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

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ClinicalTrials.gov Identifier: NCT02429115
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Nasrollah Ghahramani, Milton S. Hershey Medical Center

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Mentoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 12, 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Quality of Life Survey Questionnaire [ Time Frame: Change in Quality of Life score from baseline at 12 months and 18 months ]

Secondary Outcome Measures :
  1. Patient Activation Measure [ Time Frame: Change in Patient Acitvation Measure from baseline at 12 months and 18 months ]
  2. Zarit Caregiver Burden Interview [ Time Frame: Change in Zarit Caregiver Burden Score from baseline at 12 months and 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429115


Locations
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United States, Pennsylvania
Kidney Foundation of Central Pennsylvania
Harrisburg, Pennsylvania, United States, 17104
Sponsors and Collaborators
Milton S. Hershey Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Nasrollah Ghahramani, MD Penn State College of Medicine

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Responsible Party: Nasrollah Ghahramani, Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02429115     History of Changes
Other Study ID Numbers: CDR-1310-07055
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Nasrollah Ghahramani, Milton S. Hershey Medical Center:
peer mentoring
chronic kidney disease
quality of life
pcori
caregiver burden

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency