Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-02-26 @ 11:16 AM
Study NCT ID:
NCT02938351
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Collaborative Care Intervention for Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'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': 'Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Level', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on CES-D questionnaire'}, {'measure': 'Perceived Stress level', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on PSS questionnaire'}, {'measure': 'degree of Pain', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on the BPI questionnaire'}], 'secondaryOutcomes': [{'measure': 'Dyadic functioning', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on the Dyadic functioning questionnaire'}, {'measure': 'level of physical activity (mild, moderate or high)', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'calculated score on the International Physical Activity quationnaire'}, {'measure': 'sleep quality', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on the PSQI questionnaire'}, {'measure': 'quality of life', 'timeFrame': 'change from baseline at 3 month and 6 month', 'description': 'score on the KDQOL questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Collaborative care intervention', 'kidney transplant'], 'conditions': ['Kidney Transplant', 'Depression', 'Pain']}, 'referencesModule': {'references': [{'pmid': '40643797', 'type': 'DERIVED', 'citation': 'Kallem CJ, Tevar AA, Bradley T, Jackson H, Haggerty D, Cheng H, Pathak R, Wang Y, Carney M, Gardner S, Deshpande A, Jhamb M, Steel JL. A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients awaiting kidney transplantation (CARES-transplant). J Behav Med. 2025 Oct;48(5):731-744. doi: 10.1007/s10865-025-00574-x. Epub 2025 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.', 'detailedDescription': 'Symptom management is critical to maintain quality of life in those with life limiting conditions. Stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. Collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. The aims of the present study were to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English\n\nExclusion Criteria:\n\nUnder the age of 18 years or over 90 years Not fluent in English'}, 'identificationModule': {'nctId': 'NCT02938351', 'briefTitle': 'Collaborative Care Intervention for Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Collaborative Care Intervention for Kidney Transplant Patients', 'orgStudyIdInfo': {'id': 'PRO15110210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'collaborative care', 'description': 'To test the efficacy of a collaborative care intervention with patients treated with dialysis to reduce depression, pain, fatigue, and improve quality of life', 'interventionNames': ['Behavioral: Collaborative care']}], 'interventions': [{'name': 'Collaborative care', 'type': 'BEHAVIORAL', 'description': 'Therapist will use iPad (Vidyo) once a week during dialysis for approximately one hour. The therapist will teach the patient cognitive-behavioral strategies to manage their mood and pain. The PI is a clinical psychologist and will provide supervision to the therapist providing the intervention. The sessions for depression will include (1) intake, (2) review of the rational for using CBT to treat depression and/or pain, (3) identifying thought patterns, (4) changing thought patterns, (5) relaxation techniques, (6) rest-activity pacing, and (7) coping strategies. Homework to practice these techniques will be provided after each session.', 'armGroupLabels': ['collaborative care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jennifer Steel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Physicians'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Jennifer Steel', 'investigatorAffiliation': 'University of Pittsburgh'}}}}