Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT04897061
Status:
COMPLETED
Last Update Posted:
2022-11-22
First Post:
2021-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caregiver Support and Post-operative Convalescence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Recovery 15 (QOR-15)', 'timeFrame': 'Post-operative day 3, 7, 14, and 28', 'description': 'Changes in Quality of Recovery 15 (QOR-15) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28.\n\nQOR-15 is a 15 item instrument, full score range from 0 to 150, with higher score indicating better health outcomes.'}, {'measure': 'Change in Post-discharge Surgical Recovery 13 (PSR-13)', 'timeFrame': 'Post-operative day 3, 7, 14, and 28', 'description': 'Changes in Post-discharge Surgical Recovery 13 (PSR-13) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28..\n\nThe PSR scale is a 13 items instrument, full score range from 0-100, with higher score indicating better recovery.'}], 'secondaryOutcomes': [{'measure': 'Change in Healthcare utilization composite score', 'timeFrame': 'Post-operative day 3, 7, 14, and 28', 'description': 'Changes in a composite score comprised of healthcare utilization of phone calls, unanticipated office visits, and emergency department (ED) visits based on a priori caregiver characteristics on post-operative day 3, 7, 14, and 28.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prolapse', 'Same day discharge', 'Caregiver'], 'conditions': ['Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '20557414', 'type': 'BACKGROUND', 'citation': 'Berg K, Idvall E, Nilsson U, Arestedt KF, Unosson M. Psychometric evaluation of the post-discharge surgical recovery scale. J Eval Clin Pract. 2010 Aug;16(4):794-801. doi: 10.1111/j.1365-2753.2009.01197.x. Epub 2010 Jun 14.'}, {'pmid': '11130605', 'type': 'BACKGROUND', 'citation': 'Kleinbeck SV. Self-reported at-home postoperative recovery. Res Nurs Health. 2000 Dec;23(6):461-72. doi: 10.1002/1098-240X(200012)23:63.0.CO;2-S.'}, {'pmid': '22924755', 'type': 'BACKGROUND', 'citation': 'Lassen PD, Moeller-Larsen H, DE Nully P. Same-day discharge after laparoscopic hysterectomy. Acta Obstet Gynecol Scand. 2012 Nov;91(11):1339-41. doi: 10.1111/j.1600-0412.2012.01535.x. Epub 2012 Oct 17.'}, {'pmid': '24005979', 'type': 'BACKGROUND', 'citation': 'Manohar A, Cheung K, Wu CL, Stierer TS. Burden incurred by patients and their caregivers after outpatient surgery: a prospective observational study. Clin Orthop Relat Res. 2014 May;472(5):1416-26. doi: 10.1007/s11999-013-3270-6.'}, {'pmid': '29846193', 'type': 'BACKGROUND', 'citation': 'Myles PS. Measuring quality of recovery in perioperative clinical trials. Curr Opin Anaesthesiol. 2018 Aug;31(4):396-401. doi: 10.1097/ACO.0000000000000612.'}, {'pmid': '11964610', 'type': 'BACKGROUND', 'citation': 'Wu CL, Berenholtz SM, Pronovost PJ, Fleisher LA. Systematic review and analysis of postdischarge symptoms after outpatient surgery. Anesthesiology. 2002 Apr;96(4):994-1003. doi: 10.1097/00000542-200204000-00030. No abstract available.'}, {'pmid': '23148514', 'type': 'BACKGROUND', 'citation': 'Berg K, Kjellgren K, Unosson M, Arestedt K. Postoperative recovery and its association with health-related quality of life among day surgery patients. BMC Nurs. 2012 Nov 13;11(1):24. doi: 10.1186/1472-6955-11-24.'}, {'pmid': '29212492', 'type': 'BACKGROUND', 'citation': 'Bouwsma EVA, Anema JR, Vonk Noordegraaf A, de Vet HCW, Huirne JAF. Using patient data to optimize an expert-based guideline on convalescence recommendations after gynecological surgery: a prospective cohort study. BMC Surg. 2017 Dec 6;17(1):129. doi: 10.1186/s12893-017-0317-8.'}, {'pmid': '28230616', 'type': 'BACKGROUND', 'citation': 'Carpenter JS, Heit M, Chen CX, Stewart R, Hamner J, Rand KL. Validating the Postdischarge Surgical Recovery Scale 13 as a Measure of Perceived Postoperative Recovery After Laparoscopic Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):86-89. doi: 10.1097/SPV.0000000000000352.'}, {'pmid': '26787793', 'type': 'BACKGROUND', 'citation': 'Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.'}, {'pmid': '29716589', 'type': 'BACKGROUND', 'citation': 'Dambi JM, Corten L, Chiwaridzo M, Jack H, Mlambo T, Jelsma J. A systematic review of the psychometric properties of the cross-cultural translations and adaptations of the Multidimensional Perceived Social Support Scale (MSPSS). Health Qual Life Outcomes. 2018 May 2;16(1):80. doi: 10.1186/s12955-018-0912-0.'}, {'pmid': '22433341', 'type': 'BACKGROUND', 'citation': 'Evenson M, Payne D, Nygaard I. Recovery at home after major gynecologic surgery: how do our patients fare? Obstet Gynecol. 2012 Apr;119(4):780-4. doi: 10.1097/AOG.0b013e31824bb15e.'}, {'pmid': '29923843', 'type': 'BACKGROUND', 'citation': 'Heit M, Carpenter JS, Chen CX, Stewart R, Hamner J, Rand KL. Predictors of Postdischarge Surgical Recovery Following Laparoscopic Sacrocolpopexy: A Prospective Cohort Study. Female Pelvic Med Reconstr Surg. 2020 May;26(5):320-326. doi: 10.1097/SPV.0000000000000599.'}, {'pmid': '29397134', 'type': 'BACKGROUND', 'citation': 'Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study designed to investigate the impact of home caregiver support on post-operative convalescence in patients undergoing same day discharge after major urogynecologic surgery. Questionnaires assessing post-operative convalescence will be distributed at several time points after surgery. The main hypothesis is that increased caregiver support in the post-operative period will improve post-operative convalescence of patients undergoing major urogynecologic surgery.', 'detailedDescription': "Pelvic organ prolapse and incontinence surgery is now often done on an outpatient basis (also known as same day discharge surgery or SDD). While there are data to support the safety of this practice, little is known about the burden and demands of this practice on the patient and her support system/caregivers. Furthermore, there are no guidelines on requirements for assistance at home or what impact home caregiver support has on recovery. The study team is interested in investigating the spectrum of support that patients have at home in terms of caregivers such as family, friends, neighbors and how that may impact their recovery. The intervention for this study will be comprised of administering post-operative questionnaires that assess patients' post-operative convalescence and quantify the required or available caregiver support. The clinical outcome of interest is recovery as assessed by the validated questionnaires."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women age 18 years or older undergoing major pelvic organ prolapse surgery (vaginal apical suspension, laparoscopic or robotic apical suspension, obliterative procedure) or minor prolapse or incontinence procedure with concomitant hysterectomy.', 'genderDescription': 'Only female patients are eligible to investigate post-operative recovery and convalescence after urogynecologic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* English speaking\n* Successfully discharged on the day of surgery\n\nExclusion Criteria:\n\n* Discharge to a nursing home, assisted living or rehabilitation facility.\n* Dementia or altered mental status that would make recall of recovery process unreliable.\n* Inability to access Internet or phone for study participation'}, 'identificationModule': {'nctId': 'NCT04897061', 'briefTitle': 'Caregiver Support and Post-operative Convalescence', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery', 'orgStudyIdInfo': {'id': 'IRB 20-01766'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants undergoing major pelvic organ prolapse surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ann Tran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'Ann Tran', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}