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/NCT05967247</url>
    </required_header>
    <id_info>
      <org_study_id>202307171RINA</org_study_id>
      <nct_id>NCT05967247</nct_id>
    </id_info>
    <brief_title>MBSR on Physiological and Psychological Factors in Patients With HF</brief_title>
    <acronym>MBSR-PP-HF</acronym>
    <official_title>The Effect of App-Based Mindfulness-Based Stress on Physiological and Psychological Factors in Patients With Heart Failure: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        Objective&#xD;
  &#xD;
        The purpose of this study is to explore the relationship between mindfulness, resilience,&#xD;
        depression and quality of life in patients with heart failure, and the effect of&#xD;
        mindfulness-based stress reduction intervention with mobile phone application on subjects&#xD;
        with depressive symptoms. Therefore, the research objectives are as follows:&#xD;
  &#xD;
          1. To explore the relationship between mindfulness, resilience, depression, and quality of&#xD;
             life in patients with heart failure, and to explore the mediating role of positive&#xD;
             emotions (mindfulness, resilience).&#xD;
  &#xD;
          2. Using a mobile phone app to conduct mindfulness-based stress reduction interventions, to&#xD;
             explore the effects of physiological and psychological factors in heart failure patients&#xD;
             with depressive symptoms.&#xD;
  &#xD;
        Methods This study will be conducted in two parts. The first part will be a cross-sectional&#xD;
        study. It is planned to be conducted in the cardiology ward or outpatient clinic of a&#xD;
        university-affiliated hospital in northern Taiwan between September and December 2023 after&#xD;
        the approval of the Human Experiment Ethics Committee. Contact the patients who meet the&#xD;
        research conditions, adopt the intentional sampling method, and plan to accept 180 research&#xD;
        objects for the questionnaire survey, the collection tools are the basic information of the&#xD;
        research objects, mindfulness, resilience, depression, quality of life scale; in the first&#xD;
        part, the patients' Health Questionnaire (patient health questionnaire-9, PHQ-9) was used to&#xD;
        screen for depressive symptoms, and when the total score ≧ 5 points, they were invited to&#xD;
        participate in the second part of the study. The second part plans to include 68 subjects in&#xD;
        the study, adopting a single-blind random allocation waiting list design, using the app&#xD;
        designed by the researcher to implement the mindfulness-based stress reduction intervention&#xD;
        program, which is planned to be carried out for 8 weeks, and since the beginning of the&#xD;
        study, the 8th week (After the intervention in the experimental group), and the 16th week&#xD;
        (after the intervention in the control group), a total of three research data collections&#xD;
        were carried out.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Expected research results The expected results of the first part of the research are that the&#xD;
        research subjects with higher mindfulness have less depression, higher resilience, and better&#xD;
        quality of life, and the mindfulness of the research subjects can play a mediating role&#xD;
        between depression and quality of life; the second part expects the research subjects After&#xD;
        receiving the intervention of mindfulness-based stress reduction on the mobile phone&#xD;
        application, it can increase their mindfulness, resilience and quality of life, reduce&#xD;
        depression, blood pressure, and improve heart rate variability.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Difficult to blind study caregivers and study outcome assessors due to the nature of the mindfulness-based stress reduction intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>quality of life (SF-12v2）</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>short-form health survey (SF-12v2）, Cronbach's α = 0.76～0.85.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>depression</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>patient health questionnaire (PHQ-9）, Cronbach's α = 0.84</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mindfulness</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>five facet mindfulness questionnaire-short form (FFMQ-SF）, Cronbach's α= 0.69～0.85.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resilience</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>Connor-Davidson resilience scale (CD-RISC-10）, Cronbach's α = 0.94</description>
    </secondary_outcome>
    <other_outcome>
      <measure>medication adherence</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>Medication Adherence Self-Reported by Patient</description>
    </other_outcome>
    <other_outcome>
      <measure>Heart rate variability (HRV)</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>Measured with a non-plunging wrist-worn instrument</description>
    </other_outcome>
    <other_outcome>
      <measure>heart rate (pulse)</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>Measured according to the blood pressure measuring instrument regularly calibrated by the hospital</description>
    </other_outcome>
    <other_outcome>
      <measure>blood pressure (BP)</measure>
      <time_frame>T0, T1 = 8 weeks, T2 = 16 weeks.</time_frame>
      <description>Measured according to the blood pressure measuring instrument regularly calibrated by the hospital</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>MBSR</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group used App for MBSR intervention The main app of this experiment is &quot;Mindfulness in life (Taiwan)&quot; (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practising audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>waiting list</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The waiting list used only the Heart Care Life app for the first eight weeks, as self-management is an essential element of heart failure treatment (Tsami et al., 2023), following the situation-specific theory of heart failure self-management (the situation- specific theory of heart failure self-care:) (Riegel et al., 2022) and American heart failure guidelines (Heidenreich et al., 2022) design (Tsami et al., 2023; Vellone et al., 2020), mainly for Disease-related knowledge and self-management tools, built-in disease health education electronic audiobooks, diet sodium content calculator, diet water content calculator, activity step calculation, etc., to help research subjects self-manage the disease.&#xD;
  Measure T2 at week 8. From the ninth to the sixteenth week, use the Mindful Live app.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The experimental group used App for MBSR intervention</intervention_name>
      <description>The experimental group used App for MBSR intervention The main app of this experiment is &quot;Mindfulness in Life (Taiwan)&quot; (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practicing audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.</description>
      <arm_group_label>MBSR</arm_group_label>
      <other_name>Control group serves as a waiting list with priority given to placebo Placebo for the &quot;Heart Care Life&quot; app.</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>the &quot;Heart Care Life&quot; app</intervention_name>
      <description>Control group serves as a waiting list with priority given to placebo Placebo for the &quot;Heart Care Life&quot; app.</description>
      <arm_group_label>MBSR</arm_group_label>
      <arm_group_label>waiting list</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Phone interview once a week</intervention_name>
      <description>Phone interview once a week</description>
      <arm_group_label>MBSR</arm_group_label>
      <arm_group_label>waiting list</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          1. Inclusion Criteria:&#xD;
  &#xD;
                 -  (1) The diagnosis of heart failure is confirmed by a clinician, and the&#xD;
                    definition of the diagnosis is based on the international statistical&#xD;
                    classification of diseases and related health problems 10th revision (ICD-10),&#xD;
                    including I50 Heart failure ( heart failure) related diagnostic codes.&#xD;
  &#xD;
                 -  (2) Legally recognized as an adult ≧ 18 years old.&#xD;
  &#xD;
                 -  (3) The second part of the experimental research, in addition to the above&#xD;
                    inclusion conditions, also needs to have a patient health questionnaire ≥ 5&#xD;
                    points, which means mild or above (including) depression (Kroenke et al., 2001;&#xD;
                    Yeung et al., 2008) can be included in the study.&#xD;
  &#xD;
            2. Exclusion Criteria:&#xD;
  &#xD;
                 -  (1) Diagnosed by a physician as having depression or taking antidepressant drugs&#xD;
                    regularly, such as selective serotonin reuptake inhibitor (SSRI), serotonin and&#xD;
                    norepinephrine reuptake inhibitor (serotonin-norepinephrine reuptake inhibitors&#xD;
                    (SNRI), tricyclic antidepressants (TCA), monoamine oxidase inhibitors (monoamine&#xD;
                    oxidase inhibitor, MAOI), tetracyclic antidepressants (TeCA), norepinephrine And&#xD;
                    specific serotonergic antidepressants (Noradrenergic and specific serotonergic&#xD;
                    antidepressants, NaSSA).&#xD;
  &#xD;
                 -  (2) New York heart association functional classification (NYHA Fc) IV, which&#xD;
                    means that it is uncomfortable to perform any physical activity, even when lying&#xD;
                    in bed or moving, you may feel symptoms such as dyspnea or palpitations.&#xD;
  &#xD;
                 -  (3) Those who still need to use oxygen or breathing aids throughout the day.&#xD;
  &#xD;
                 -  (4) Those who are still equipped with ventricular assist devices and rely on&#xD;
                    life-support devices.&#xD;
  &#xD;
                 -  (5) Activities of daily living (ADL) &lt; 60 points, unable to take care of&#xD;
                    themselves in daily life.&#xD;
  &#xD;
                 -  (6) For those with abnormal cognitive function, the mini-mental state examination&#xD;
                    (MMSE) &lt; 24 points.&#xD;
  &#xD;
                 -  (7) Those who have undergone heart transplantation have lost innervation because&#xD;
                    there is no connection between the autonomic nerve and the heart (McCraty &amp;&#xD;
                    Shaffer, 2015).&#xD;
  &#xD;
                 -  (8) In the second part of the interventional experimental research, in addition&#xD;
                    to the above exclusion conditions, in order to avoid interference with the&#xD;
                    research, it is also necessary to exclude:&#xD;
  &#xD;
                 -  A. Those who cannot read traditional Chinese or communicate in Mandarin or&#xD;
                    Taiwanese, because health education-related materials, videos and applications&#xD;
                    are all in traditional Chinese.&#xD;
  &#xD;
                 -  B. Those who cannot use Android devices at home with smartphones or tablets need&#xD;
                    to operate the application at home due to intervention measures.&#xD;
  &#xD;
                 -  C. Those who have regularly taken measures related to mindfulness, meditation,&#xD;
                    and sitting meditation in the past year are not included in order to avoid&#xD;
                    interfering with the research results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shu-Ling Wang, RN</last_name>
      <phone>+886223123456</phone>
      <phone_ext>263205</phone_ext>
      <email>cryetaljessie@ntuh.gov.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100225</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <contact>
        <last_name>Shu-Ling Wang, RN</last_name>
        <phone>+866223123456</phone>
        <phone_ext>263205</phone_ext>
        <email>crystaljessie@ntuh.gov.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <link>
      <url>https://orcid.org/0000-0002-0678-2264</url>
      <description>Chih-fan Yeh</description>
    </link>
    <link>
      <url>https://orcid.org/0000-0002-1062-8307</url>
      <description>Chia-Jung Hsieh</description>
    </link>
    <link>
      <url>https://orcid.org/0000-0002-4336-765X</url>
      <description>Shu-Ling Wang</description>
    </link>
    <reference>
      <citation>MIT (2012). APP Inventor. Massachusetts Institute of Technology. United States. https://appinventor.mit.edu/</citation>
    </reference>
    <reference>
      <citation>Edhouse J, Wardrope J, Morris FP. Call to needle times after acute myocardial infarction. Delay in calling for help for chest pain. BMJ. 1999 Feb 27;318(7183):597; author reply 598. No abstract available. Erratum In: BMJ 1999 Jun 12;318(7198):1584.</citation>
      <PMID>10037647</PMID>
    </reference>
    <reference>
      <citation>Riegel B, Dickson VV, Vellone E. The Situation-Specific Theory of Heart Failure Self-care: An Update on the Problem, Person, and Environmental Factors Influencing Heart Failure Self-care. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):515-529. doi: 10.1097/JCN.0000000000000919. Epub 2022 Apr 27.</citation>
      <PMID>35482335</PMID>
    </reference>
    <reference>
      <citation>Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551.</citation>
      <PMID>35379503</PMID>
    </reference>
    <reference>
      <citation>McCraty R, Shaffer F. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk. Glob Adv Health Med. 2015 Jan;4(1):46-61. doi: 10.7453/gahmj.2014.073.</citation>
      <PMID>25694852</PMID>
    </reference>
    <reference>
      <citation>Vandenbogaart E, Gawlinski A, Grimley KA, Lewis MA, Pavlish C. App-Based Mindfulness Intervention to Improve Psychological Outcomes in Pretransplant Patients With Heart Failure. Crit Care Nurse. 2023 Apr 1;43(2):15-25. doi: 10.4037/ccn2023411.</citation>
      <PMID>37001879</PMID>
    </reference>
    <reference>
      <citation>Tabernero C, Gutierrez-Domingo T, Steca P, Castillo-Mayen R, Cuadrado E, Rubio SJ, Farhane-Medina NZ, Luque B. Effectiveness of Mindfulness and Positive Strengthening mHealth Interventions for the Promotion of Subjective Emotional Wellbeing and Management of Self-Efficacy for Chronic Cardiac Diseases. J Pers Med. 2022 Nov 25;12(12):1953. doi: 10.3390/jpm12121953.</citation>
      <PMID>36556174</PMID>
    </reference>
    <reference>
      <citation>MacEwen EG, Brown NO, Patnaik AK, Hayes AA, Passe S. Cyclic combination chemotherapy of canine lymphosarcoma. J Am Vet Med Assoc. 1981 Jun 1;178(11):1178-81. No abstract available.</citation>
      <PMID>6895078</PMID>
    </reference>
    <reference>
      <citation>Heo S, McSweeney J, Ounpraseuth S, Shaw-Devine A, Fier A, Moser DK. Testing a Holistic Meditation Intervention to Address Psychosocial Distress in Patients With Heart Failure: A Pilot Study. J Cardiovasc Nurs. 2018 Mar/Apr;33(2):126-134. doi: 10.1097/JCN.0000000000000435.</citation>
      <PMID>28661991</PMID>
    </reference>
    <reference>
      <citation>Curtis PJ. Globin mRNA in Friend cells: its structure, function and synthesis. Biochim Biophys Acta. 1980 Sep 22;605(3):347-64. doi: 10.1016/0304-419x(80)90016-5.</citation>
      <PMID>6996728</PMID>
    </reference>
    <reference>
      <citation>Simas W, Chiossi JC, Abib OA. [Urethral prolapse in a young woman]. Rev Paul Med. 1972 Aug;80(2):83-6. No abstract available. Portuguese.</citation>
      <PMID>4671576</PMID>
    </reference>
    <reference>
      <citation>Kang Q, Luo A. The efficacy of mindfulness-based intervention for heart diseases: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2022 Sep 30;101(39):e29649. doi: 10.1097/MD.0000000000029649.</citation>
      <PMID>36181030</PMID>
    </reference>
    <reference>
      <citation>Jalali D, Abdolazimi M, Alaei Z, Solati K. Effectiveness of mindfulness-based stress reduction program on quality of life in cardiovascular disease patients. Int J Cardiol Heart Vasc. 2019 Apr 12;23:100356. doi: 10.1016/j.ijcha.2019.100356. eCollection 2019 Jun.</citation>
      <PMID>31011624</PMID>
    </reference>
    <reference>
      <citation>Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567.</citation>
      <PMID>31573916</PMID>
    </reference>
    <reference>
      <citation>Felsted KF. Mindfulness, Stress, and Aging. Clin Geriatr Med. 2020 Nov;36(4):685-696. doi: 10.1016/j.cger.2020.06.010. Epub 2020 Aug 17.</citation>
      <PMID>33010903</PMID>
    </reference>
    <reference>
      <citation>Kabat-Zinn, J., &amp; Hanh, T. N. (2009). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta.</citation>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 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>Mindfulness-based stress reduction</keyword>
    <keyword>Application</keyword>
    <keyword>Resilience</keyword>
    <keyword>Heart failure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05967247
  org study id: 202307171RINA
  nct id: NCT05967247
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objective
  
        The purpose of this study is to explore the relationship between mindfulness, resilience,
        depression and quality of life in patients with heart failure, and the effect of
        mindfulness-based stress reduction intervention with mobile phone application on subjects
        with depressive symptoms. Therefore, the research objectives are as follows:
  
          1. To explore the relationship between mindfulness, resilience, depression, and quality of
             life in patients with heart failure, and to explore the mediating role of positive
             emotions (mindfulness, resilience).
  
          2. Using a mobile phone app to conduct mindfulness-based stress reduction interventions, to
             explore the effects of physiological and psychological factors in heart failure patients
             with depressive symptoms.
  
        Methods This study will be conducted in two parts. The first part will be a cross-sectional
        study. It is planned to be conducted in the cardiology ward or outpatient clinic of a
        university-affiliated hospital in northern Taiwan between September and December 2023 after
        the approval of the Human Experiment Ethics Committee. Contact the patients who meet the
        research conditions, adopt the intentional sampling method, and plan to accept 180 research
        objects for the questionnaire survey, the collection tools are the basic information of the
        research objects, mindfulness, resilience, depression, quality of life scale; in the first
        part, the patients' Health Questionnaire (patient health questionnaire-9, PHQ-9) was used to
        screen for depressive symptoms, and when the total score ≧ 5 points, they were invited to
        participate in the second part of the study. The second part plans to include 68 subjects in
        the study, adopting a single-blind random allocation waiting list design, using the app
        designed by the researcher to implement the mindfulness-based stress reduction intervention
        program, which is planned to be carried out for 8 weeks, and since the beginning of the
        study, the 8th week (After the intervention in the experimental group), and the 16th week
        (after the intervention in the control group), a total of three research data collections
        were carried out.
  Expected research results The expected results of the first part of the research are that the
        research subjects with higher mindfulness have less depression, higher resilience, and better
        quality of life, and the mindfulness of the research subjects can play a mediating role
        between depression and quality of life; the second part expects the research subjects After
        receiving the intervention of mindfulness-based stress reduction on the mobile phone
        application, it can increase their mindfulness, resilience and quality of life, reduce
        depression, blood pressure, and improve heart rate variability.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Other
  masking: Single (Participant)
  masking description: Difficult to blind study caregivers and study outcome assessors due to the nature of the mindfulness-based stress reduction intervention
  measure: quality of life (SF-12v2）
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: short-form health survey (SF-12v2）, Cronbach's α = 0.76～0.85.
  measure: depression
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: patient health questionnaire (PHQ-9）, Cronbach's α = 0.84
  measure: mindfulness
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: five facet mindfulness questionnaire-short form (FFMQ-SF）, Cronbach's α= 0.69～0.85.
  measure: Resilience
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: Connor-Davidson resilience scale (CD-RISC-10）, Cronbach's α = 0.94
  measure: medication adherence
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: Medication Adherence Self-Reported by Patient
  measure: Heart rate variability (HRV)
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: Measured with a non-plunging wrist-worn instrument
  measure: heart rate (pulse)
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: Measured according to the blood pressure measuring instrument regularly calibrated by the hospital
  measure: blood pressure (BP)
  time frame: T0, T1 = 8 weeks, T2 = 16 weeks.
  description: Measured according to the blood pressure measuring instrument regularly calibrated by the hospital
  arm group label: MBSR
  arm group type: Experimental
  description: The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practising audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.
  arm group label: waiting list
  arm group type: Placebo Comparator
  description: The waiting list used only the Heart Care Life app for the first eight weeks, as self-management is an essential element of heart failure treatment (Tsami et al., 2023), following the situation-specific theory of heart failure self-management (the situation- specific theory of heart failure self-care:) (Riegel et al., 2022) and American heart failure guidelines (Heidenreich et al., 2022) design (Tsami et al., 2023; Vellone et al., 2020), mainly for Disease-related knowledge and self-management tools, built-in disease health education electronic audiobooks, diet sodium content calculator, diet water content calculator, activity step calculation, etc., to help research subjects self-manage the disease.
  Measure T2 at week 8. From the ninth to the sixteenth week, use the Mindful Live app.
  intervention type: Other
  intervention name: The experimental group used App for MBSR intervention
  description: The experimental group used App for MBSR intervention The main app of this experiment is "Mindfulness in Life (Taiwan)" (this system is only applicable to Android devices). The content is divided into two parts. The course is compressed and simplified, mainly focusing on mindfulness learning and practicing audio-visuals. There are eight-week themed audio-visuals and mindful caring words guided by mindfulness-based stress reduction, mindfulness-stretching guidance, and the function of recording the reading time of the research subjects. App platform for researchers to communicate.
  arm group label: MBSR
  other name: Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.
  intervention type: Other
  intervention name: the "Heart Care Life" app
  description: Control group serves as a waiting list with priority given to placebo Placebo for the "Heart Care Life" app.
  arm group label: MBSR
  arm group label: waiting list
  intervention type: Other
  intervention name: Phone interview once a week
  description: Phone interview once a week
  arm group label: MBSR
  arm group label: waiting list
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shu-Ling Wang, RN
  phone: +886223123456
  phone ext: 263205
  email: cryetaljessie@ntuh.gov.tw
  facility: 
  contact: 
  country: Taiwan
  url: https://orcid.org/0000-0002-0678-2264
  description: Chih-fan Yeh
  url: https://orcid.org/0000-0002-1062-8307
  description: Chia-Jung Hsieh
  url: https://orcid.org/0000-0002-4336-765X
  description: Shu-Ling Wang
  citation: MIT (2012). APP Inventor. Massachusetts Institute of Technology. United States. https://appinventor.mit.edu/
  citation: Edhouse J, Wardrope J, Morris FP. Call to needle times after acute myocardial infarction. Delay in calling for help for chest pain. BMJ. 1999 Feb 27;318(7183):597; author reply 598. No abstract available. Erratum In: BMJ 1999 Jun 12;318(7198):1584.
  PMID: 10037647
  citation: Riegel B, Dickson VV, Vellone E. The Situation-Specific Theory of Heart Failure Self-care: An Update on the Problem, Person, and Environmental Factors Influencing Heart Failure Self-care. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):515-529. doi: 10.1097/JCN.0000000000000919. Epub 2022 Apr 27.
  PMID: 35482335
  citation: Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551.
  PMID: 35379503
  citation: McCraty R, Shaffer F. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk. Glob Adv Health Med. 2015 Jan;4(1):46-61. doi: 10.7453/gahmj.2014.073.
  PMID: 25694852
  citation: Vandenbogaart E, Gawlinski A, Grimley KA, Lewis MA, Pavlish C. App-Based Mindfulness Intervention to Improve Psychological Outcomes in Pretransplant Patients With Heart Failure. Crit Care Nurse. 2023 Apr 1;43(2):15-25. doi: 10.4037/ccn2023411.
  PMID: 37001879
  citation: Tabernero C, Gutierrez-Domingo T, Steca P, Castillo-Mayen R, Cuadrado E, Rubio SJ, Farhane-Medina NZ, Luque B. Effectiveness of Mindfulness and Positive Strengthening mHealth Interventions for the Promotion of Subjective Emotional Wellbeing and Management of Self-Efficacy for Chronic Cardiac Diseases. J Pers Med. 2022 Nov 25;12(12):1953. doi: 10.3390/jpm12121953.
  PMID: 36556174
  citation: MacEwen EG, Brown NO, Patnaik AK, Hayes AA, Passe S. Cyclic combination chemotherapy of canine lymphosarcoma. J Am Vet Med Assoc. 1981 Jun 1;178(11):1178-81. No abstract available.
  PMID: 6895078
  citation: Heo S, McSweeney J, Ounpraseuth S, Shaw-Devine A, Fier A, Moser DK. Testing a Holistic Meditation Intervention to Address Psychosocial Distress in Patients With Heart Failure: A Pilot Study. J Cardiovasc Nurs. 2018 Mar/Apr;33(2):126-134. doi: 10.1097/JCN.0000000000000435.
  PMID: 28661991
  citation: Curtis PJ. Globin mRNA in Friend cells: its structure, function and synthesis. Biochim Biophys Acta. 1980 Sep 22;605(3):347-64. doi: 10.1016/0304-419x(80)90016-5.
  PMID: 6996728
  citation: Simas W, Chiossi JC, Abib OA. [Urethral prolapse in a young woman]. Rev Paul Med. 1972 Aug;80(2):83-6. No abstract available. Portuguese.
  PMID: 4671576
  citation: Kang Q, Luo A. The efficacy of mindfulness-based intervention for heart diseases: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2022 Sep 30;101(39):e29649. doi: 10.1097/MD.0000000000029649.
  PMID: 36181030
  citation: Jalali D, Abdolazimi M, Alaei Z, Solati K. Effectiveness of mindfulness-based stress reduction program on quality of life in cardiovascular disease patients. Int J Cardiol Heart Vasc. 2019 Apr 12;23:100356. doi: 10.1016/j.ijcha.2019.100356. eCollection 2019 Jun.
  PMID: 31011624
  citation: Baumel A, Muench F, Edan S, Kane JM. Objective User Engagement With Mental Health Apps: Systematic Search and Panel-Based Usage Analysis. J Med Internet Res. 2019 Sep 25;21(9):e14567. doi: 10.2196/14567.
  PMID: 31573916
  citation: Felsted KF. Mindfulness, Stress, and Aging. Clin Geriatr Med. 2020 Nov;36(4):685-696. doi: 10.1016/j.cger.2020.06.010. Epub 2020 Aug 17.
  PMID: 33010903
  citation: Kabat-Zinn, J., & Hanh, T. N. (2009). Full catastrophe living: Using the wisdom of your body and mind to face stress, pain, and illness. Delta.
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: Undecided