Peer-mentoring, Quality of Life and Caregiver Burden in Patients With Chronic Kidney Disease and Their Caregivers

November 21, 2019 updated by: Nasrollah Ghahramani, Milton S. Hershey Medical Center

Improving Patient Quality of Life and Caregiver Burden by a Peer-Led Mentoring Program for Patients With Chronic Kidney Disease and Their Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Kidney Foundation of Central Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Face-to-face peer mentoring
Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Other: Mentoring
Six months of peer-mentoring.
Experimental: Online peer mentoring
Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Other: Mentoring
Six months of peer-mentoring.
No Intervention: Control
Will not receive peer mentoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Slope of Change in Kidney Disease Quality of Life-36 Score
Time Frame: 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.
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
Time Frame: 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.
Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Slope of Change in Patient Activation Measure (PAM)
Time Frame: 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.
Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Nasrollah Ghahramani, MD, Penn State College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2015

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR-1310-07055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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