Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:46 PM
Study NCT ID:
NCT05011994
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2021-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance of Physical Activity After Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2021-07-17', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health-related quality of life, general', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.'}, {'measure': 'Health-related quality of life, VAS subscale', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'EQ-5D-5L evaluates health status in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated from 1 (best) to 5 (worst) and overall health is rated on a 0 to 100 VAS scale.'}, {'measure': 'Health-related quality of life, heart-specific', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'HeartQoL is used to measure heart-specific quality of life in the past 4 weeks. Range from 0 (worst) to 42 (best) .'}, {'measure': 'Anxiety and depression', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Hospital Anxiety and Depression Scale (HADS). HADS gives a score for each of anxiety and depression, each ranging from 0 (best) to 21 (worst).'}, {'measure': 'Physical function, self-reported', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'WHO Disability Assessment Schedule 2.0 (WHODAS 2.0),12-item version. WHODAS is a generic assessment instrument for health and disability. Range from 12 (no disability) to 60 (highest disability or loss of function).'}, {'measure': 'Comorbidity', 'timeFrame': 'Change from baseline to 12 weeks', 'description': "Disease Burden: Morbidity Assessment by Self-Report used to evaluated a list of common chronic conditions affect the participants' daily activities. Each condition (that the participant has) is rated from 1 (not at all) to 5 (a lot) in regard to how much it limits daily activities."}, {'measure': 'Self-efficacy, managing chronic disease', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Self-efficacy of managing chronic disease 6 items scale. Score is calculated as the mean of 6 items, each scored from 1 (low self-efficacy) to 10 (high self-efficacy).'}, {'measure': 'Motivational Self-efficacy', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Motivational self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).'}, {'measure': 'Coping Self-efficacy', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Coping self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).'}, {'measure': 'Recovery Self-efficacy', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Recovery self-efficacy, HAPA items by Schwartzer R., 2 items each rated on a scale from 1 (low self-efficacy) to 4 (high self-efficacy).'}], 'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'Baseline', 'description': 'Green: Mean of ≥0.75 recruited participants per week per site\n\nAmber: Mean of 0.5-0.74 recruited participants per week per site\n\nRed: Mean of \\<0.5 recruited participants per week per site'}, {'measure': 'Attrition/retention through follow-up assessment session', 'timeFrame': 'Up to 12 weeks', 'description': 'Green: ≥80% retention of participants through follow up\n\nAmber: 50-79% retention of participants through follow up\n\nRed: \\<50% retention of participants through follow up'}, {'measure': 'Accelerometer data completeness', 'timeFrame': 'Baseline', 'description': 'Green: Accelerometer data from both baseline and follow-up available on ≥80% of completing participants\n\nAmber: Data available on 50-79% of completing participants\n\nRed: Data available on \\<50% of completing participants'}, {'measure': 'Accelerometer data completeness', 'timeFrame': '12 weeks', 'description': 'Green: Accelerometer data from both baseline and follow-up available on ≥80% of completing participants\n\nAmber: Data available on 50-79% of completing participants\n\nRed: Data available on \\<50% of completing participants'}, {'measure': 'Response rate on patient reported outcomes', 'timeFrame': 'Baseline', 'description': 'Green: ≥90% of participants attending baseline and follow-up assessment return patient reported outcomes\n\nAmber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes\n\nRed: \\<75% of participants attending baseline and follow-up assessment return patient reported outcomes'}, {'measure': 'Response rate on patient reported outcomes', 'timeFrame': '12 weeks', 'description': 'Green: ≥90% of participants attending baseline and follow-up assessment return patient reported outcomes\n\nAmber: 75-89% of patients attending baseline and follow-up assessment return patient reported outcomes\n\nRed: \\<75% of participants attending baseline and follow-up assessment return patient reported outcomes'}, {'measure': 'Coordinator time spent, minutes per participant throughout the intervention', 'timeFrame': '12 weeks', 'description': 'Green: Mean coordinator time spent of ≤30 minutes per participant\n\nAmber: Mean coordinator time spent of 31-60 minutes per participant\n\nRed: Mean coordinator time spent of \\>60 minutes per participant'}, {'measure': 'Response rate (adherence) to weekly follow-up messages', 'timeFrame': '12 weeks', 'description': 'Green: ≥75% of patients respond to at least 75% of messages\n\nAmber: 50-74% of patients respond to at least 75% of messages\n\nRed: \\<50% of patients respond to at least 75% of messages'}, {'measure': 'Acceptability of text message component, single item', 'timeFrame': '12 weeks', 'description': 'Green: ≥75% of participants find text messages acceptable\n\nAmber: 50-74% of participants find text messages acceptable\n\nRed: \\<50% of participants find text messages acceptable'}], 'secondaryOutcomes': [{'measure': 'Physical activity, objectively measured', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'Measured with thigh and wrist accelerometers'}, {'measure': 'Physical function, walking', 'timeFrame': 'Change from baseline to 12 weeks', 'description': '6 minute walking test'}, {'measure': 'Physical function, sit-to-stand', 'timeFrame': 'Change from baseline to 12 weeks', 'description': '30-second sit-to-stand test'}, {'measure': 'Physical activity, subjectively measured', 'timeFrame': 'Change from baseline to 12 weeks', 'description': 'The International Physical Activity Questionnaire (IPAQ) is used to measure physical activity in the past 7 days. 0 is minimum (completely inactivty).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac rehabilitation', 'ischemic heart disease'], 'conditions': ['Cardiovascular Diseases', 'Heart Diseases', 'Myocardial Ischemia', 'Heart Failure', 'Arrythmia', 'Heart Arrest']}, 'referencesModule': {'references': [{'pmid': '35383088', 'type': 'DERIVED', 'citation': 'Andersen RM, Skou ST, Clausen MB, Jager M, Zangger G, Grontved A, Brond JC, Soja AMB, Tang LH. Maintenance of physical activity after cardiac rehabilitation (FAIR): study protocol for a feasibility trial. BMJ Open. 2022 Apr 5;12(4):e060157. doi: 10.1136/bmjopen-2021-060157.'}], 'seeAlsoLinks': [{'url': 'https://bmjopen.bmj.com/content/12/4/e060157.info', 'label': 'Link to published study protocol'}]}, 'descriptionModule': {'briefSummary': 'Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines. The aim of this study is to evaluate the feasibility a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program. An intervention consisting of action planning, text messages, and coordinator support is tested in a feasibility trial design with 40 expected participants.', 'detailedDescription': "Physical activity is a key element in cardiac rehabilitation and prevention of cardiovascular mortality and hospitalizations. After cardiac rehabilitation programs end, physical activity levels and participation in continued cardiac rehabilitation declines.\n\nThe primary aim of this study is to evaluate the feasibility in terms of recruitment, retention, data completeness, intervention delivery and compliance, and acceptability of a mobile health intervention with text messages and behavior change theory in patients with cardiovascular disease for a duration of 3 months after completion of a cardiac rehabilitation program.\n\nThe study is a single-group multi-site feasibility trial. Participants will be recruited from phase II cardiac rehabilitation programs at Slagelse Hospital, the city of Slagelse (municipality), and Holbæk Hospital. Starting immediately after completion of cardiac rehabilitation, study participants will receive an intervention that consists of action planning, text messages, and coordinator support for a period of 12 weeks (see more details under 'Arms and Interventions'). The investigators base the intervention on a theoretical model of behavior change in the form of the Health Action Process Approach (HAPA). Behavior change techniques (BCTs) are used as part of the intervention. The intervention is an addition to standard practice and does not replace any existing treatment offers.\n\nTo evaluate the feasibility of the intervention and its readiness to be tested in a subsequent RCT design, the investigators have set progression criteria using a system of green (proceed to RCT), amber (amend when proceeding to RCT), or red (issue must be solved before proceeding to RCT). The progression criteria are listed under 'Primary Outcome Measures'.\n\nParticipants will wear accelerometers on thigh and wrist for 1 and 3 weeks, respectively, starting 1 week before end of cardiac rehabilitation. Baseline measurements and start of intervention is planned to be at the same time as cardiac rehabilitation ends. After 11 weeks of intervention, participants will attend a follow-up assessment, where participants will wear accelerometers on thigh and wrist again."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Participant in an exercise-based cardiac rehabilitation program in either hospital or municipality setting.\n* Access to a personal mobile phone and Danish telephone number.\n* Able to walk 3 meters without assistance.\n\nExclusion Criteria:\n\n* Insufficient Danish language proficiency to read and understand text messages and questionnaires.\n* Patients cognitively or mentally unable to participate.\n* Terminal patients and patients with a life expectancy of less than 3 months.'}, 'identificationModule': {'nctId': 'NCT05011994', 'acronym': 'FAIR', 'briefTitle': 'Maintenance of Physical Activity After Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Slagelse Hospital'}, 'officialTitle': 'Maintenance of Physical Activity After Cardiac Rehabilitation: a Feasibility Trial', 'orgStudyIdInfo': {'id': 'EMN-2021-00020'}, 'secondaryIdInfos': [{'id': 'EMN-2021-00020', 'type': 'OTHER', 'domain': 'Research Ethics Committee of Region Zealand, Denmark'}, {'id': 'REG-162-2020', 'type': 'OTHER', 'domain': 'Danish Data Protection Agency through Region Zealand'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maintenance intervention', 'description': 'Participants will receive a 12-week mobile health (mHealth) intervention that consists of action planning, text messages, and coordinator support.', 'interventionNames': ['Behavioral: Maintenance intervention']}], 'interventions': [{'name': 'Maintenance intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of action planning, text messages, and coordinator support.\n\nAt onset, each participant creates an action plan for physical activity with the help of a health professional:\n\n* What types of physical activities?\n* When and how often?\n* Where and with who?\n\n 2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted.\n\nParticipants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions:\n\n* Call participants replying to texts that they wish to be contacted\n* Help participants establish contact to local activities involving physical activity\n* Follow-up on and adjustment of action plan\n* Offer guidance in physical activity', 'armGroupLabels': ['Maintenance intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4300', 'city': 'Holbæk', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Holbæk Hospital', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '4220', 'city': 'Korsør', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'City of Slagelse (municipality)', 'geoPoint': {'lat': 55.32993, 'lon': 11.13857}}, {'zip': '4200', 'city': 'Slagelse', 'status': 'RECRUITING', 'country': 'Denmark', 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'centralContacts': [{'name': 'Rune M Andersen, PhD', 'role': 'CONTACT', 'email': 'ruma@regionsjaelland.dk', 'phone': '+4529623522', 'phoneExt': '+4558559790'}, {'name': 'Lars H Tang, PhD', 'role': 'CONTACT', 'email': 'larta@regionsjaelland.dk', 'phone': '+4558559790'}], 'overallOfficials': [{'name': 'Rune M Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark'}, {'name': 'Lars H Tang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark'}, {'name': 'Søren T Skou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Næstved-Slagelse-Ringsted Hospitals; University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slagelse Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'City of Slagelse (municipality)', 'class': 'UNKNOWN'}, {'name': 'Holbaek Sygehus', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}, {'name': 'University College Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}