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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02429115
• Collaborator: Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 241
• Location: 1
• Arms: 3
• Actual Duration (Months): 40.5
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 12, 2015
• Actual Primary Completion Date: Apr 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Slope of Change in Kidney Disease Quality of Life-36 Score [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.

2. Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score [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.

Secondary Outcome Measures

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.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kidney Foundation of Central Pennsylvania	Harrisburg	Pennsylvania	United States	17104

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 11, 2015

More Information

Publications

None provided.

• Responsible Party: Nasrollah Ghahramani, Professor of Medicine, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02429115
• Other Study ID Numbers: CDR-1310-07055
• First Posted: Apr 29, 2015
• Last Update Posted: Dec 13, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Nasrollah Ghahramani, Professor of Medicine, Milton S. Hershey Medical Center: peer mentoring; chronic kidney disease; quality of life; pcori; caregiver burden
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Caregiver Burden

Study Results

Participant Flow

Arm/Group Title	Face-to-face Peer Mentoring Patients	Online Peer Mentoring Patients	Control Patients	Face-to-face Peer Mentoring Caregivers	Online Peer Mentoring Caregivers	Control Caregivers
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.
Period Title: Overall Study
STARTED	52	52	51	29	29	28
COMPLETED	40	42	35	21	22	27
NOT COMPLETED	12	10	16	8	7	1

Baseline Characteristics

Arm/Group Title	Face-to-face Peer Mentoring Patients	Online Peer Mentoring Patients	Control Patients	Face-to-face Peer Mentoring Caregivers	Online Peer Mentoring Caregivers	Control Caregivers	Total
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.	Total of all reporting groups
Overall Participants	52	52	51	29	29	28	241
Age, Customized (Count of Participants)
Age ≤ 47	11 21.2%	18 34.6%	15 29.4%	7 24.1%	11 37.9%	8 28.6%	70 29%
47< Age ≤ 54	14 26.9%	10 19.2%	12 23.5%	7 24.1%	5 17.2%	6 21.4%	54 22.4%
54 <Age ≤ 62	12 23.1%	15 28.8%	12 23.5%	9 31%	6 20.7%	5 17.9%	59 24.5%
62 < Age	15 28.8%	9 17.3%	12 23.5%	6 20.7%	7 24.1%	9 32.1%	58 24.1%
Sex/Gender, Customized (Count of Participants)
Male	27 51.9%	31 59.6%	30 58.8%	11 37.9%	9 31%	11 39.3%	119 49.4%
Female	25 48.1%	21 40.4%	21 41.2%	18 62.1%	20 69%	17 60.7%	122 50.6%
Race/Ethnicity, Customized (Count of Participants)
White	24 46.2%	26 50%	24 47.1%	13 44.8%	13 44.8%	14 50%	114 47.3%
Non-white	28 53.8%	26 50%	27 52.9%	16 55.2%	16 55.2%	14 50%	127 52.7%
Ethnicity (Count of Participants)
Hispanic	5 9.6%	5 9.6%	7 13.7%	2 6.9%	4 13.8%	2 7.1%	25 10.4%
Non-Hispanic	47 90.4%	47 90.4%	44 86.3%	27 93.1%	25 86.2%	26 92.9%	216 89.6%
Marital Status (Count of Participants)
Married	16 30.8%	21 40.4%	21 41.2%	20 69%	20 69%	18 64.3%	116 48.1%
Not married	36 69.2%	31 59.6%	30 58.8%	9 31%	9 31%	10 35.7%	125 51.9%
At least some college (Count of Participants)
Yes	22 42.3%	30 57.7%	25 49%	11 37.9%	12 41.4%	9 32.1%	109 45.2%
No	30 57.7%	22 42.3%	26 51%	18 62.1%	17 58.6%	19 67.9%	132 54.8%
Employed (Count of Participants)
Employed	13 25%	17 32.7%	16 31.4%	11 37.9%	13 44.8%	12 42.9%	82 34%
Not Employed	39 75%	35 67.3%	35 68.6%	18 62.1%	16 55.2%	16 57.1%	159 66%
Rural (Count of Participants)
Rural	4 7.7%	7 13.5%	9 17.6%	6 20.7%	11 37.9%	8 28.6%	45 18.7%
Urban	48 92.3%	45 86.5%	42 82.4%	23 79.3%	18 62.1%	20 71.4%	196 81.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Patient participants.

Arm/Group Title	Face-to-face Peer Mentoring Patients	Online Peer Mentoring Patients	Control Patients
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.
Measure Participants	52	52	51
Effects of Kidney Disease	2.21	4.13	-0.50
Burden of Kidney Disease	3.00	5.44	-0.99
Short Form-12 Physical Composite	0.64	2.50	-0.70
Short Form-12 Mental Composite Score	1.43	3.46	1.13
Symptoms/Problems of Kidney Disease	3.41	6.00	-2.71

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Face-to-face Peer Mentoring Patients, Online Peer Mentoring Patients, Control Patients
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score
Description	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.
Time Frame	Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.

Outcome Measure Data

Analysis Population Description

Caregivers of patients with CKD

Arm/Group Title	Face-to-face Peer Mentoring	Online Peer Mentoring	Control
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.
Measure Participants	29	29	28
Number (95% Confidence Interval) [Scores on a scale / Months]	-2.49	-3.44	-1.26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Face-to-face Peer Mentoring Patients, Online Peer Mentoring Patients, Control Patients
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patient participants

Arm/Group Title	Face-to-face Peer Mentoring	Online Peer Mentoring	Control
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Will not receive peer mentoring.
Measure Participants	52	52	51
Number (95% Confidence Interval) [Scores on a scale / Months]	0.95	5.66	0.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Face-to-face Peer Mentoring Patients, Online Peer Mentoring Patients, Control Patients
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Face-to-face Peer Mentoring Patients		Online Peer Mentoring Patients		Control Patients		Face-to-face Peer Mentoring Caregivers		Online Peer Mentoring Caregivers		Control Caregivers
Arm/Group Description	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.		Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.		Will not receive peer mentoring.		Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.		Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.		Will not receive peer mentoring.
All Cause Mortality
	Face-to-face Peer Mentoring Patients		Online Peer Mentoring Patients		Control Patients		Face-to-face Peer Mentoring Caregivers		Online Peer Mentoring Caregivers		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/52 (5.8%)		4/52 (7.7%)		5/51 (9.8%)		1/29 (3.4%)		1/29 (3.4%)		1/28 (3.6%)
Serious Adverse Events
	Face-to-face Peer Mentoring Patients		Online Peer Mentoring Patients		Control Patients		Face-to-face Peer Mentoring Caregivers		Online Peer Mentoring Caregivers		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)		0/51 (0%)		0/29 (0%)		0/29 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Face-to-face Peer Mentoring Patients		Online Peer Mentoring Patients		Control Patients		Face-to-face Peer Mentoring Caregivers		Online Peer Mentoring Caregivers		Control Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)		0/51 (0%)		0/29 (0%)		0/29 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.