xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05970835</url>
    </required_header>
    <id_info>
      <org_study_id>ISAVE</org_study_id>
      <nct_id>NCT05970835</nct_id>
    </id_info>
    <brief_title>Validation of a Mobile App as an Adjuvant Treatment</brief_title>
    <acronym>VMA</acronym>
    <official_title>Validation of a Mobile App as an Adjuvant Treatment for Thermal Context Patients: a Randomized Controlled Trial Protocol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ISAVE- Instituto Superior de Saúde</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ISAVE- Instituto Superior de Saúde</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Health tourism is one of the most important touristic activities. It can generate economic&#xD;
        and social value. Balneotherapy is one of the options concerning healthcare and well-being.&#xD;
        Although this fact it lacks information concerning effectiveness of thermal water treatments.&#xD;
        Digital Technologies are being implemented and developed in health care systems, stimulated&#xD;
        also by World Health Organization (WHO), in order to facilitate and improve patients'&#xD;
        treatment and assessment. Traditional approach does not allow a follow-up due to the fact the&#xD;
        patient leaves the thermal complex after treatment or several other reasons due to that the&#xD;
        gap persists and social security of each country avoids support based on this lack of&#xD;
        information. It is important to fulfil this gap and for that digital technologies seem to be&#xD;
        the answer.&#xD;
  &#xD;
        This study aims to investigate effectiveness in self-management and clinical assessment and&#xD;
        monitorization between a smartphone app (HealthSmArt_ISAVE) and a standard approach.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a single-blinded, parallel two-arm group randomised, controlled, superiority&#xD;
        trial with a 12 months of intervention period in real thermal treatment conditions, in&#xD;
        Caldelas, Amares, Portugal. The target population will be recruited among the patients who&#xD;
        use the thermal environment in Caldelas- Amares.&#xD;
  &#xD;
        The random sequence, with a 1:1 allocation of participants in control and intervention groups&#xD;
        is going to be generated using an external website. The outcome data will be collected from&#xD;
        stored data by a research assistant who is blinded to the treatment arm.&#xD;
  &#xD;
        The study will be supported by clinicians, physiotherapists, and psychologists and will be&#xD;
        developed in ISAVE in partnership with Complexo Termal de Caldelas.&#xD;
  &#xD;
        The guideline SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials)&#xD;
        will be used for report elaboration and the manuscript will follow CONSORT (Consolidated&#xD;
        Standards for Reporting Trials) guidelines for the transparent reporting of randomized&#xD;
        trials.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Outcome assessors and data analysts will remain blinded to participant´s allocation group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Balance evaluation</measure>
      <time_frame>From baseline until the last up to 9 months</time_frame>
      <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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional ability</measure>
      <time_frame>From baseline until the last up to 9 months</time_frame>
      <description>The participant is encouraged to complete as many full stands as possible within 30 seconds.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dyspnea</measure>
      <time_frame>Through the study completion, an average 1 year</time_frame>
      <description>evaluation of dyspnea using Modified Medical Research Council (mMRC) breathlessness scale ranges from grade 0 to 4.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluate pain</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <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</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Validation</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.&#xD;
  Participants 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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control group</intervention_name>
      <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.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental group</intervention_name>
      <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.&#xD;
  After evaluation the App will display exercises related to data collected concerning participants condition improvement.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults, in treatment at Complexo Termal de Caldelas- Amares, Portugal,&#xD;
  &#xD;
            -  with chronic musculoskeletal problems&#xD;
  &#xD;
            -  respiratory issues&#xD;
  &#xD;
            -  with satisfactory cognitive analysis for exercise&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having received intramuscular or intraarticular steroid injections within 4 weeks,&#xD;
               pregnancy, moderate or severe cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea Ribeiro, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>ISAVE- CICS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Ribeiro, PhD</last_name>
      <phone>+351967441378</phone>
      <email>andrea.ribeiro@isave.pt</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mafalda Duarte, PhD</last_name>
      <phone>+351964843139</phone>
      <email>mafalda.duarte@isave.pt</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>ISAVE</name>
        <address>
          <city>Amares</city>
          <state>Braga</state>
          <zip>4720-155</zip>
          <country>Portugal</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Ribeiro, PhD</last_name>
        <phone>+351967441378</phone>
        <email>andrea.ribeiro@isave.pt</email>
      </contact>
      <contact_backup>
        <last_name>Mafalda Duarte, PhD</last_name>
        <phone>+351964843139</phone>
        <email>mafalda.duarte@isave.pt</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>thermalism</keyword>
    <keyword>tourism</keyword>
    <keyword>assessment</keyword>
    <keyword>clinical</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05970835
  org study id: ISAVE
  nct id: NCT05970835
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  
        This study aims to investigate effectiveness in self-management and clinical assessment and
        monitorization between a smartphone app (HealthSmArt_ISAVE) and a standard approach.
  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.
  
        The 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.
  
        The study will be supported by clinicians, physiotherapists, and psychologists and will be
        developed in ISAVE in partnership with Complexo Termal de Caldelas.
  
        The 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 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.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Outcome assessors and data analysts will remain blinded to participant´s allocation group.
  measure: Balance evaluation
  time frame: 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
  time frame: 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.
  measure: Dyspnea
  time frame: 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
  time frame: 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
  arm group label: Control group
  arm group type: Active Comparator
  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.
  Participants 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.
  arm group label: Experimental group
  arm group type: Experimental
  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.
  intervention type: Other
  intervention name: Control group
  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.
  arm group label: Control group
  intervention type: Other
  intervention name: Experimental group
  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.
  After evaluation the App will display exercises related to data collected concerning participants condition improvement.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrea Ribeiro, PhD
  role: Principal Investigator
  affiliation: ISAVE- CICS
  last name: Andrea Ribeiro, PhD
  phone: +351967441378
  email: andrea.ribeiro@isave.pt
  last name: Mafalda Duarte, PhD
  phone: +351964843139
  email: mafalda.duarte@isave.pt
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Portugal
  responsible party type: Sponsor
  sharing ipd: No