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

NCT ID: NCT02429115

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-12

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Keywords

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peer mentoring chronic kidney disease quality of life pcori caregiver burden

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Face-to-face peer mentoring

Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.

Group Type EXPERIMENTAL

Mentoring

Intervention Type OTHER

Six months of peer-mentoring.

Online peer mentoring

Will receive 6 months of face-to-face peer mentoring by a trained peer mentor.

Group Type EXPERIMENTAL

Mentoring

Intervention Type OTHER

Six months of peer-mentoring.

Control

Will not receive peer mentoring.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mentoring

Six months of peer-mentoring.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nasrollah Ghahramani

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nasrollah Ghahramani, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Kidney Foundation of Central Pennsylvania

Harrisburg, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CDR-1310-07055

Identifier Type: -

Identifier Source: org_study_id