Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT05970835
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Mobile App as an Adjuvant Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors and data analysts will remain blinded to participant´s allocation group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a single-blinded, parallel two-arm group randomised, controlled, superiority trial with a 3 months of intervention period in real thermal treatment conditions, in Caldelas- Amares, Portugal. The target population will be recruited among the patients who use the thermal environment in Caldelas- Amares.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-30', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-30', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance evaluation', 'timeFrame': 'From baseline until the last up to 9 months', 'description': 'Balance will be evaluated using Berg Balance Scale, composed by 14 items, Item-level scores range from 0-4, determined by ability to perform the assessed activity, Item scores are then summed, Maximum score = 56'}, {'measure': 'Functional ability', 'timeFrame': 'From baseline until the last up to 9 months', 'description': 'The participant is encouraged to complete as many full stands as possible within 30 seconds.'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'Through the study completion, an average 1 year', 'description': 'evaluation of dyspnea using Modified Medical Research Council (mMRC) breathlessness scale ranges from grade 0 to 4.'}, {'measure': 'Evaluate pain', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'evaluation of pain and morning stiffness, using visual analog scale, considering 1 the lowest pain ever felt and 10 the worst pain ever felt'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thermalism', 'tourism', 'assessment', 'clinical'], 'conditions': ['Validation']}, 'descriptionModule': {'briefSummary': "Health tourism is one of the most important touristic activities. It can generate economic and social value. Balneotherapy is one of the options concerning healthcare and well-being. Although this fact it lacks information concerning effectiveness of thermal water treatments. Digital Technologies are being implemented and developed in health care systems, stimulated also by World Health Organization (WHO), in order to facilitate and improve patients' treatment and assessment. Traditional approach does not allow a follow-up due to the fact the patient leaves the thermal complex after treatment or several other reasons due to that the gap persists and social security of each country avoids support based on this lack of information. It is important to fulfil this gap and for that digital technologies seem to be the answer.\n\nThis study aims to investigate effectiveness in self-management and clinical assessment and monitorization between a smartphone app (HealthSmArt\\_ISAVE) and a standard approach.", 'detailedDescription': 'This will be a single-blinded, parallel two-arm group randomised, controlled, superiority trial with a 12 months of intervention period in real thermal treatment conditions, in Caldelas, Amares, Portugal. The target population will be recruited among the patients who use the thermal environment in Caldelas- Amares.\n\nThe random sequence, with a 1:1 allocation of participants in control and intervention groups is going to be generated using an external website. The outcome data will be collected from stored data by a research assistant who is blinded to the treatment arm.\n\nThe study will be supported by clinicians, physiotherapists, and psychologists and will be developed in ISAVE in partnership with Complexo Termal de Caldelas.\n\nThe guideline SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) will be used for report elaboration and the manuscript will follow CONSORT (Consolidated Standards for Reporting Trials) guidelines for the transparent reporting of randomized trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, in treatment at Complexo Termal de Caldelas- Amares, Portugal,\n* with chronic musculoskeletal problems\n* respiratory issues\n* with satisfactory cognitive analysis for exercise\n\nExclusion Criteria:\n\n* having received intramuscular or intraarticular steroid injections within 4 weeks, pregnancy, moderate or severe cognitive impairment'}, 'identificationModule': {'nctId': 'NCT05970835', 'acronym': 'VMA', 'briefTitle': 'Validation of a Mobile App as an Adjuvant Treatment', 'organization': {'class': 'OTHER', 'fullName': 'ISAVE- Instituto Superior de Saúde'}, 'officialTitle': 'Validation of a Mobile App as an Adjuvant Treatment for Thermal Context Patients: a Randomized Controlled Trial Protocol', 'orgStudyIdInfo': {'id': 'ISAVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': "Firstly, all patients will be evaluated using Physical Performance Test, Saint George's Respiratory Questionnaire , and Geriatric Pain Measure and the MiniMental Satet Exam to fulfill the eligibility criteria. After that participants will be randomly assigned using the software www.randomizer.org. to control or intervention group. Outcome assessors and data analysts will remain blinded to participant´s allocation group.\n\nParticipants assigned to control group will receive the usual care provided by clinicians and physiotherapists from the Complexo Termal de Caldelas. They will have an educational session conducted by one of the researchers, and a paper sheet will be distributed with exercises and a written explanation of how to perform those exercises and the number of sets and repetitions.", 'interventionNames': ['Other: Control group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Concerning patients from the intervention group will have an educational session given by one of the researchers, explaining how to use the HealthSmArt\\_ISAVE App. Then each patient will be given a unique code and password to log into the App and to start working with their smartphones. HealthSmArt\\_ISAVE App has three main components which are: evaluation (short, medium and long term); screening and intervention/rehabilitation.', 'interventionNames': ['Other: Experimental group']}], 'interventions': [{'name': 'Control group', 'type': 'OTHER', 'description': 'Participants assigned to control group will receive the usual care provided by clinicians and physiotherapists from the Complexo Termal de Caldelas. Participants will have an educational session conducted by one of the researchers, and a paper sheet will be distributed with exercises and a written explanation of how to perform those exercises and the number of sets and repetitions. data collection will be conducted in moments t2 and t3 by a phone call.', 'armGroupLabels': ['Control group']}, {'name': 'Experimental group', 'type': 'OTHER', 'description': 'Experimental group evaluation: balance, functionality- 30 Second Sit To Stand Test, Modified Medical Research Council and functional status questionnaire, pain using VAS, cognitive variables-Montreal Cognitive Assessment and self-reported thermal water effects.After evaluation the App will display exercises related to data collected. Outcome measures will be collected at baseline, and 1 week, 1 month and 3 months after baseline.\n\nAfter evaluation the App will display exercises related to data collected concerning participants condition improvement.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4720-155', 'city': 'Amares', 'state': 'Braga District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Andrea Ribeiro, PhD', 'role': 'CONTACT', 'email': 'andrea.ribeiro@isave.pt', 'phone': '+351967441378'}, {'name': 'Mafalda Duarte, PhD', 'role': 'CONTACT', 'email': 'mafalda.duarte@isave.pt', 'phone': '+351964843139'}], 'facility': 'ISAVE', 'geoPoint': {'lat': 41.63091, 'lon': -8.35117}}], 'centralContacts': [{'name': 'Andrea Ribeiro, PhD', 'role': 'CONTACT', 'email': 'andrea.ribeiro@isave.pt', 'phone': '+351967441378'}, {'name': 'Mafalda Duarte, PhD', 'role': 'CONTACT', 'email': 'mafalda.duarte@isave.pt', 'phone': '+351964843139'}], 'overallOfficials': [{'name': 'Andrea Ribeiro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ISAVE- CICS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ISAVE- Instituto Superior de Saúde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}