of health behavior and the Chronic Disease Self-Management Program. There will be a didactic component to increase knowledge, and a semi-structured component to increase perception of social support. The investigators will test the feasibility of implementation of this program and the efficacy of it to reduce hospitalizations in a pragmatic trial comparing the peer mentor intervention on mentees to a control group assigned to usual care. The study will also test the intervention at two geographically diverse locations (Bronx, NY and Nashville, TN) to provide evidence of its scalability and acceptability in different patient populations. The study hypothesis states: a structured peer mentor telephone intervention will be more effective than usual care in increasing hemodialysis related knowledge, self-management adherent behaviors and in decreasing ED visits and hospitalizations in ESRD.
Specific Aim 1: To evaluate the effects of a 3-month semi-structured and telephone delivered peer mentor intervention on a composite of ED visits and hospitalizations in 100 high risk patients on hemodialysis randomized to peer mentor intervention as compared to 100 high risk patients on hemodialysis assigned to usual care.
Specific Aim 2: To test the feasibility of a peer training program focused on teaching self-management skills focused on adherence, dietary and fluid management, in dialysis facilities.
This pragmatic trial will test the effects and implementation of a low cost, educational, telephone-based, peer-mentor intervention to increase self-management behaviors of patients receiving hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer mentorship intervention | Experimental | This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. |
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| Usual Care | No Intervention | This arm of mentees will not get a telephone intervention by an assigned mentee |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer mentorship | Behavioral | Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis. |
| Measure | Description | Time Frame |
|---|---|---|
| ED Visits and Hospitalizations | Each month all enrolled patients will be evaluated for ED visit or hospitalization encounters by both self-report and medical record review. The events will be tabulated each month up to an 18-month period. The rates of the composite event during this period will be determined as event rate per patient-month. | During 3 months of intervention and up to 15 months of follow up (up to 18 months observation total) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes | Average change in number of monthly minutes of dialysis missed by intervention participants as compared to usual care participants over the study period. | up to 18 months |
| Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Dialysis Specific Social Support by Intervention Mentees as Compared to Usual Care Mentees | Change from baseline in Dialysis Specific Social Support was assessed using the Dialysis Specific Support Survey (developed by PI's). This survey was used to characterize the frequency of interactions between the participant and other dialysis patients. This survey consists of 6 items and the total score is the mean of the 6 items. Individual scores for the scale ranged from 1-5 where 1 = ("None of the time") and 5 = ("All of the time"), yielding a possible scoring range of 1-5. For this study, mean change from baseline score is reported. A positive mean score was reflective of more perceived dialysis social support; whereas, a negative mean score was reflective of less perceived dialysis social support. |
Inclusion Criteria:
One of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine/Montefiore Medical Center | The Bronx | New York | 10467 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35247960 | Derived | Golestaneh L, Melamed M, Kim RS, St Clair Russell J, Heisler M, Villalba L, Perry T, Cavanaugh KL. Peer mentorship to improve outcomes in patients on hemodialysis (PEER-HD): a randomized controlled trial protocol. BMC Nephrol. 2022 Mar 5;23(1):92. doi: 10.1186/s12882-022-02701-1. |
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Mentors were not included in the trial. Patient participants or mentees were the subjects who were followed for the primary and secondary outcomes. Mentors implemented the intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer Mentorship Intervention | This arm of mentees will be assigned to weekly telephone calls with a matched mentor over a period of 3 months. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis. |
| FG001 | Usual Care | This arm of mentees will not get a telephone intervention by an assigned mentee |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data available and provided for the 194 participants who completed the protocol.
Mentors were not included in the trial. Patient participants or mentees were the subjects who were followed for the primary and secondary outcomes. Mentors implemented the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer Mentorship Intervention | This arm of patient participants will be assigned to weekly telephone calls with an assigned mentor over a period of 3 months. They will have observational follow up for 9-15 months thereafter. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake, how to improve understanding of and adherence to dialysis. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | ED Visits and Hospitalizations | Each month all enrolled patients will be evaluated for ED visit or hospitalization encounters by both self-report and medical record review. The events will be tabulated each month up to an 18-month period. The rates of the composite event during this period will be determined as event rate per patient-month. | Patient participants receiving maintenance dialysis | Posted | Mean | 95% Confidence Interval | cases per person-months | During 3 months of intervention and up to 15 months of follow up (up to 18 months observation total) |
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Adverse events were collected from time of enrollment (baseline visit) through 12-18 months of follow up or time at which patient participants and mentees were censored.
Participants with hospitalizations or ED visits. Non-serious adverse events were only collected for those instances where:
The trial examined outcomes in patient participants and not mentors. Mentors implemented the intervention: peer mentorship.
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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 | Peer Mentorship Intervention | This arm of patient participants will be assigned to weekly telephone calls with an assigned mentor over a period of 3 months. They will have observational follow up for 9-15 months thereafter. Peer mentorship: Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake, how to improve understanding of and adherence to dialysis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ladan Golestaneh | Albert Einstein College of Medicine | 718-920-5442 | lgolesta@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 | Sep 19, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2022 | Sep 20, 2023 | ICF_001.pdf |
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Change in monthly average fluid weight gain in-between dialysis treatments by intervention participants as compared to usual care participants over study period. |
| up to 18 months |
| Change From Baseline in Average Monthly Serum Albumin Levels | Change in mean monthly albumin levels in intervention mentees as compared to control mentees over follow up period. | up to 18 months |
| Efficacy of Intervention to Change Dialysis Knowledge in Mentees | Efficacy of intervention to change dialysis knowledge will be assessed based on the Score on Chronic Hemodialysis Knowledge Survey (CHeKs) in patient participants assigned to the peer-mentor intervention as compared patient participants assigned to usual care. Mean change in baseline scores are reported. The CHeKs survey consists of 23 multiple choice questions. Total score is determined by summing all correct items (blank items or items with more than one answer are considered incorrect). A positive mean percentage score is indicative of an improvement from baseline and demonstrated increased participant knowledge of hemodialysis care; whereas, a negative mean percentage score is indicative of decrease in demonstrated hemodialysis knowledge. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Efficacy of Intervention to Change Curriculum Specific Dialysis Knowledge in Patient Participants | Efficacy of intervention to change curriculum specific dialysis knowledge in patient participants was assessed based on a change from baseline in score on the "Chronic Hemodialysis Knowledge Survey (CHeKs) Plus" knowledge assessment, an assessment developed by the study team focused on topic covered in mentor training sessions, in patient-participants assigned to intervention as compared patient participants assigned to usual care. The CHeKs Plus survey is a multiple-choice training quiz which contains 8 questions. A mean change from baseline score was reported for the groups. A positive mean change demonstrated an improvement in specific hemodialysis knowledge; whereas, a decrease in score is indicative of decrease in specific hemodialysis knowledge. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Change From Baseline in General Health (GH) Perceptions Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in General Health will be assessed using the GH perceptions subscale domain of the RAND SF-36 QoL Health Survey. The GH subscale consists of 5 specific items (Items 1 and 33-36) of the health survey. Item 1 is scored on a 5 point scale ranging from 1 ("Excellent") to 5 ("Very Poor") and items 33-36 are scored on a 5 point scale ranging from 1 ("Definitely True") to 5 ("Definitely False"). Responses are then coded to the RAND scoring key for the respective items as follows: Items 1, 34, and 36 are inversely coded such that a precoded item value of 1 ("Excellent" or "Definitely True") is assigned a final item value of "5" and so forth. Items 33 and 35 maintain the same final item value as precoded item value. This yields an overall scoring range of 5-25 for final value items. No transformation was done. For this measure a mean change from baseline for GH is calculated. A positive mean score is indicative of improved self-perception of general health from baseline. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Change From Baseline in Physical Functioning (PF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in Physical Functioning (PF) will be assessed using the PF subscale domain of the RAND SF-36 QoL Health Survey. The PF subscale consists of 10 specific items (Items 3-12) of the health survey. These items are scored on a 3 point scale ranging from 1 ("Yes, limited a lot") to 3 ("No, not limited at all") The raw responses values and coded final item values are identical yielding an overall scoring range of 10-30 for final value items. No additional transformation is done. For this measure a mean change from baseline for PF is calculated. A positive mean score is associated with an improved self-perception of physical functioning from baseline. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Change From Baseline in Social Functioning (SF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in Social Functioning (SF) will be assessed using the SF subscale domain of the RAND SF-36 QoL Health Survey. The SF subscale consists of 2 items (Items 20 and 32) of the health survey. Item 20 is scored on a 5 point scale ranging from 1 ("Not at all") to 5 ("Extremely") and Item 32 is scored on a 5 point scale ranging from 1 ("All of the time") to 5 ("None of the time"). Item 20 is then inversely coded such that a precoded item value of 1 ("Not at all") is assigned a final item value of "5" and a precoded item value of 5 ("Extremely") is assigned a final item value of 1. Item 32 maintains the same final item value as precoded item value. This yields an overall scoring range of 2-10 for final value items. No additional transformation is done. For this measure a mean change from baseline for SF is calculated. A positive mean score is indicative of improved self-perception of physical functioning from baseline. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Effectiveness of Intervention to Change From Baseline to End of Follow-up, Scores on the Perceived Knowledge/Dialysis Self-Management Scale | Effectiveness of intervention to change kidney self-efficacy will be assessed using the "Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)" The PKDSMS is a unidimensional eight-item scale used to assess a participant's perceived ability to self-manage their condition. Participant responses are scored on a 1-5 Likert scale, with 1 representing "strongly disagree" to 5 representing "strongly agree." Total scoring ranges from 8-40 with higher scores indicating better perception of self-efficacy and self-management. For this study, mean change from baseline score is reported. A positive mean item score is indicative of better perception of self-efficacy and self-management; whereas, a negative mean item score is indicative of worsening perception of self-efficacy and self-management. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Efficacy of Intervention to Change From Baseline to End of Follow up, Scores on the CESD-R Scale in Participants Assigned to Peer Mentor Intervention as Compared to Participants Assigned to Usual Care | Scores on CESD-R (Center for Epidemiologic Studies Depression Scale Revised) in mentees assigned to intervention as compared to control mentees will be used to assess depressive symptoms. CESD. The 20 items in CESD-R scale measure symptoms of depression in nine different groups. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. Response values are as follows: Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 3 For this study, mean change from baseline score is reported. A positive mean score is indicative of improved depression symptoms; whereas, a negative mean score is indicative of worsening depression symptoms. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Social Support by Intervention Mentees as Compared to Usual Care Mentees | Perception of social support is measured using scores obtained from the "Multi-dimensional Scale of Perceived Social Support (MSPSS)." The MSPSS is a 12-item scale which measures perceived adequacy of social support from three sources: family, friends, and a significant other. The MSPSS is scored on a 7-point Likert scale (1-7) with 1 representing "very strongly disagree" and 7 representing "very strongly agree" for an overall possible range of 12-84. The total score can also be calculated as a mean score (dividing by 12). Higher scores are indicative of higher perceptions of adequate social support. For this study, change from baseline score of mean score is reported. A positive mean score is indicative of improved perceptions of social support; whereas, a negative mean score is indicative of decreased perceptions of social support. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Efficacy of Intervention to Change From Baseline Kidney Disease Self-management Behaviors in Intervention Mentees as Compared to Usual Care Mentees | Kidney disease self-management was determined by calculating the change in scores from baseline to end of follow up period using the "Kidney Disease Behavioral Index (KDBI)" survey tool. KDBI is a novel 16-item scale based on the Summary of Diabetes Self-Care Activities. It is used measure an individual's self-reported completion of specific self-care activities required for kidney disease self-management. The participant is asked to report how often they perform these activities over the past month and the 4-point response options range from 0 = "very slightly or not at all" to 3 = "quite a bit." Scores are summed over the 16 items for a possible scoring range of 0-48, with higher scores indicating a greater engagement in self-care behaviors for kidney disease management. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's completion of specific self-care activities required for kidney disease management. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time |
| Efficacy of Intervention to Change From Baseline Kidney Disease Coping Ability in Intervention Mentees as Compared to Usual Care Mentees | The Brief Kidney Cope (Brief "K" [Kidney]-COPE) survey was modified from the Brief COPE for use on study. The Brief K-COPE omits two scales of the full COPE, reduces others to two items per scale, and adds a scale. The Brief K-COPE is intended to foster a wider examination of coping in naturally occurring settings. The Brief K-COPE asks what the participant has done over the past month when a problem taking care of their kidney disease was encountered. The scale consists of 28-items (14 subscales composed of 2 items) scored from 0-3 where "0" = I didn't do this AT ALL, to "3" = I've been doing this A LOT, for a possible scoring range of 0-84. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's ability to cope with their kidney disease; whereas, a negative mean score is indicative a decreased ability to cope with their kidney disease. | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
| Vanderbilt University Medical Center |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Protocol Violation |
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| BG001 | Usual Care | This arm of patient participants will not get a telephone intervention by an assigned mentor. They will have 12-18 months of observational follow up by study team. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of hospitalizations in the one year prior to enrollment | Patient self-reported number of hospitalizations in the year prior to enrollment as recorded on baseline assessment. Mentors were not included in the trial. Patient participants or mentees were the subjects who were followed for the primary and secondary outcomes. Mentors implemented the intervention | Mean | Standard Deviation | Hospitalizations |
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| Number of ED visits in the year prior to enrollment. | Patient self-reported number of ED visits in the year prior to enrollment as recorded on baseline assessment. Mentors were not included in the trial. Patient participants or mentees were the subjects who were followed for the primary and secondary outcomes. Mentors implemented the intervention | Mean | Standard Deviation | ED visits |
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| OG001 | Usual Care | This arm of mentees will not get a telephone intervention by an assigned mentee |
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| Secondary | Change From Baseline to End of Follow-up in Average Number of Monthly Missed Dialysis Minutes | Average change in number of monthly minutes of dialysis missed by intervention participants as compared to usual care participants over the study period. | Posted | Mean | Standard Error | minutes per person per month | up to 18 months |
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| Secondary | Change From Baseline to End of Follow-up in Average Monthly Interdialytic Weight Gain in Patient Participants. | Change in monthly average fluid weight gain in-between dialysis treatments by intervention participants as compared to usual care participants over study period. | Per month rate of increase or decline in mean interdialytic weight gain | Posted | Mean | Standard Error | kg/month | up to 18 months |
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| Secondary | Change From Baseline in Average Monthly Serum Albumin Levels | Change in mean monthly albumin levels in intervention mentees as compared to control mentees over follow up period. | Posted | Mean | Standard Error | g/dL per month | up to 18 months |
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| Secondary | Efficacy of Intervention to Change Dialysis Knowledge in Mentees | Efficacy of intervention to change dialysis knowledge will be assessed based on the Score on Chronic Hemodialysis Knowledge Survey (CHeKs) in patient participants assigned to the peer-mentor intervention as compared patient participants assigned to usual care. Mean change in baseline scores are reported. The CHeKs survey consists of 23 multiple choice questions. Total score is determined by summing all correct items (blank items or items with more than one answer are considered incorrect). A positive mean percentage score is indicative of an improvement from baseline and demonstrated increased participant knowledge of hemodialysis care; whereas, a negative mean percentage score is indicative of decrease in demonstrated hemodialysis knowledge. | Posted | Mean | Standard Error | Percentage Change | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Efficacy of Intervention to Change Curriculum Specific Dialysis Knowledge in Patient Participants | Efficacy of intervention to change curriculum specific dialysis knowledge in patient participants was assessed based on a change from baseline in score on the "Chronic Hemodialysis Knowledge Survey (CHeKs) Plus" knowledge assessment, an assessment developed by the study team focused on topic covered in mentor training sessions, in patient-participants assigned to intervention as compared patient participants assigned to usual care. The CHeKs Plus survey is a multiple-choice training quiz which contains 8 questions. A mean change from baseline score was reported for the groups. A positive mean change demonstrated an improvement in specific hemodialysis knowledge; whereas, a decrease in score is indicative of decrease in specific hemodialysis knowledge. | Posted | Mean | Standard Error | Percentage Change | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Change From Baseline in General Health (GH) Perceptions Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in General Health will be assessed using the GH perceptions subscale domain of the RAND SF-36 QoL Health Survey. The GH subscale consists of 5 specific items (Items 1 and 33-36) of the health survey. Item 1 is scored on a 5 point scale ranging from 1 ("Excellent") to 5 ("Very Poor") and items 33-36 are scored on a 5 point scale ranging from 1 ("Definitely True") to 5 ("Definitely False"). Responses are then coded to the RAND scoring key for the respective items as follows: Items 1, 34, and 36 are inversely coded such that a precoded item value of 1 ("Excellent" or "Definitely True") is assigned a final item value of "5" and so forth. Items 33 and 35 maintain the same final item value as precoded item value. This yields an overall scoring range of 5-25 for final value items. No transformation was done. For this measure a mean change from baseline for GH is calculated. A positive mean score is indicative of improved self-perception of general health from baseline. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Change From Baseline in Physical Functioning (PF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in Physical Functioning (PF) will be assessed using the PF subscale domain of the RAND SF-36 QoL Health Survey. The PF subscale consists of 10 specific items (Items 3-12) of the health survey. These items are scored on a 3 point scale ranging from 1 ("Yes, limited a lot") to 3 ("No, not limited at all") The raw responses values and coded final item values are identical yielding an overall scoring range of 10-30 for final value items. No additional transformation is done. For this measure a mean change from baseline for PF is calculated. A positive mean score is associated with an improved self-perception of physical functioning from baseline. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Change From Baseline in Social Functioning (SF) Domain of V 2.0 of the RAND SF-36 Quality of Life (QOL) in Patient Participants Assigned to Peer-mentor Intervention as Compared to Patient Participants Assigned to Usual Care | Change from baseline in Social Functioning (SF) will be assessed using the SF subscale domain of the RAND SF-36 QoL Health Survey. The SF subscale consists of 2 items (Items 20 and 32) of the health survey. Item 20 is scored on a 5 point scale ranging from 1 ("Not at all") to 5 ("Extremely") and Item 32 is scored on a 5 point scale ranging from 1 ("All of the time") to 5 ("None of the time"). Item 20 is then inversely coded such that a precoded item value of 1 ("Not at all") is assigned a final item value of "5" and a precoded item value of 5 ("Extremely") is assigned a final item value of 1. Item 32 maintains the same final item value as precoded item value. This yields an overall scoring range of 2-10 for final value items. No additional transformation is done. For this measure a mean change from baseline for SF is calculated. A positive mean score is indicative of improved self-perception of physical functioning from baseline. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Effectiveness of Intervention to Change From Baseline to End of Follow-up, Scores on the Perceived Knowledge/Dialysis Self-Management Scale | Effectiveness of intervention to change kidney self-efficacy will be assessed using the "Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)" The PKDSMS is a unidimensional eight-item scale used to assess a participant's perceived ability to self-manage their condition. Participant responses are scored on a 1-5 Likert scale, with 1 representing "strongly disagree" to 5 representing "strongly agree." Total scoring ranges from 8-40 with higher scores indicating better perception of self-efficacy and self-management. For this study, mean change from baseline score is reported. A positive mean item score is indicative of better perception of self-efficacy and self-management; whereas, a negative mean item score is indicative of worsening perception of self-efficacy and self-management. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Efficacy of Intervention to Change From Baseline to End of Follow up, Scores on the CESD-R Scale in Participants Assigned to Peer Mentor Intervention as Compared to Participants Assigned to Usual Care | Scores on CESD-R (Center for Epidemiologic Studies Depression Scale Revised) in mentees assigned to intervention as compared to control mentees will be used to assess depressive symptoms. CESD. The 20 items in CESD-R scale measure symptoms of depression in nine different groups. The Total CESD-R Score is calculated as a sum of responses to all 20 questions. Response values are as follows: Not at all or less than one day = 0 1-2 days = 1 3-4 days = 2 5-7 days = 3 Nearly every day for 2 weeks = 3 For this study, mean change from baseline score is reported. A positive mean score is indicative of improved depression symptoms; whereas, a negative mean score is indicative of worsening depression symptoms. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Social Support by Intervention Mentees as Compared to Usual Care Mentees | Perception of social support is measured using scores obtained from the "Multi-dimensional Scale of Perceived Social Support (MSPSS)." The MSPSS is a 12-item scale which measures perceived adequacy of social support from three sources: family, friends, and a significant other. The MSPSS is scored on a 7-point Likert scale (1-7) with 1 representing "very strongly disagree" and 7 representing "very strongly agree" for an overall possible range of 12-84. The total score can also be calculated as a mean score (dividing by 12). Higher scores are indicative of higher perceptions of adequate social support. For this study, change from baseline score of mean score is reported. A positive mean score is indicative of improved perceptions of social support; whereas, a negative mean score is indicative of decreased perceptions of social support. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Secondary | Efficacy of Intervention to Change From Baseline Kidney Disease Self-management Behaviors in Intervention Mentees as Compared to Usual Care Mentees | Kidney disease self-management was determined by calculating the change in scores from baseline to end of follow up period using the "Kidney Disease Behavioral Index (KDBI)" survey tool. KDBI is a novel 16-item scale based on the Summary of Diabetes Self-Care Activities. It is used measure an individual's self-reported completion of specific self-care activities required for kidney disease self-management. The participant is asked to report how often they perform these activities over the past month and the 4-point response options range from 0 = "very slightly or not at all" to 3 = "quite a bit." Scores are summed over the 16 items for a possible scoring range of 0-48, with higher scores indicating a greater engagement in self-care behaviors for kidney disease management. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's completion of specific self-care activities required for kidney disease management. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time |
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| Secondary | Efficacy of Intervention to Change From Baseline Kidney Disease Coping Ability in Intervention Mentees as Compared to Usual Care Mentees | The Brief Kidney Cope (Brief "K" [Kidney]-COPE) survey was modified from the Brief COPE for use on study. The Brief K-COPE omits two scales of the full COPE, reduces others to two items per scale, and adds a scale. The Brief K-COPE is intended to foster a wider examination of coping in naturally occurring settings. The Brief K-COPE asks what the participant has done over the past month when a problem taking care of their kidney disease was encountered. The scale consists of 28-items (14 subscales composed of 2 items) scored from 0-3 where "0" = I didn't do this AT ALL, to "3" = I've been doing this A LOT, for a possible scoring range of 0-84. For this study, mean change from baseline score is reported. A positive mean score is indicative of improvement of an individual's ability to cope with their kidney disease; whereas, a negative mean score is indicative a decreased ability to cope with their kidney disease. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| Other Pre-specified | Efficacy of Intervention to Change From Baseline to End of Follow up, Perception of Dialysis Specific Social Support by Intervention Mentees as Compared to Usual Care Mentees | Change from baseline in Dialysis Specific Social Support was assessed using the Dialysis Specific Support Survey (developed by PI's). This survey was used to characterize the frequency of interactions between the participant and other dialysis patients. This survey consists of 6 items and the total score is the mean of the 6 items. Individual scores for the scale ranged from 1-5 where 1 = ("None of the time") and 5 = ("All of the time"), yielding a possible scoring range of 1-5. For this study, mean change from baseline score is reported. A positive mean score was reflective of more perceived dialysis social support; whereas, a negative mean score was reflective of less perceived dialysis social support. | Posted | Mean | Standard Error | score on a scale | Baseline and at end of 12-18 months, depending on whether patient enrolled before or after study amendment to shorten follow up time. |
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| 11 |
| 99 |
| 64 |
| 99 |
| 0 |
| 99 |
| EG001 | Usual Care | This arm of patient participants will not get a telephone intervention by an assigned mentor. They will have 12-18 months of observational follow up by study team. | 15 | 95 | 66 | 95 | 0 | 95 |
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