Trial Outcomes & Findings for Peer-mentoring, Quality of Life and Caregiver Burden in Patients With Chronic Kidney Disease and Their Caregivers (NCT NCT02429115)

Last Updated: 2019-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

241 participants

Primary outcome timeframe

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

Results posted on

2019-12-13

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Face-to-face Peer Mentoring Patients n=52 Participants Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Online Peer Mentoring Patients n=52 Participants Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Control Patients n=51 Participants Will not receive peer mentoring.	Face-to-face Peer Mentoring Caregivers n=29 Participants Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Online Peer Mentoring Caregivers n=29 Participants Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Control Caregivers n=28 Participants Will not receive peer mentoring.	Total n=241 Participants Total of all reporting groups
Age, Customized Age ≤ 47	11 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	8 Participants n=8 Participants	70 Participants n=8 Participants
Age, Customized 47< Age ≤ 54	14 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=8 Participants	54 Participants n=8 Participants
Age, Customized 54 <Age ≤ 62	12 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	59 Participants n=8 Participants
Age, Customized 62 < Age	15 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=8 Participants	58 Participants n=8 Participants
Sex/Gender, Customized Male	27 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	11 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=8 Participants	119 Participants n=8 Participants
Sex/Gender, Customized Female	25 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	18 Participants n=4 Participants	20 Participants n=21 Participants	17 Participants n=8 Participants	122 Participants n=8 Participants
Race/Ethnicity, Customized White	24 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	13 Participants n=4 Participants	13 Participants n=21 Participants	14 Participants n=8 Participants	114 Participants n=8 Participants
Race/Ethnicity, Customized Non-white	28 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	16 Participants n=4 Participants	16 Participants n=21 Participants	14 Participants n=8 Participants	127 Participants n=8 Participants
Ethnicity Hispanic	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	25 Participants n=8 Participants
Ethnicity Non-Hispanic	47 Participants n=5 Participants	47 Participants n=7 Participants	44 Participants n=5 Participants	27 Participants n=4 Participants	25 Participants n=21 Participants	26 Participants n=8 Participants	216 Participants n=8 Participants
Marital Status Married	16 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	18 Participants n=8 Participants	116 Participants n=8 Participants
Marital Status Not married	36 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants	10 Participants n=8 Participants	125 Participants n=8 Participants
At least some college Yes	22 Participants n=5 Participants	30 Participants n=7 Participants	25 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	9 Participants n=8 Participants	109 Participants n=8 Participants
At least some college No	30 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants	18 Participants n=4 Participants	17 Participants n=21 Participants	19 Participants n=8 Participants	132 Participants n=8 Participants
Employed Employed	13 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	13 Participants n=21 Participants	12 Participants n=8 Participants	82 Participants n=8 Participants
Employed Not Employed	39 Participants n=5 Participants	35 Participants n=7 Participants	35 Participants n=5 Participants	18 Participants n=4 Participants	16 Participants n=21 Participants	16 Participants n=8 Participants	159 Participants n=8 Participants
Rural Rural	4 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants	8 Participants n=8 Participants	45 Participants n=8 Participants
Rural Urban	48 Participants n=5 Participants	45 Participants n=7 Participants	42 Participants n=5 Participants	23 Participants n=4 Participants	18 Participants n=21 Participants	20 Participants n=8 Participants	196 Participants n=8 Participants

PRIMARY outcome

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

Population: Patient participants.

Outcome measures

Outcome measures
Measure	Face-to-face Peer Mentoring Patients n=52 Participants Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Online Peer Mentoring Patients n=52 Participants Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Control Patients n=51 Participants Will not receive peer mentoring.
Slope of Change in Kidney Disease Quality of Life-36 Score Effects of Kidney Disease	2.21 Scores on a scale / Months Interval -1.1 to 5.52	4.13 Scores on a scale / Months Interval 0.87 to 7.4	-0.50 Scores on a scale / Months Interval -3.97 to 2.97
Slope of Change in Kidney Disease Quality of Life-36 Score Burden of Kidney Disease	3.00 Scores on a scale / Months Interval -1.27 to 7.27	5.44 Scores on a scale / Months Interval 1.24 to 9.63	-0.99 Scores on a scale / Months Interval -5.5 to 3.53
Slope of Change in Kidney Disease Quality of Life-36 Score Short Form-12 Physical Composite	0.64 Scores on a scale / Months Interval -0.94 to 2.22	2.50 Scores on a scale / Months Interval 0.95 to 4.06	-0.70 Scores on a scale / Months Interval -2.36 to 0.97
Slope of Change in Kidney Disease Quality of Life-36 Score Short Form-12 Mental Composite Score	1.43 Scores on a scale / Months Interval -0.28 to 3.13	3.46 Scores on a scale / Months Interval 1.78 to 5.13	1.13 Scores on a scale / Months Interval -0.66 to 2.92
Slope of Change in Kidney Disease Quality of Life-36 Score Symptoms/Problems of Kidney Disease	3.41 Scores on a scale / Months Interval -0.46 to 6.36	6.00 Scores on a scale / Months Interval 3.09 to 8.91	-2.71 Scores on a scale / Months Interval -6.2 to 0.78

PRIMARY outcome

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

Population: Caregivers of patients with CKD

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.

Outcome measures

Outcome measures
Measure	Face-to-face Peer Mentoring Patients n=29 Participants Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Online Peer Mentoring Patients n=29 Participants Will receive 6 months of online peer mentoring by a trained peer mentor. Mentoring: Six months of peer-mentoring.	Control Patients n=28 Participants Will not receive peer mentoring.
Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score	-2.49 Scores on a scale / Months Interval -5.85 to 0.87	-3.44 Scores on a scale / Months Interval -6.31 to -0.57	-1.26 Scores on a scale / Months Interval -4.06 to 1.54

SECONDARY outcome

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

Population: Patient participants

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.