Chronic Kidney Disease Clinical Trial
Official title:
Improving Patient Quality of Life and Caregiver Burden by a Peer-Led Mentoring Program for Patients With Chronic Kidney Disease and Their Caregivers
Verified date | November 2019 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 241 |
Est. completion date | June 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Kidney Foundation of Central Pennsylvania | Harrisburg | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. | |
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. |
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. | Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported. |
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