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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face peer mentoring | Experimental | Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. |
|
| Online peer mentoring | Experimental | Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. |
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| Control | No Intervention | Will not receive peer mentoring. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mentoring | Other | Six months of peer-mentoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
| 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. | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nasrollah Ghahramani, MD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kidney Foundation of Central Pennsylvania | Harrisburg | Pennsylvania | 17104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Online Peer Mentoring Patients | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. |
| FG002 | Control Patients | Will not receive peer mentoring. |
| FG003 | 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. |
| FG004 | Online Peer Mentoring Caregivers | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. |
| FG005 | Control Caregivers | Will not receive peer mentoring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Online Peer Mentoring Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | 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. | Patient participants. | Posted | Number | 95% Confidence Interval | Scores on a scale / Months | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
|
18 months
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nasrollah Ghahramani | Penn State College of Medicine - Penn State Health | 7175318156 | nghahramani@pennstatehealth.psu.edu |
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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 | Feb 11, 2015 | Jul 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
Will receive 6 months of online peer mentoring by a trained peer mentor.
Mentoring: Six months of peer-mentoring.
| BG002 | Control Patients | Will not receive peer mentoring. |
| BG003 | 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. |
| BG004 | Online Peer Mentoring Caregivers | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. |
| BG005 | Control Caregivers | Will not receive peer mentoring. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Ethnicity | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| At least some college | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Rural | Count of Participants | Participants |
|
Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. |
| OG001 | Online Peer Mentoring Patients | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. |
| OG002 | Control Patients | Will not receive peer mentoring. |
|
|
|
| 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. | Caregivers of patients with CKD | Posted | Number | 95% Confidence Interval | Scores on a scale / Months | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
|
|
|
|
| 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. | Patient participants | Posted | Number | 95% Confidence Interval | Scores on a scale / Months | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
|
|
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| 3 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Online Peer Mentoring Patients | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. | 4 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Control Patients | Will not receive peer mentoring. | 5 | 51 | 0 | 51 | 0 | 51 |
| EG003 | 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. | 1 | 29 | 0 | 29 | 0 | 29 |
| EG004 | Online Peer Mentoring Caregivers | Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring. | 1 | 29 | 0 | 29 | 0 | 29 |
| EG005 | Control Caregivers | Will not receive peer mentoring. | 1 | 28 | 0 | 28 | 0 | 28 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |