Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03388918
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2017-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Future Patient - Telerehabilitation of Heart Failure Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2017-08-24', 'studyFirstSubmitQcDate': '2017-12-25', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased quality of life', 'timeFrame': 'Intervention group: At baseline, week 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32, 34,36,38,40,42,44,46,48,50,52 Control group: Baseline, 6 & 12 months', 'description': 'Increased quality of life as measured by a moderate change (10 points) in quality of life measured by Kansas City Questionnaire (KCCQ)'}], 'secondaryOutcomes': [{'measure': 'Time from baseline to optimized medical treatment', 'timeFrame': 'For both intervention and control group: From date of randomization until the date of first documented progression with medical treatment, assessed up to 4 months', 'description': 'Time for optimizing medicine'}, {'measure': 'All cause hospitalization', 'timeFrame': 'For both intervention and control group: 6 months', 'description': 'All-cause hospitalization at end of rehabilitation'}, {'measure': 'Steps taken', 'timeFrame': 'Intervention group: Everyday for 12 months', 'description': 'Numbers of steps taken in the intervention group'}, {'measure': 'Development of bloodpressure', 'timeFrame': 'Intervention group: Blood pressure (mmHG) from date of randomization twice a week assessed up to 3 months', 'description': 'Intervention group: Blood pressure (mmHG)'}, {'measure': 'Development of pulse', 'timeFrame': 'Intervention group: Pulse from date of randomization and every day in 12 months', 'description': 'Intervention group: Pulse ( numbers per minutes)'}, {'measure': 'Development of weight', 'timeFrame': 'Intervention group: Weight from date of randomization and every day in 12 months', 'description': 'Intervention group: Weight (Kilograms)'}, {'measure': 'Sleep', 'timeFrame': 'Intervention group: Sleep from date of randomization and accessed up to 12 months', 'description': 'Intervention group: Sleep ( numbers of hours per night)'}, {'measure': 'Illness perception', 'timeFrame': 'For Intervention and control group: At baseline, 6 & 12 months', 'description': 'Positive changes in illness perceptions, from dysfunctional to functional measured by Illness perception questionaire'}, {'measure': 'Motivation', 'timeFrame': 'For both intervention and control group: At baseline, 6 & 12 months', 'description': 'Changes from extrinsic to intrinsic motivation measured from baseline to end of rehabilitation and 6 months after end of rehabilitation measured by Health Climate Change Questionaire'}, {'measure': 'Anxiety and depression', 'timeFrame': 'For both intervention and control group: At baseline, 6 & 12 months', 'description': 'Explore whether levels of anxiety and depression in the intervention group are lower or equivalent to the control group measured by Hospital Anxiety and Depression Scale (HADS) questionnaire'}, {'measure': 'Health- literacy', 'timeFrame': 'For both intervention and control group: At baseline', 'description': 'Health literacy in intervention and control group measured by Health Literacy Questionnaire (Danish validated version HLQ) by units on a scale'}, {'measure': 'eHealth literacy', 'timeFrame': 'For both intervention and control group: At baseline, 6 & 12 months', 'description': 'Improvement in e-health literacy in intervention and control group measured by eHealth Literacy Questionnaire (Danish validated version eHLQ) by units on a scale'}, {'measure': 'Experiences of using the Heart portal', 'timeFrame': 'For intervention group: 6 & 12 months', 'description': 'Qualitative exploration of experiences of HF patients, relatives and healthcare professionals use of the Heart portal'}, {'measure': 'Costs of healthcare and rehabilitation services', 'timeFrame': 'For both intervention and control group: 6 months', 'description': 'Number of hospitalizations, number of contacts with heart failure clinic, days at hospital, contacts with general practitioners, number of participations in rehabilitation activities at healthcare center between intervention and control group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Telerehabilitation', 'Cardiac patients', 'Heart failure'], 'conditions': ['Heart Failure NYHA Class I', 'Heart Failure NYHA Class II', 'Heart Failure NYHA Class III', 'Heart Failure NYHA Class IV', 'Acute Decompensated Heart Failure']}, 'referencesModule': {'references': [{'pmid': '35928510', 'type': 'DERIVED', 'citation': 'Spindler H, Dyrvig AK, Schacksen CS, Anthonimuthu D, Frost L, Gade JD, Kronborg SH, Mahboubi K, Refsgaard J, Dinesen B, Hollingdal M, Kayser L. Increased motivation for and use of digital services in heart failure patients participating in a telerehabilitation program: a randomized controlled trial. Mhealth. 2022 Jul 20;8:25. doi: 10.21037/mhealth-21-56. eCollection 2022.'}, {'pmid': '34255642', 'type': 'DERIVED', 'citation': 'Skov Schacksen C, Dyrvig AK, Henneberg NC, Dam Gade J, Spindler H, Refsgaard J, Hollingdal M, Dittman L, Dremstrup K, Dinesen B. Patient-Reported Outcomes From Patients With Heart Failure Participating in the Future Patient Telerehabilitation Program: Data From the Intervention Arm of a Randomized Controlled Trial. JMIR Cardio. 2021 Jul 2;5(2):e26544. doi: 10.2196/26544.'}, {'pmid': '31538944', 'type': 'DERIVED', 'citation': 'Dinesen B, Dittmann L, Gade JD, Jorgensen CK, Hollingdal M, Leth S, Melholt C, Spindler H, Refsgaard J. "Future Patient" Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Sep 19;8(9):e14517. doi: 10.2196/14517.'}]}, 'descriptionModule': {'briefSummary': "The idea behind the Future Patient research project is to develop a telerehabilitation program and tools for patients with heart failure.\n\nThe hypothesis for this study is that participation in a telerehabilitation program for patients with heart failure will increase the patients' quality of life and multi-parametric (subjective and objective) individualized monitoring in a telerehabilitation program for patients with heart failure will increase detection of worsening of symptoms and avoid future hospitalization of the HF-patients.", 'detailedDescription': 'The overall aim is to test, implement and evaluate a telerehabilitation program for patients with heart failure from clinical, psychosocial, health literacy and e-health literacy, inter-organizational, health economic and technical perspectives.\n\nFurthermore, this study has sub aims:\n\n* To increase the quality of life for patients with Heart Failure (HF)\n* To optimize the medical treatment of patients with HF\n* To perform multi-parametric (subjective and objective) individualized monitoring in order to detect worsening of symptoms and avoid hospitalizations\n* To increase physical activities for patients with heart failure in everyday life in a telerehabilitation program\n* To facilitate patient-initiated self-care management actions upon the following early detection of changes in source data (steps taken, weight, blood pressure, pulse, sleep, illness perception, motivation, anxiety and depression)\n* To evaluate patients health literacy and e-health literacy participating in a telerehabilitation program and rehabilitation program\n* To test and evaluate the Heart Portal - a digital toolbox for improved self-management for patients with heart failure and their relatives\n* To explore the experiences and perspectives of the patients and their relatives when being part of a telerehabilitation program\n* To test and evaluate a cross sector communication platform from a patient and healthcare professional perspective\n* To perform a cost-effectiveness analysis of total costs of healthcare and rehabilitation services'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with HF according to New York Heart Association (NYHA) Class I-IV with max 20 % in class I or who have a current hospitalization for acute decompensated HF within the past two weeks\n* Adults (18 years or older); no upper age limit\n* Patients living in Viborg and Skive Municipality\n* Living at home and capable of caring for him/herself\n* Have basic computer skills or a relative who have basic computer skills\n* Informed consent to participate in a telerehabilitation program\n* May have a pacemaker\n\nExclusion Criteria:\n\n* Pregnancy\n* Drug addiction defined as the use of cannabis, opioids or other drugs\n* Previous neurologic, musculoskeletal or cognitive disability or active psychiatric history (as noted in the medical record) other than depression or anxiety related to cardiac or other chronic illness\n* Lack of ability to cooperate\n* Does not speak Danish'}, 'identificationModule': {'nctId': 'NCT03388918', 'briefTitle': 'Future Patient - Telerehabilitation of Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Future Patient - Telerehabilitation of Heart Failure Patients', 'orgStudyIdInfo': {'id': 'N-20160055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'The intervention group has three steps:\n\nStep I: Titration of medicine ( 0-3 months)\n\nStep II: Telerehabilitation program at healthcare center or by call center ( 3 months)\n\nStep III: Rehabilitation in everyday life ( 6 months)\n\nThe patients is monitoring vital signs such as blood pressure, pulse, weight, steps, respiration, and sleep. Have access to a Heart Portal that is an information cite on heart failure. Via the portal patients can see measured values \\& communicate with staff. Every other week the patients fill in an online questionnaires on symptoms, sleep and well being.', 'interventionNames': ['Device: Telerehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional rehabilitation group', 'description': 'This group follows the International Cardiac Guidelines. There are three steps in this arm:\n\nStep I: Titration of medicine (3 months).\n\nStep II: Traditional rehabilitation at the healthcare center ( 3 months).\n\nStep III: Everyday life with HF ( 6 months)\n\nThe participants do not have access to the Heart Portal and is not monitoring any vital signs.'}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'DEVICE', 'description': 'Blood pressure (A\\&D Medical UA 767PBT), weight (A\\&D Medical UC-321PBT), step counters(Fitbit Zip \\& Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) \\& transmitter (Qualcomm Life, QWH-HUB-V1.0E)', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Cardiology Ward, Viborg Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Birthe Dinesen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University'}, {'name': 'Malene Hollingdal, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Jutland Regional Hospital'}, {'name': 'Jens Refsgaard, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central Jutland Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan for sharing protocol as we are applying for patent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aage og Johanne Louis-Hansens Fond', 'class': 'OTHER'}, {'name': 'Viewcare A/S', 'class': 'UNKNOWN'}, {'name': 'Laboratory of Welfare Technologies - Telehealth & Telerehabilitation, SMI, Department of Health Science and Technology, Aalborg University', 'class': 'UNKNOWN'}, {'name': 'Regionshospitalet Viborg, Skive', 'class': 'OTHER'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Danish Heart Foundation', 'class': 'OTHER'}, {'name': 'Viborg Healthcare Center', 'class': 'UNKNOWN'}, {'name': 'Skive Healthcare Center', 'class': 'UNKNOWN'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Department of Computer Science, AAU', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Birthe Dinesen', 'investigatorAffiliation': 'Aalborg University'}}}}