Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT01864369
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life: Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '12 months', 'description': 'The primary outcome in CHF-CePPORT is quality of life, as measured by the number of subjects who demonstrate a clinically meaningful increase of ≥5 points on the summary index of the Kansas City Cardiomyopathy Questionnaire (KCCQ).'}], 'secondaryOutcomes': [{'measure': 'Program engagement and usability', 'timeFrame': '4- and 12- months', 'description': 'Active engagement with digital platform: total time, # logons, % material accessed'}, {'measure': 'Behavioral,functional and clinical outcomes', 'timeFrame': '4- and 12- months', 'description': 'Quality of life: number of subjects with KCCQ ≥5 points'}, {'measure': 'Behavioral, clinical and funcitonal outcomes', 'timeFrame': '4 and 12- months', 'description': 'Adherence to daily dietary guidelines for fruit and vegetable intake: NIH/NCI Diet History Questionnaire.'}, {'measure': 'Behavioral, functional and clinical outcomes', 'timeFrame': '4- and 12- months', 'description': 'Physical activity: 4-day step count with Triaxial Accelerometer.'}, {'measure': 'Behavioral, functional and clinical outcomes', 'timeFrame': '4- and 12- months', 'description': 'Self-reported daily activity: The Physical Activity Scale for the Elderly.'}, {'measure': 'Behavioral, functional and clinical outcomes', 'timeFrame': '4- and 12- months', 'description': 'Psychological adjustment: Patient Health Questionnaire - 9-item scale (Depression)'}, {'measure': 'Clinical and functional assesments.', 'timeFrame': '12-months', 'description': 'Functional capacity: 6-minute walk test.'}, {'measure': 'Behavioral, functional and clinical outcomes', 'timeFrame': '4- and 12- months', 'description': 'Patient Health Questionnaire: PHQ-9 (Depression) and GAD-7 (Anxiety)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'e-counseling', 'quality of life', 'self-care'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38683439', 'type': 'DERIVED', 'citation': 'Nolan RP, Syed F, Stogios N, Maunder R, Sockalingam S, Tai ES, Cobain M, Peiris RG, Huszti E. The evaluation of goal-directed activities to promote well-being and health in heart failure: EUROIA scale. J Patient Rep Outcomes. 2024 Apr 29;8(1):47. doi: 10.1186/s41687-024-00723-x.'}, {'pmid': '33464959', 'type': 'DERIVED', 'citation': "Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19."}, {'pmid': '24480783', 'type': 'DERIVED', 'citation': "Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, Barr SI, Gwadry-Sridhar F, Nigam A, Perreault S, Farkouh M, McDonald M, Goodman J, Thomas S, Zieroth S, Isaac D, Oh P, Rajda M, Chen M, Eysenbach G, Liu S, Zbib A. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2014 Jan 30;3(1):e5. doi: 10.2196/resprot.2957."}], 'seeAlsoLinks': [{'url': 'http://cardiacehealth.uhnresearch.ca/', 'label': 'General contact'}]}, 'descriptionModule': {'briefSummary': 'Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources.\n\nThis year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors, program engagement, and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic HF") corresponding to New York Heart Association Class II-III for 3 months prior to enrolment;\n2. documentation of LVEF 40%;\n3. subject has access to a personal computer;\n\nExclusion Criteria:\n\n1. Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;\n2. persistent systolic or diastolic hypertension \\[systolic \\> 170 mmHg or diastolic \\> 100 mmHg despite antihypertensive therapy;\n3. CHF secondary to cardiovascular co-morbidities/procedures;\n4. previous heart transplant or wait listed for heart transplant at time of enrolment'}, 'identificationModule': {'nctId': 'NCT01864369', 'acronym': 'CHF-CePPORT', 'briefTitle': 'Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT', 'orgStudyIdInfo': {'id': 'MOP 126118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control: eInfo + Usual Care', 'description': 'Usual Care + eInfo on general guidelines for heart healthy living', 'interventionNames': ['Behavioral: eCounseling + Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Behavioral: eCounseling + Usual Care', 'description': 'Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.', 'interventionNames': ['Behavioral: eCounseling + Usual Care']}], 'interventions': [{'name': 'eCounseling + Usual Care', 'type': 'BEHAVIORAL', 'description': 'This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject\'s stage of "readiness" for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of "change talk" to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12.', 'armGroupLabels': ['Behavioral: eCounseling + Usual Care', 'Control: eInfo + Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St.Paul's Hospital- UBC", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Robert P Nolan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network- University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Stroke Foundation of Ontario', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Psychologist- Director, Behavioral Cardiology Research Unit', 'investigatorFullName': 'Robert Nolan', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}