Chronic Kidney Disease
Conditions
Keywords
peer mentoring, chronic kidney disease, quality of life, pcori, caregiver burden
Brief summary
Receiving supportive mentoring from well-adjusted individuals who share similar experiences has had a positive influence on adjustment with some chronic diseases. In this study, patients with advanced chronic kidney disease and caregivers of such patients will be randomly assigned to one of three groups: (1) face-to-face PFPP-individuals will receive six months of PFPP peer-mentoring, along with an informational text; (2) online PFPP-individuals will receive six months of online peer-mentoring modeled after the PFPP program, along with an informational text; and (3) information-only control group-individuals will receive the text of the material provided to the other two groups. The study team's decision to include an online version is based on suggestions by previous participants who indicated that this would be convenient for individuals for whom distance and geographic location are major considerations of participation. The investigators expect that both face-to-face and online peer-mentorship programs will result in improved quality of life among patients with advanced kidney disease and decreased feeling of burden among caregivers of these patients. The investigators also expect that mentorship will lead to improved engagement of patients in their own care.
Detailed description
Chronic kidney disease is very common in the United States, and throughout the world. An increasing number of individuals are diagnosed with late stages of chronic kidney disease, which require treatment with either dialysis or kidney transplant. The number of individuals currently requiring such treatment in the United States is greater than 600,000. Patients with advanced kidney disease and their family members face many challenges in dealing with the disease and the decisions that relate to choice of treatment. Quite frequently, patients and their family members are faced with the need to decide on a treatment option without full awareness of all the options. In such cases, they might make choices with which they will not be satisfied. Poor satisfaction with treatment choice is likely to result in poor quality of life for the patients and increased sense of burden for the caregiver. Receiving supportive mentoring from well-adjusted individuals who share similar experiences has had a positive influence on adjustment with some chronic diseases. Since 2004, the Kidney Foundation of Central Pennsylvania has conducted a program to formally train patients with kidney disease and their caregivers to become mentors for patients or caregivers who feel they might benefit from such mentoring. The program, the Patient and Family Partner Program (PFPP), was envisioned and designed by a patient with chronic kidney disease and has trained approximately 130 mentors. In this study, patients with advanced chronic kidney disease and caregivers of such patients will be randomly assigned to one of three groups: (1) face-to-face PFPP-individuals will receive six months of PFPP peer-mentoring, along with an informational text; (2) online PFPP-individuals will receive six months of online peer-mentoring modeled after the PFPP program, along with an informational text; and (3) information-only control group-individuals will receive the text of the material provided to the other two groups. The study team's decision to include an online version is based on suggestions by previous participants who indicated that this would be convenient for individuals for whom distance and geographic location are major considerations of participation. The investigators expect that both face-to-face and online peer-mentorship programs will result in improved quality of life among patients with advanced kidney disease and decreased feeling of burden among caregivers of these patients. The investigators also expect that mentorship will lead to improved engagement of patients in their own care.
Interventions
OTHERMentoring
Six months of peer-mentoring.
Sponsors
Patient-Centered Outcomes Research Institute
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with stage 4 or 5 CKD by a physician / or caregiver to a patient with stage 4 or 5 CKD; * at least 18 years of age; * able to read and write in English at the 8th grade level; * access to computer with internet and email capability
Exclusion criteria
* inability to provide consent; * younger than 18 years of age; * prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope of Change in Kidney Disease Quality of Life-36 Score | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. | The Kidney Disease Quality of Life-36 (KDQOL-36) score is the primary outcome measure. The KDQOL-36 contains 5 subscales: the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The range for the sore of each domain is 0-100. Higher scores represent improved Quality of Life. Change in the scores of components of the KDQOL is the outcome variable of interest. We computed the slopes (rates of change in KDQOL subscales from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test. |
| Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. | The Zarit caregiver Burden Interview (ZBI) score is the primary outcome measure. The score ranges between 0 and 88. Higher scores represent increased caregiver burden (worse outcome); smaller numbers indicate less caregiver burden (better outcome). Change in the ZBI score is the outcome variable of interest. We computed the slopes (rates of change in ZBI from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slope of Change in Patient Activation Measure (PAM) | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. | The Patient Activation Measure (PAM) is the secondary outcome measure. The score ranges between 0-100. Higher scores represent improved patient activation and lower numbers indicate less patient activation. Change in the PAM is the outcome variable of interest. We computed the slopes ( rate of change in the PAM score from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different among the study groups using t-test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Face-to-face Peer Mentoring Patients Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Mentoring: Six months of peer-mentoring. | 52 |
| Online Peer Mentoring Patients Will receive 6 months of online peer mentoring by a trained peer mentor.
Mentoring: Six months of peer-mentoring. | 52 |
| Control Patients Will not receive peer mentoring. | 51 |
| Face-to-face Peer Mentoring Caregivers Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Mentoring: Six months of peer-mentoring. | 29 |
| Online Peer Mentoring Caregivers Will receive 6 months of online peer mentoring by a trained peer mentor.
Mentoring: Six months of peer-mentoring. | 29 |
| Control Caregivers Will not receive peer mentoring. | 28 |
| Total | 241 |
Baseline characteristics
| Characteristic | Face-to-face Peer Mentoring Patients | Total | Control Caregivers | Online Peer Mentoring Caregivers | Face-to-face Peer Mentoring Caregivers | Control Patients | Online Peer Mentoring Patients |
|---|---|---|---|---|---|---|---|
| Age, Customized 47< Age ≤ 54 | 14 Participants | 54 Participants | 6 Participants | 5 Participants | 7 Participants | 12 Participants | 10 Participants |
| Age, Customized 54 <Age ≤ 62 | 12 Participants | 59 Participants | 5 Participants | 6 Participants | 9 Participants | 12 Participants | 15 Participants |
| Age, Customized 62 < Age | 15 Participants | 58 Participants | 9 Participants | 7 Participants | 6 Participants | 12 Participants | 9 Participants |
| Age, Customized Age ≤ 47 | 11 Participants | 70 Participants | 8 Participants | 11 Participants | 7 Participants | 15 Participants | 18 Participants |
| At least some college No | 30 Participants | 132 Participants | 19 Participants | 17 Participants | 18 Participants | 26 Participants | 22 Participants |
| At least some college Yes | 22 Participants | 109 Participants | 9 Participants | 12 Participants | 11 Participants | 25 Participants | 30 Participants |
| Employed Employed | 13 Participants | 82 Participants | 12 Participants | 13 Participants | 11 Participants | 16 Participants | 17 Participants |
| Employed Not Employed | 39 Participants | 159 Participants | 16 Participants | 16 Participants | 18 Participants | 35 Participants | 35 Participants |
| Ethnicity Hispanic | 5 Participants | 25 Participants | 2 Participants | 4 Participants | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity Non-Hispanic | 47 Participants | 216 Participants | 26 Participants | 25 Participants | 27 Participants | 44 Participants | 47 Participants |
| Marital Status Married | 16 Participants | 116 Participants | 18 Participants | 20 Participants | 20 Participants | 21 Participants | 21 Participants |
| Marital Status Not married | 36 Participants | 125 Participants | 10 Participants | 9 Participants | 9 Participants | 30 Participants | 31 Participants |
| Race/Ethnicity, Customized Non-white | 28 Participants | 127 Participants | 14 Participants | 16 Participants | 16 Participants | 27 Participants | 26 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 114 Participants | 14 Participants | 13 Participants | 13 Participants | 24 Participants | 26 Participants |
| Rural Rural | 4 Participants | 45 Participants | 8 Participants | 11 Participants | 6 Participants | 9 Participants | 7 Participants |
| Rural Urban | 48 Participants | 196 Participants | 20 Participants | 18 Participants | 23 Participants | 42 Participants | 45 Participants |
| Sex/Gender, Customized Female | 25 Participants | 122 Participants | 17 Participants | 20 Participants | 18 Participants | 21 Participants | 21 Participants |
| Sex/Gender, Customized Male | 27 Participants | 119 Participants | 11 Participants | 9 Participants | 11 Participants | 30 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 52 | 4 / 52 | 5 / 51 | 1 / 29 | 1 / 29 | 1 / 28 |
| other Total, other adverse events | 0 / 52 | 0 / 52 | 0 / 51 | 0 / 29 | 0 / 29 | 0 / 28 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 | 0 / 51 | 0 / 29 | 0 / 29 | 0 / 28 |
Outcome results
Primary
Slope of Change in Kidney Disease Quality of Life-36 Score
The Kidney Disease Quality of Life-36 (KDQOL-36) score is the primary outcome measure. The KDQOL-36 contains 5 subscales: the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The range for the sore of each domain is 0-100. Higher scores represent improved Quality of Life. Change in the scores of components of the KDQOL is the outcome variable of interest. We computed the slopes (rates of change in KDQOL subscales from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test.
Time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.
Population: Patient participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Face-to-face Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Mental Composite Score | 1.43 Scores on a scale / Months |
| Face-to-face Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Effects of Kidney Disease | 2.21 Scores on a scale / Months |
| Face-to-face Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Burden of Kidney Disease | 3.00 Scores on a scale / Months |
| Face-to-face Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Physical Composite | 0.64 Scores on a scale / Months |
| Face-to-face Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Symptoms/Problems of Kidney Disease | 3.41 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Burden of Kidney Disease | 5.44 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Symptoms/Problems of Kidney Disease | 6.00 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Physical Composite | 2.50 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Mental Composite Score | 3.46 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Effects of Kidney Disease | 4.13 Scores on a scale / Months |
| Control Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Effects of Kidney Disease | -0.50 Scores on a scale / Months |
| Control Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Burden of Kidney Disease | -0.99 Scores on a scale / Months |
| Control Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Mental Composite Score | 1.13 Scores on a scale / Months |
| Control Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Symptoms/Problems of Kidney Disease | -2.71 Scores on a scale / Months |
| Control Patients | Slope of Change in Kidney Disease Quality of Life-36 Score | Short Form-12 Physical Composite | -0.70 Scores on a scale / Months |
p-value: <0.05ANOVA
Primary
Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score
The Zarit caregiver Burden Interview (ZBI) score is the primary outcome measure. The score ranges between 0 and 88. Higher scores represent increased caregiver burden (worse outcome); smaller numbers indicate less caregiver burden (better outcome). Change in the ZBI score is the outcome variable of interest. We computed the slopes (rates of change in ZBI from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test.
Time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.
Population: Caregivers of patients with CKD
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Peer Mentoring Patients | Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score | -2.49 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score | -3.44 Scores on a scale / Months |
| Control Patients | Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score | -1.26 Scores on a scale / Months |
p-value: <0.05ANOVA
Secondary
Slope of Change in Patient Activation Measure (PAM)
The Patient Activation Measure (PAM) is the secondary outcome measure. The score ranges between 0-100. Higher scores represent improved patient activation and lower numbers indicate less patient activation. Change in the PAM is the outcome variable of interest. We computed the slopes ( rate of change in the PAM score from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different among the study groups using t-test.
Time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.
Population: Patient participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Peer Mentoring Patients | Slope of Change in Patient Activation Measure (PAM) | 0.95 Scores on a scale / Months |
| Online Peer Mentoring Patients | Slope of Change in Patient Activation Measure (PAM) | 5.66 Scores on a scale / Months |
| Control Patients | Slope of Change in Patient Activation Measure (PAM) | 0.02 Scores on a scale / Months |
p-value: <0.05ANOVA