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

NCT02429115 | Completed Results

• 1 other identifier: CDR-1310-07055
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

peer mentoring; chronic kidney disease; quality of life; pcori; caregiver burden

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Slope of Change in Patient Activation Measure (PAM)

  Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.

Study Arms (3)

Face-to-face peer mentoring

EXPERIMENTAL

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

Other: Mentoring

Online peer mentoring

EXPERIMENTAL

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

Other: Mentoring

Control

NO INTERVENTION

Will not receive peer mentoring.

Interventions

Mentoring OTHER

Six months of peer-mentoring.

Face-to-face peer mentoring; Online peer mentoring

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• inability to provide consent;
• younger than 18 years of age;
• prisoners

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Kidney Foundation of Central Pennsylvania

Harrisburg, Pennsylvania, 17104, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Caregiver Burden

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Nasrollah Ghahramani
• Organization: Penn State College of Medicine - Penn State Health

nghahramani@pennstatehealth.psu.edu

7175318156

Study Officials

• Nasrollah Ghahramani, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: February 12, 2015
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-11

Locations

US (1)