Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT05431894
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Behavioral and Recovery Support for 30 Day Post-Discharge Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned upon consent randomly to an intervention or control group. The intervention group received support from Laguna Coaches for 30 days, the control group did not receive any support from Laguna coaches.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-20', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned All Cause Readmission Rate', 'timeFrame': '30 Days Post-Discharge', 'description': 'Unplanned All-Cause 30 Day Readmission Rate'}, {'measure': 'Unplanned Readmission Total Cost', 'timeFrame': '30 Days Post-Discharge', 'description': 'Billed facility charges for readmissions hospitalization stays'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Readmissions', 'Cardiovascular', 'Post-Discharge', 'Behavioral Health', 'Readmission Cost', '30 Day Readmission', 'Heart Failure', 'Care Management', 'Barriers to Care', 'Contextualizing Healthcare'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '32125402', 'type': 'BACKGROUND', 'citation': 'Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.'}, {'pmid': '30896914', 'type': 'BACKGROUND', 'citation': 'Bailey MK, Weiss AJ, Barrett ML, Jiang HJ. Characteristics of 30-Day All-Cause Hospital Readmissions, 2010-2016. 2019 Feb 12. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #248. Available from http://www.ncbi.nlm.nih.gov/books/NBK538941/'}, {'pmid': '31234205', 'type': 'BACKGROUND', 'citation': 'Panagiotou OA, Kumar A, Gutman R, Keohane LM, Rivera-Hernandez M, Rahman M, Gozalo PL, Mor V, Trivedi AN. Hospital Readmission Rates in Medicare Advantage and Traditional Medicare: A Retrospective Population-Based Analysis. Ann Intern Med. 2019 Jul 16;171(2):99-106. doi: 10.7326/M18-1795. Epub 2019 Jun 25.'}, {'pmid': '24091935', 'type': 'BACKGROUND', 'citation': 'Mitchell SE, Gardiner PM, Sadikova E, Martin JM, Jack BW, Hibbard JH, Paasche-Orlow MK. Patient activation and 30-day post-discharge hospital utilization. J Gen Intern Med. 2014 Feb;29(2):349-55. doi: 10.1007/s11606-013-2647-2. Epub 2013 Oct 4.'}, {'pmid': '26743119', 'type': 'BACKGROUND', 'citation': 'Riegel B, Masterson Creber R, Hill J, Chittams J, Hoke L. Effectiveness of Motivational Interviewing in Decreasing Hospital Readmission in Adults With Heart Failure and Multimorbidity. Clin Nurs Res. 2016 Aug;25(4):362-77. doi: 10.1177/1054773815623252. Epub 2016 Jan 6.'}, {'pmid': '25339632', 'type': 'BACKGROUND', 'citation': 'Villani A, Malfatto G, Compare A, Della Rosa F, Bellardita L, Branzi G, Molinari E, Parati G. Clinical and psychological telemonitoring and telecare of high risk heart failure patients. J Telemed Telecare. 2014 Dec;20(8):468-75. doi: 10.1177/1357633X14555644. Epub 2014 Oct 22.'}, {'pmid': '24239154', 'type': 'BACKGROUND', 'citation': 'Roncella A, Pristipino C, Cianfrocca C, Scorza S, Pasceri V, Pelliccia F, Denollet J, Pedersen SS, Speciale G. One-year results of the randomized, controlled, short-term psychotherapy in acute myocardial infarction (STEP-IN-AMI) trial. Int J Cardiol. 2013 Dec 10;170(2):132-9. doi: 10.1016/j.ijcard.2013.08.094. Epub 2013 Sep 8.'}, {'pmid': '23072736', 'type': 'BACKGROUND', 'citation': 'Allen LA, Smoyer Tomic KE, Smith DM, Wilson KL, Agodoa I. Rates and predictors of 30-day readmission among commercially insured and Medicaid-enrolled patients hospitalized with systolic heart failure. Circ Heart Fail. 2012 Nov;5(6):672-9. doi: 10.1161/CIRCHEARTFAILURE.112.967356. Epub 2012 Oct 16.'}, {'pmid': '19949133', 'type': 'BACKGROUND', 'citation': 'Bhalla R, Kalkut G. Could Medicare readmission policy exacerbate health care system inequity? Ann Intern Med. 2010 Jan 19;152(2):114-7. doi: 10.7326/0003-4819-152-2-201001190-00185. Epub 2009 Nov 30.'}, {'pmid': '34800472', 'type': 'BACKGROUND', 'citation': 'Ogunmoroti O, Osibogun O, Spatz ES, Okunrintemi V, Mathews L, Ndumele CE, Michos ED. A systematic review of the bidirectional relationship between depressive symptoms and cardiovascular health. Prev Med. 2022 Jan;154:106891. doi: 10.1016/j.ypmed.2021.106891. Epub 2021 Nov 17.'}, {'pmid': '33486973', 'type': 'BACKGROUND', 'citation': 'Levine GN, Cohen BE, Commodore-Mensah Y, Fleury J, Huffman JC, Khalid U, Labarthe DR, Lavretsky H, Michos ED, Spatz ES, Kubzansky LD. Psychological Health, Well-Being, and the Mind-Heart-Body Connection: A Scientific Statement From the American Heart Association. Circulation. 2021 Mar 9;143(10):e763-e783. doi: 10.1161/CIR.0000000000000947. Epub 2021 Jan 25.'}, {'pmid': '32686892', 'type': 'BACKGROUND', 'citation': 'Sreenivasan J, Abu-Haniyeh A, Hooda U, Khan MS, Aronow WS, Michos ED, Cooper HA, Panza JA. Rate, causes, and predictors of 90-day readmissions and the association with index hospitalization coronary revascularization following non-ST elevation myocardial infarction in the United States. Catheter Cardiovasc Interv. 2021 Jul 1;98(1):12-21. doi: 10.1002/ccd.29119. Epub 2020 Jul 20.'}, {'pmid': '22010201', 'type': 'BACKGROUND', 'citation': 'Reese RL, Freedland KE, Steinmeyer BC, Rich MW, Rackley JW, Carney RM. Depression and rehospitalization following acute myocardial infarction. Circ Cardiovasc Qual Outcomes. 2011 Nov 1;4(6):626-33. doi: 10.1161/CIRCOUTCOMES.111.961896. Epub 2011 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will provide behavioral and mental health support to a select group of participants to supplement the hospital-provided discharge and recovery plans, based on clinical guidance and dedicated post-hospitalization behavioral protocols, with the goals of reducing readmission rates and costs.', 'detailedDescription': 'This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated clinical guidance and dedicated post-hospitalization Laguna recovery protocols, with the aims of improving health outcomes, reducing health costs, and reducing readmission rates within 30 days post-discharge.\n\nParticipants in the intervention group received support from Laguna Health via phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the hospital with a diagnosis of a cardiovascular disease\n* Discharged to home\n* Converse in English or Spanish\n* Uses a telephone\n\nExclusion Criteria:\n\n* Participant unable to provide informed consent\n* Participant lacks cognitive ability to participate in the study interventions as judged by the primary attending physician'}, 'identificationModule': {'nctId': 'NCT05431894', 'briefTitle': 'Behavioral and Recovery Support for 30 Day Post-Discharge Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laguna Health, Inc'}, 'officialTitle': 'Behavioral and Recovery Support for 30 Day Post-Discharge Care in Participants With Cardiovascular Diseases', 'orgStudyIdInfo': {'id': 'EH21-092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Group received support from Laguna Coaches', 'interventionNames': ['Behavioral: Laguna Coach Intervention Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Group received no support from Laguna Coaches'}], 'interventions': [{'name': 'Laguna Coach Intervention Group', 'type': 'BEHAVIORAL', 'description': "Behavioral and mental support was delivered through personal interactions with Laguna Coaches via phone, video, or web chat. Behavioral and mental support was individualized to best match each patient's needs and strengths. Support was provided to participants through human interactions over approximately 30 days.", 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'overallOfficials': [{'name': 'Alfonso Tafur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endeavor Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laguna Health, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Endeavor Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}