Chronic Kidney DiseaseNCT02429115

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

A study testing Mentoring in people with Chronic Kidney Disease, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Mentoring
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 1 siteUnited States
Study dates: 12 Feb 2015to 30 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Kidney Foundation of Central Pennsylvania
Harrisburg, Pennsylvania, 17104

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Chronic Kidney Disease
Being tested: Mentoring
Keywords: peer mentoring, chronic kidney disease, quality of life, pcori, caregiver burden
Medical subject headings: Renal Insufficiency, Chronic, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MentoringOther
Six months of peer-mentoring.

Study groups in NCT02429115
Study group	Role	What they receive
Face-to-face peer mentoring	Experimental	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Receives: Other: Mentoring
Online peer mentoring	Experimental	Will receive 6 months of face-to-face peer mentoring by a trained peer mentor. Receives: Other: Mentoring
Control	No intervention	Will not receive peer mentoring.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 201530 Jun 2018

First posted29 Apr 2015 (estimated)
Study start12 Feb 2015
Primary completion30 Apr 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02429115
Sponsor's protocol ID: CDR-1310-07055
Status last verified: Nov 2019
First submitted: 21 Apr 2015
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02429115
Acronym / sponsor ID: CDR-1310-07055
Conditions: Chronic Kidney Disease
Keywords: peer mentoring, chronic kidney disease, quality of life, pcori, caregiver burden
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 12 Feb 2015 (actual)
Primary completion: 30 Apr 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 29 Apr 2015 (estimated)
Results: Posted 13 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Face-to-face peer mentoring	Experimental	Other: MentoringWill receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Online peer mentoring	Experimental	Other: MentoringWill receive 6 months of face-to-face peer mentoring by a trained peer mentor.
Control	No intervention	–Will not receive peer mentoring.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MentoringSix months of peer-mentoring.	Other	Face-to-face peer mentoring, Online peer mentoring

Primary outcome

Slope of Change in Kidney Disease Quality of Life-36 Score
Time frame: 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.
Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 13 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Face-to-face Peer Mentoring Patients	52	40
Online Peer Mentoring Patients	52	42
Control Patients	51	35
Face-to-face Peer Mentoring Caregivers	29	21
Online Peer Mentoring Caregivers	29	22
Control Caregivers	28	27

Primary outcome: Slope of Change in Kidney Disease Quality of Life-36 Score

Time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.. Number (95% Confidence Interval). Unit: Scores on a scale / Months

Measure	Face-to-face Peer Mentoring Patients n = 52	Online Peer Mentoring Patients n = 52	Control Patients n = 51
Effects of Kidney Disease	2.21 (-1.10 to 5.52)	4.13 (0.87 to 7.40)	-0.50 (-3.97 to 2.97)
Burden of Kidney Disease	3.00 (-1.27 to 7.27)	5.44 (1.24 to 9.63)	-0.99 (-5.50 to 3.53)
Short Form-12 Physical Composite	0.64 (-0.94 to 2.22)	2.50 (0.95 to 4.06)	-0.70 (-2.36 to 0.97)
Short Form-12 Mental Composite Score	1.43 (-0.28 to 3.13)	3.46 (1.78 to 5.13)	1.13 (-0.66 to 2.92)
Symptoms/Problems of Kidney Disease	3.41 (-0.46 to 6.36)	6.00 (3.09 to 8.91)	-2.71 (-6.20 to 0.78)

Face-to-face Peer Mentoring Patients vs Online Peer Mentoring Patients vs Control Patients: p <0.05, ANOVA

Population analysed: Patient participants.

Primary outcome: Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score

Time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.. Number (95% Confidence Interval). Unit: Scores on a scale / Months

Measure	Face-to-face Peer Mentoring n = 29	Online Peer Mentoring n = 29	Control n = 28
Value	-2.49 (-5.85 to 0.87)	-3.44 (-6.31 to -0.57)	-1.26 (-4.06 to 1.54)

Face-to-face Peer Mentoring vs Online Peer Mentoring vs Control: p <0.05, ANOVA

Population analysed: Caregivers of patients with CKD

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Face-to-face Peer Mentoring Patients	0 of 52 (0%)	0 of 52 (0%)	3 of 52
Online Peer Mentoring Patients	0 of 52 (0%)	0 of 52 (0%)	4 of 52
Control Patients	0 of 51 (0%)	0 of 51 (0%)	5 of 51
Face-to-face Peer Mentoring Caregivers	0 of 29 (0%)	0 of 29 (0%)	1 of 29
Online Peer Mentoring Caregivers	0 of 29 (0%)	0 of 29 (0%)	1 of 29
Control Caregivers	0 of 28 (0%)	0 of 28 (0%)	1 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nasrollah Ghahramani, MD principal investigator

Penn State College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mentoring in people with Chronic Kidney Disease, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Slope of Change in Kidney Disease Quality of Life-36 Score (time frame: Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02429115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.