Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT05400720
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peer Support In Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "We aim to conduct the study over 6 to 12 months to obtain enough experience to enable feasibility evaluation.\n\nMentor pool sample size: We anticipate having about 10 patients in the mentors' pool during the study period.\n\nMentee sample size: We anticipate approaching between 20 to 30 dialysis patients over the study period.\n\nSupporting team: All members of the supporting staff will be invited to participate."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-26', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mentor', 'timeFrame': '6 - 12 months', 'description': 'Number of patients registering to become mentors, percent of those registered completing mentor training and percent of trained mentors who meet at least one mentee.'}, {'measure': 'Mentee', 'timeFrame': '1 month', 'description': 'Number and proportion of patients starting dialysis, or prevalent dialysis patients identified by the clinical team to need peer support, who receive an introductory peer mentor visit. Number and % of mentees who indicate interest to continue with more peer mentoring visits.'}], 'secondaryOutcomes': [{'measure': 'Mentor Perspectives', 'timeFrame': '6-12month', 'description': 'Evaluation of recruitment, training and program. Data collection will be through the Mentor Recruitment and Training Evaluation form and through focus group discussions'}, {'measure': 'Mentee Perspectives', 'timeFrame': '1-4 weeks', 'description': 'Peer Mentorship Program Evaluation - Mentee form to be completed by the mentee to collect data on the mentees perspective of the program'}, {'measure': 'Support Staff Perspectives', 'timeFrame': '3,6,9 and 12 months', 'description': 'Peer Mentorship Program Evaluation - Staff to be completed by the center staff to collect data on their perspective of the program'}, {'measure': 'Mentor - Mentee Matching', 'timeFrame': '1 month', 'description': 'Preferences about matching (n and % for age range, gender, race, language, social conditions, specific dialysis experiences \\[e.g. Peritoneal Dialysis / Home HemoDialysis / transplant\\], and others).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '29722062', 'type': 'BACKGROUND', 'citation': 'Bennett PN, St Clair Russell J, Atwal J, Brown L, Schiller B. Patient-to-patient peer mentor support in dialysis: Improving the patient experience. Semin Dial. 2018 Sep;31(5):455-461. doi: 10.1111/sdi.12703. Epub 2018 May 2.'}, {'type': 'BACKGROUND', 'citation': 'Collins, K. (2016). NKF Peers Mentoring Program. National Kidney Foundation Journal of Nephrology Social Work, 40(2), 25-33.'}, {'type': 'BACKGROUND', 'citation': "Fida'Husain, H. K., & Johan, A. (2020). Effects of Peer Support Program on Self-Management in Patients with End-Stage Renal Disease Undergoing Hemodialysis."}, {'pmid': '35373037', 'type': 'BACKGROUND', 'citation': 'Flythe JE, Narendra JH, Yule C, Manivannan S, Murphy S, Lee SD, Strigo TS, Peskoe S, Pendergast JF, Boulware LE, Green JA. Targeting Patient and Health System Barriers To Improve Rates of Hemodialysis Initiation with an Arteriovenous Access. Kidney360. 2021 Feb 26;2(4):708-720. doi: 10.34067/KID.0007812020. eCollection 2021 Apr 29.'}, {'pmid': '34717865', 'type': 'BACKGROUND', 'citation': 'Hussein WF, Bennett PN, Schiller B. Innovations to Increase Home Hemodialysis Utilization: The Transitional Care Unit. Adv Chronic Kidney Dis. 2021 Mar;28(2):178-183. doi: 10.1053/j.ackd.2021.02.009.'}, {'pmid': '26594739', 'type': 'BACKGROUND', 'citation': 'Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649.'}, {'pmid': '29281772', 'type': 'BACKGROUND', 'citation': 'St Clair Russell J, Southerland S, Huff ED, Thomson M, Meyer KB, Lynch JR. A Peer-to-Peer Mentoring Program for In-Center Hemodialysis: A Patient-Centered Quality Improvement Program. Nephrol Nurs J. 2017 Nov-Dec;44(6):481-496.'}], 'seeAlsoLinks': [{'url': 'https://partnershipforpatients.cms.gov/about-the-partnership/patient-and-family-engagement/the-patient-and-family-engagement.html', 'label': 'Centers for Medicare and Medicaid Services (CMS). (2021). Partnership for patients.'}, {'url': 'https://esrdncc.org/en/patients/peer-mentoring-resources/', 'label': 'ESRD National Coordinating Center. (2021). ESRD Networks Peer Mentor Program.'}, {'url': 'http://dx.doi.org/10.37526/1526-744X.2021.48.4.399', 'label': 'Lessons Learned: Implementation of a Peer-to-Peer Mentor Program in Individuals Requiring Hemodialysis.'}]}, 'descriptionModule': {'briefSummary': 'Peer mentoring is an approach used to support patients through their experience. In the End Stage Kidney Disease community many patients find out about their kidney failure without warning. This study is designed to test the feasibility of a structured peer support program, specifically, patient uptake, engagement and patient and staff perspectives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Mentor Patient Participants Inclusion criteria:\n\n* Patients living with dialysis or kidney transplant, who volunteer to support other patients.\n* Mentor participants agree to complete the CMS End Stage Renal Disease Network Peer Mentoring training program (https://www.kidneylearninghub.com/patients-peer-mentoring-program/ ) and follow the guidelines for participation in the program.\n\nMentor Patient Participants Exclusion criteria:\n\n* Age \\<18 years.\n* Patient cannot communicate in English.\n* Concerns raised by the clinical team that may expose the mentor, mentee, staff, or the program to risks, as identified by the clinical team and discussed with the principal investigator.\n\nMentee Patient Participants Inclusion criteria:\n\n* All incident (new) dialysis patients or their care partners, within the first three months of dialysis.\n\nOR\n\n* Prevalent dialysis patients or their care partners identified by the clinical team to need peer support.\n\nMentee Patient Participants Exclusion criteria:\n\n* Age \\< 18 years.\n* Significant physical or psychological health conditions (including cognitive impairment) that would limit the patient's ability to interact with the mentor, AND care partner not available or reachable to join the program.\n* This criteria will be subjectively evaluated by the clinical team.\n\nClinical and administrative staff supporting the program inclusion criteria\n\n* referring physicians, the medical director of the center, social workers, nurses, patient care technicians (PCT), certified clinical hemodialysis technicians (CCHT), and administrative staff.\n* Support staff are those who interact with mentors or mentees as part of their routine work.\n* Formally participate in supporting the program by identifying candidates, introducing them to the program, or providing them with support."}, 'identificationModule': {'nctId': 'NCT05400720', 'briefTitle': 'Peer Support In Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Peer Support In Dialysis: A Feasibility Study', 'orgStudyIdInfo': {'id': 'SIH131_Peer Mentoring'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mentee', 'description': 'Participants will be approached by a mentor, exchange experiences and invite the prospective mentee to the program. Those interested to continue will undergo matching based on their desired criteria.', 'interventionNames': ['Behavioral: Mentoring']}], 'interventions': [{'name': 'Mentoring', 'type': 'BEHAVIORAL', 'description': 'At least one meeting between the mentor and mentee will occur to share experiences and see if the mentee would like to continue meeting with a mentor', 'armGroupLabels': ['Mentee']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Mountain View', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'WellBound Mountain View', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Wael Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}