<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/NCT04470219</url>
  </required_header>
  <id_info>
    <org_study_id>RemindMe</org_study_id>
    <nct_id>NCT04470219</nct_id>
  </id_info>
  <brief_title>Digital Support for People With Cognitive Impairment</brief_title>
  <official_title>Digital Support for People With Cognitive Impairment - an Intervention to Increase Occupational Performance and the Possibility to Live a More Independent Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive impairment may cause problems in planning and initiating daily activities, as well&#xD;
      as remembering to do what is scheduled. This study investigates the effectiveness of an&#xD;
      interactive web-based mobile reminder calendar, (RemindMe). The calendar sends text messages&#xD;
      to the user's mobile phone as support in everyday life, for persons with cognitive impairment&#xD;
      due to neurological injury/diagnoses. The study has a randomized controlled trial design with&#xD;
      data collection at baseline and at follow-up sessions after two and four months. Data&#xD;
      collection started in October 2016 and continued until February 2018. RemindMe may give the&#xD;
      needed support to remind the person and thus increase the ability to perform activities and&#xD;
      to become independent in everyday life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.</time_frame>
    <description>The assessment is used to identify and measure performance and satisfaction with the performance of activities of daily living that are important to the person. Assessment is made on a scale from 1 to 10. 1 is the worst outcome and 10 is the best outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional independence measure (FIM)</measure>
    <time_frame>Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.</time_frame>
    <description>The assessment is used to identify and measure independence in everyday Life activities. Assessment is made on a scale from 1 to 7. 1 is the worst outcome and 7 is the best outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months</time_frame>
    <description>The assessment is used to assess Health-related Quality of Life (HQoL). Assessment is made on a Visual Analog Scale from 1 to 100. 1 is the worst outcome and 100 is the best outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Impact of Assistive Device Scale (PIADS)</measure>
    <time_frame>The psychosocial impact is assessed at baseline. Change from baseline in psychosocial impact is assessed after two months. And change from baseline after four months.</time_frame>
    <description>The assessment is used to assess an Assistive Device Psychosocial impact on a person. Assessment is made on a scale from -3 to 3. -3 is the worst outcome, 0 is neutral impact and 3 is the best outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Cognitive Impairments</condition>
  <condition>Stroke</condition>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive rehabilitation as usual and training how to use RemindMe by personnel from the research group and an occupational therapist working at the rehabilitation clinic. The participants will use RemindMe for two months. The participants choose activities that he/she wishes to remember to carry out with support by RemindMe. An individual follow-up session will be conducted once a week by the occupational therapist to evaluate if the chosen activities were performed and discuss strategies for the continued use of RemindMe. After two months the participants decide if he/she wants to continue to use RemindMe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group receive treatment as usual by the rehabilitation personnel, for example, occupational therapists give interventions that provide support for memory, it could be a paper calendar or other memory devices or strategies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive support by RemindMe</intervention_name>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with cognitive impairment after stroke or other neurological&#xD;
             diseases/injury&#xD;
&#xD;
          -  Participants experiencing the need for support in planning, organizing and remembering&#xD;
             to do activities in everyday life&#xD;
&#xD;
          -  Participants having access to a computer and mobile phone/smartphone&#xD;
&#xD;
          -  Participants having linguistic ability to participate in assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with palliative care needs&#xD;
&#xD;
          -  Participants with reduced vision and/or hearing loss that affects the ability to use a&#xD;
             mobile phone/smartphone&#xD;
&#xD;
          -  Participants with depression or psychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tiny Jaarsma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine and Health Sciences Linkoping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Region of Ostergotland</name>
      <address>
        <city>Linköping</city>
        <state>Ostergotland</state>
        <zip>581 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Tiny Jaarsma</investigator_full_name>
    <investigator_title>Professor at the Faculty of Medicine and Health Sciences</investigator_title>
  </responsible_party>
  <keyword>Self-Help Devices</keyword>
  <keyword>Occupational Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study result will be presented in Peer reviewed Open access journal</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04470219
org study id: RemindMe
nct id: NCT04470219
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cognitive impairment may cause problems in planning and initiating daily activities, as well
      as remembering to do what is scheduled. This study investigates the effectiveness of an
      interactive web-based mobile reminder calendar, (RemindMe). The calendar sends text messages
      to the user's mobile phone as support in everyday life, for persons with cognitive impairment
      due to neurological injury/diagnoses. The study has a randomized controlled trial design with
      data collection at baseline and at follow-up sessions after two and four months. Data
      collection started in October 2016 and continued until February 2018. RemindMe may give the
      needed support to remind the person and thus increase the ability to perform activities and
      to become independent in everyday life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Canadian Occupational Performance Measure (COPM)
time frame: Occupational performance is assessed at baseline. Change from baseline in occupational performance is assessed after two months. And change from baseline after four months.
description: The assessment is used to identify and measure performance and satisfaction with the performance of activities of daily living that are important to the person. Assessment is made on a scale from 1 to 10. 1 is the worst outcome and 10 is the best outcome.
measure: Functional independence measure (FIM)
time frame: Independence is assessed at baseline. Change from baseline in independence is assessed after two months. And change from baseline after four months.
description: The assessment is used to identify and measure independence in everyday Life activities. Assessment is made on a scale from 1 to 7. 1 is the worst outcome and 7 is the best outcome.
measure: EQ-5D-5L
time frame: HQoL is assessed at baseline. Change from baseline in HQoL is assessed after two months. And change from baseline after four months
description: The assessment is used to assess Health-related Quality of Life (HQoL). Assessment is made on a Visual Analog Scale from 1 to 100. 1 is the worst outcome and 100 is the best outcome.
measure: Psychosocial Impact of Assistive Device Scale (PIADS)
time frame: The psychosocial impact is assessed at baseline. Change from baseline in psychosocial impact is assessed after two months. And change from baseline after four months.
description: The assessment is used to assess an Assistive Device Psychosocial impact on a person. Assessment is made on a scale from -3 to 3. -3 is the worst outcome, 0 is neutral impact and 3 is the best outcome.
arm group label: intervention group
arm group type: Experimental
description: Participants receive rehabilitation as usual and training how to use RemindMe by personnel from the research group and an occupational therapist working at the rehabilitation clinic. The participants will use RemindMe for two months. The participants choose activities that he/she wishes to remember to carry out with support by RemindMe. An individual follow-up session will be conducted once a week by the occupational therapist to evaluate if the chosen activities were performed and discuss strategies for the continued use of RemindMe. After two months the participants decide if he/she wants to continue to use RemindMe.
arm group label: control group
arm group type: No Intervention
description: The control group receive treatment as usual by the rehabilitation personnel, for example, occupational therapists give interventions that provide support for memory, it could be a paper calendar or other memory devices or strategies.
intervention type: Other
intervention name: Cognitive support by RemindMe
arm group label: intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Tiny Jaarsma
role: Principal Investigator
affiliation: Faculty of Medicine and Health Sciences Linkoping University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Tiny Jaarsma
investigator title: Professor at the Faculty of Medicine and Health Sciences
mesh term: Brain Injuries
mesh term: Cognitive Dysfunction
sharing ipd: Yes
ipd description: Study result will be presented in Peer reviewed Open access journal