ESRD
Conditions
Keywords
Patient-Centered Care, Medical Home
Brief summary
This study will implement and evaluate a patient-centered medical home for kidney disease (PCMH-KD) compared to the usual model of dialysis care. Patients will be observed for an initial baseline period under the usual care model and then the usual dialysis care team will be expanded to include a pharmacist, community health worker, nurse coordinator and a primary care doctor. Outcomes of interest will be assessed at baseline and then every 6 months after the PCMH-KD intervention commences.
Detailed description
Patients with end-stage renal disease (ESRD), have unique and complex care needs associated with renal disease and common comorbidities (e.g., diabetes, hypertension), and under the current care model, receive fragmented care from multiple providers at multiple locations. ESRD patients typically spend three to five hours undergoing dialysis three days a week. Scheduling and traveling to other appointments are difficult to manage, increase patient and caregiver burden, and reduce patients' quality of life. These challenges keep many ESRD patients from receiving care for other conditions outside of the dialysis setting, resulting in higher rates of complications, and emergent healthcare use. The patient-centered medical home (PCMH) model has been proposed as a solution to patients with complex needs such as those with ESRD. The purpose of this project is to compare a PCMH model of care with the usual care of ESRD patients and their caregivers. We propose to enhance the usual care team for ESRD patients by providing a primary care doctor in the context of regularly scheduled dialysis sessions and by adding community health workers to help support patients and their caregivers. Patient and family stakeholders and care team members will assist in the design and refinement of the PCMH model. We plan to implement this model at the University of Illinois Hospital and Health Sciences System (UIHS) dialysis center and a local Fresenius Medical Care dialysis center. Patients receiving dialysis at participating centers will receive an initial comprehensive care visit followed by ongoing care from a multispecialty provider team during the patients' regularly scheduled dialysis visits. Each patient's care team will include a kidney doctor, a primary care doctor, a nurse coordinator, a dialysis nurse, a dietician, a pharmacist, a social worker, and a community health worker. The primary care doctor will be available in the dialysis clinic to provide general and preventive care to the patient before or after dialysis sessions. This doctor would also coordinate care with other specialists/clinicians on the patient's care team. The trained, bilingual (English/Spanish) community health worker will assist with making and rescheduling appointments, obtaining transportation, and reinforcing education components. We expect that this approach will increase patient access to care for other conditions and will increase care coordination and communication among members of the patient's care team. These improvements could potentially increase the likelihood of preventing complications or identifying problems earlier and allow for a more successful treatment. We expect that this enhanced care team will reduce emergency room visits and hospitalizations for dialysis patients. In addition, we anticipate that the addition of community health workers to the clinical team will help support and educate patients and their caregivers and as a result, patient quality of life will improve and caregiver burden may be reduced.
Interventions
OTHERPatient-Centered Medical Home for Kidney Disease (PCMH-KD)
A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team.
Sponsors
Patient-Centered Outcomes Research Institute
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current patient receiving hemodialysis at two participating dialysis centers who are able to provide informed consent
Exclusion criteria
* Not a patient at one of the two participating dialysis centers or not able to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Baseline (0) to 18 months | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. |
| Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Baseline (0) to 18 months | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates. |
| Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Baseline (0) to 18 months | Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. |
Countries
United States
Participant flow
Recruitment details
The PCMH-KD model was implemented at two dialysis centers, an academic dialysis center and a private dialysis center. Patients were recruited, screened and enrolled at both sites. After consenting, study participants completed a baseline survey and on a rolling basis three follow-up interviews at six, twelve, and eighteen months.
Pre-assignment details
Clinical data (six months prior to enrollment date) was collected from the electronic medical record for all participants to compare the usual care for enrolled patients with the care received during the PCMH-KD intervention.
Participants by arm
| Arm | Count |
|---|---|
| PCMH-KD Dialysis Care Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Intervention Period 1: 0-6 Months | Death | 7 |
| Intervention Period 1: 0-6 Months | No longer patient at study site | 5 |
| Intervention Period 1: 0-6 Months | Received transplant | 3 |
| Intervention Period 1: 0-6 Months | Withdrawal by Subject | 1 |
| Intervention Period 2: 6-12 Months | Death | 5 |
| Intervention Period 2: 6-12 Months | Intervention ended before follow-up | 17 |
| Intervention Period 2: 6-12 Months | No longer patient at study site | 7 |
| Intervention Period 2: 6-12 Months | Received transplant | 1 |
| Intervention Period 2: 6-12 Months | Withdrawal by Subject | 2 |
| Intervention Period 3: 12-18 Months | Death | 3 |
| Intervention Period 3: 12-18 Months | Intervention ended before follow-up | 16 |
| Intervention Period 3: 12-18 Months | No longer patient at study site | 2 |
| Intervention Period 3: 12-18 Months | Received transplant | 2 |
| Intervention Period 3: 12-18 Months | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PCMH-KD Dialysis Care |
|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 15 |
| Children under 18 yr in household 1 child under 18 yr in household | 22 Participants |
| Children under 18 yr in household ≥ 2 children under 18 yr in household | 21 Participants |
| Children under 18 yr in household No children under 18 yr in household | 132 Participants |
| Chronic Hemodialysis Knowledge Survey (CHeKS) | 51.8 units on scale STANDARD_DEVIATION 15.7 |
| Comorbidities 1 | 55 Participants |
| Comorbidities 2 to 3 | 91 Participants |
| Comorbidities 4 to 7 | 14 Participants |
| Comorbidities None | 15 Participants |
| Dialysis History Years at current center | 3.3 years STANDARD_DEVIATION 4.4 |
| Dialysis History Years on dialysis | 4.4 years STANDARD_DEVIATION 5.2 |
| Education Bachelor's degree | 13 Participants |
| Education HS graduate/GED | 100 Participants |
| Education Not HS graduate | 62 Participants |
| Employment Full-time/Self-employed | 16 Participants |
| Employment Not employed | 143 Participants |
| Employment Part-time | 15 Participants |
| Health Literacy Adequate (3-8) | 106 Participants |
| Health Literacy Inadequate/marginal (9-15) | 69 Participants |
| Income $20,000-$39,999 | 30 Participants |
| Income ≥ $40,000 | 22 Participants |
| Income Less than $20,000 | 108 Participants |
| Income Refused | 15 Participants |
| Insurance (any type) No | 17 Participants |
| Insurance (any type) Yes | 158 Participants |
| Interview language English | 117 Participants |
| Interview language Spanish | 58 Participants |
| Marital status Married/Living with a partner | 62 Participants |
| Marital status Separated, divorced | 21 Participants |
| Marital status Single, never married | 70 Participants |
| Marital status Widowed | 22 Participants |
| Primary Care Assessment Survey (PCAS) Communication | 74.3 units on a scale STANDARD_DEVIATION 18.8 |
| Primary Care Assessment Survey (PCAS) Comprehensive Knowledge | 65.4 units on a scale STANDARD_DEVIATION 21.3 |
| Primary Care Assessment Survey (PCAS) Integration of Care | 67.8 units on a scale STANDARD_DEVIATION 22.2 |
| Primary Care Assessment Survey (PCAS) Interpersonal Treatment | 75.2 units on a scale STANDARD_DEVIATION 17.3 |
| Primary Care Assessment Survey (PCAS) Longitudinal Continuity | 52.9 units on a scale STANDARD_DEVIATION 37.2 |
| Primary language Both equally | 14 Participants |
| Primary language English | 107 Participants |
| Primary language Spanish/other | 54 Participants |
| Primary transportation to clinic Car (drive or ride) | 87 Participants |
| Primary transportation to clinic Medicar (Medicaid) | 42 Participants |
| Primary transportation to clinic Other | 15 Participants |
| Primary transportation to clinic PACE paratransit/door to door | 17 Participants |
| Primary transportation to clinic Transit (L train or bus) | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African-American | 86 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/other | 89 Participants |
| Race/ethnicity*language African-American | 86 Participants |
| Race/ethnicity*language Hispanic/other, English interview | 31 Participants |
| Race/ethnicity*language Hispanic, Spanish interview | 58 Participants |
| Region of Enrollment United States | 175 participants |
| Regular doctor (Primary Care Physician) Has regular personal doctor | 104 Participants |
| Regular doctor (Primary Care Physician) No regular personal doctor | 71 Participants |
| Self-Efficacy for Managing Chronic Disease (SEMCD) | 7.2 units on scale STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 78 Participants |
| Sex: Female, Male Male | 97 Participants |
| Stressful life events (e.g. hospitalization, loss of employment or family member) in past 6 months No | 96 Participants |
| Stressful life events (e.g. hospitalization, loss of employment or family member) in past 6 months Yes | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 175 |
| serious Total, serious adverse events | 0 / 175 |
Outcome results
Primary
Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models
Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.
Time frame: Baseline (0) to 18 months
Population: All records with data for the KDQOL scale score (dependent variable) and covariates were included in the analysis. Two participants were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. The previous table (adjusted means) shows the number of records with complete data for each visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Symptoms/Problems of Kidney Disease | 2.6 units on a scale | Standard Error 1.1 |
| Baseline | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Mental Component Summary (MCS) | 1.2 units on a scale | Standard Error 1 |
| Baseline | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Effects of Kidney Disease | 4.3 units on a scale | Standard Error 1.5 |
| Baseline | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Burden of Kidney Disease | 2.6 units on a scale | Standard Error 2 |
| Baseline | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Physical Component Summary (PCS) | 2.6 units on a scale | Standard Error 0.8 |
| 6 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Burden of Kidney Disease | 0.6 units on a scale | Standard Error 2 |
| 6 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Symptoms/Problems of Kidney Disease | -0.4 units on a scale | Standard Error 1.2 |
| 6 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Effects of Kidney Disease | 2.4 units on a scale | Standard Error 1.6 |
| 6 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Mental Component Summary (MCS) | 1.3 units on a scale | Standard Error 1 |
| 6 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Physical Component Summary (PCS) | -2.3 units on a scale | Standard Error 0.9 |
| 12 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Burden of Kidney Disease | 0.6 units on a scale | Standard Error 2.2 |
| 12 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Physical Component Summary (PCS) | 0.7 units on a scale | Standard Error 1 |
| 12 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Mental Component Summary (MCS) | 0.3 units on a scale | Standard Error 1.1 |
| 12 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Symptoms/Problems of Kidney Disease | -2.9 units on a scale | Standard Error 1.3 |
| 12 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Effects of Kidney Disease | -2.8 units on a scale | Standard Error 1.8 |
| 18 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Symptoms/Problems of Kidney Disease | -0.7 units on a scale | Standard Error 1.3 |
| 18 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Mental Component Summary (MCS) | 2.8 units on a scale | Standard Error 1.1 |
| 18 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Physical Component Summary (PCS) | 1.0 units on a scale | Standard Error 1 |
| 18 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Burden of Kidney Disease | 3.8 units on a scale | Standard Error 2.1 |
| 18 Months | Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models | Effects of Kidney Disease | 3.9 units on a scale | Standard Error 1.7 |
Comparison: PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.002Mixed Models Analysis
Comparison: MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.23Mixed Models Analysis
Comparison: Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.18Mixed Models Analysis
Comparison: Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.02Mixed Models Analysis
Comparison: Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.004Mixed Models Analysis
Comparison: PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.01Mixed Models Analysis
Comparison: MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.21Mixed Models Analysis
Comparison: Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.77Mixed Models Analysis
Comparison: Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.77Mixed Models Analysis
Comparison: Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.14Mixed Models Analysis
Comparison: PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.45Mixed Models Analysis
Comparison: MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.79Mixed Models Analysis
Comparison: Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.77Mixed Models Analysis
Comparison: Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.03Mixed Models Analysis
Comparison: Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.12Mixed Models Analysis
Comparison: PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.29Mixed Models Analysis
Comparison: MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.01Mixed Models Analysis
Comparison: Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.08Mixed Models Analysis
Comparison: Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.61Mixed Models Analysis
Comparison: Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.p-value: 0.02Mixed Models Analysis
Primary
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted
Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100. Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates.
Time frame: Baseline (0) to 18 months
Population: Ns shown in the table are the number of records at each visit with data for the KDQOL scale score and all covariates. All available records were used to estimate the adjusted means. For all scales, N=173 participants; 2 were excluded due to missing data for covariates: dialysis vintage and PCP at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Physical Component Summary (PCS) | 35.7 units on a scale | Standard Error 0.9 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Symptoms/Problems of Kidney Disease | 77.1 units on a scale | Standard Error 1.3 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Mental Component Summary (MCS) | 48.9 units on a scale | Standard Error 0.9 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Effects of Kidney Disease | 73.0 units on a scale | Standard Error 1.8 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Burden of Kidney Disease | 45.8 units on a scale | Standard Error 2.4 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Physical Component Summary (PCS) | 38.3 units on a scale | Standard Error 1 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Effects of Kidney Disease | 77.2 units on a scale | Standard Error 1.9 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Mental Component Summary (MCS) | 50.1 units on a scale | Standard Error 1 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Symptoms/Problems of Kidney Disease | 79.6 units on a scale | Standard Error 1.4 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Burden of Kidney Disease | 48.4 units on a scale | Standard Error 2.5 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Burden of Kidney Disease | 49.0 units on a scale | Standard Error 2.5 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Symptoms/Problems of Kidney Disease | 79.3 units on a scale | Standard Error 1.5 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Effects of Kidney Disease | 79.6 units on a scale | Standard Error 2 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Physical Component Summary (PCS) | 36.0 units on a scale | Standard Error 1 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Mental Component Summary (MCS) | 51.4 units on a scale | Standard Error 1 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Burden of Kidney Disease | 49.7 units on a scale | Standard Error 2.7 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Mental Component Summary (MCS) | 51.7 units on a scale | Standard Error 1.1 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Effects of Kidney Disease | 76.9 units on a scale | Standard Error 2.1 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Symptoms/Problems of Kidney Disease | 76.4 units on a scale | Standard Error 1.5 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted | Physical Component Summary (PCS) | 36.7 units on a scale | Standard Error 1.1 |
Primary
Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted
Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.
Time frame: Baseline (0) to 18 months
Population: Overall number of participants analyzed are the number who completed the KDQOL at each visit. They differ slightly from the number of participants in the flow chart due to missing KDQOL data. Ns are slightly lower for some scale scores due to missing items (see below).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Symptoms/Problems of Kidney Disease | 76.5 units on a scale | Standard Deviation 15.9 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Mental Component Summary (MCS) | 49.2 units on a scale | Standard Deviation 10.6 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Effects of Kidney Disease | 72.3 units on a scale | Standard Deviation 20.6 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Burden of Kidney Disease | 46.5 units on a scale | Standard Deviation 27.1 |
| Baseline | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Physical Component Summary (PCS) | 35.5 units on a scale | Standard Deviation 10.2 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Burden of Kidney Disease | 48.8 units on a scale | Standard Deviation 26.7 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Symptoms/Problems of Kidney Disease | 79.9 units on a scale | Standard Deviation 14.2 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Effects of Kidney Disease | 76.3 units on a scale | Standard Deviation 20.6 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Mental Component Summary (MCS) | 50.4 units on a scale | Standard Deviation 11.3 |
| 6 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Physical Component Summary (PCS) | 38.4 units on a scale | Standard Deviation 11.4 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Burden of Kidney Disease | 49.6 units on a scale | Standard Deviation 23.3 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Physical Component Summary (PCS) | 36.3 units on a scale | Standard Deviation 11.2 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Mental Component Summary (MCS) | 51.8 units on a scale | Standard Deviation 10.2 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Symptoms/Problems of Kidney Disease | 79.7 units on a scale | Standard Deviation 13.6 |
| 12 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Effects of Kidney Disease | 78.3 units on a scale | Standard Deviation 18.9 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Symptoms/Problems of Kidney Disease | 76.8 units on a scale | Standard Deviation 16.7 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Mental Component Summary (MCS) | 52.4 units on a scale | Standard Deviation 9.7 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Physical Component Summary (PCS) | 36.8 units on a scale | Standard Deviation 11.2 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Burden of Kidney Disease | 51.2 units on a scale | Standard Deviation 30.3 |
| 18 Months | Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted | Effects of Kidney Disease | 76.1 units on a scale | Standard Deviation 20.1 |