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Development and Evaluation of Treatment Adherence Intervention for the Old Adults with Mild Cognitive Impairment based on the Internet of Things

Status Approved

  • First Submitted Date

    2020/12/14

  • Registered Date

    2020/12/31

  • Last Updated Date

    2020/12/14

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005728
    Unique Protocol ID 4-2019-1317
    Public/Brief Title Development and Evaluation of Treatment Adherence Intervention for the Old Adults with Mild Cognitive Impairment
    Scientific Title Development and Evaluation of Treatment Adherence Intervention for the Old Adults with Mild Cognitive Impairment based on the Internet of Things
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2019-1317
    Approval Date 2020-02-18
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Institutional Review Board Telephone 02-2228-0454
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Shin Jinhee
    Title PhD students
    Telephone +82-2-2228-3324
    Affiliation Yonsei University
    Address Yonsei University College of Nursing, 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Public Queries
    Name Shin Jinhee
    Title PhD students
    Telephone +82-2-2228-3324
    Affiliation Yonsei University
    Address Yonsei University College of Nursing, 50-1, Yonsei-ro, Seodaemun-gu, Seoul
    Contact Person for Updating Information
    Name Shin Jinhee
    Title PhD students
    Telephone +82-2-2228-3324
    Affiliation Yonsei University
    Address Yonsei University College of Nursing, 50-1, Yonsei-ro, Seodaemun-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-04-01 Actual
    Target Number of Participant 40
    Primary Completion Date 2020-11-30 , Actual
    Study Completion Date 2020-12-01 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-04-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Health Fellowship Foundation
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Background
    As the 4th industrial revolution, healthcare systems incorporating technology are emerging. The Internet of Things (IoT) market is rapidly growing, which provides off-line information to on-line (O2O), collects and analyzes data, and delivers information to smart devices or apps. Health care and prevention through the convergence of IoT and ICT to improve the quality of life as well as health life, changing the paradigm of prevention-centered medical service in treatment for the management of medical expenses and chronic diseases caused. These smart health devices are being used to help the memory of older adults with mild cognitive impairment. As a prior study of patients with mild cognitive impairment, a study on the medication adherence in chronic diseases, cognitive intervention program for improving cognitive function , exercise program, and complex intervention of exercise and cognitive function enhancement. For patients with mild cognitive impairment, maintenance of drug therapy for chronic diseases, constant exercise, and lifestyle changes are essential for the prevention, delay of dementia. There is a lack of comprehensive interventions to promote medication adherence and physical activity. With the advancement of technology due to the 4th industrial revolution, many devices have been developed that introduce IoT-based technology, it has the advantage of being able to intervention immediately by checking its current state. Therefore, this study aims to develop an IoT-based therapy compliance intervention based on a health belief model and determine the effectiveness to improve medication adherence and physical activity in the older adults with mild cognitive impairment.
    
    Purpose and hypothesis 
    The objective of this study was to develop a IoT based treatment adherence intervention for older adults with mild cognitive impairment and test the effects of the  program. The specific research hypotheses were as follows. 
    Hypothesis 1: The experimental group who participated in the intervention of treatment adherence based on the IoT for the older adults with mild cognitive impairment will improve in the experimental group in medication adherence (over time) than the control group.
    Hypothesis 2: The experimental group who participated in the intervention of treatment adherence based on the IoT for the older adults with mild cognitive impairment will improve in the experimental group in physical activities (over time) than the control group.
    Hypothesis 2-1: The experimental group who participated in the intervention of treatment adherence based on the IoT for the older adults with mild cognitive impairment will improve in the experimental group in physical activities score (over time) than the control group.
    
    Methods
    This study was randomized controlled trial and was conducted in a advanced general hospital in Seoul, Korea. Participants are older adults patients diagnosed with mild cognitive impairment by a neurologist. Thirty-eight participants in the neurology outpatient clinic of one hospital participated in this study. The subjects who participated in this study were 18 in the experimental group and 20 in the control group.IoT based smart pill box device measured medication adherence. 
    The experimental group was provided with a treatment adherence intervention program for 6 weeks and maintained for 4 weeks. The experimental group was provided with a treatment adherence intervention program for 6 weeks and maintained for 4 weeks. Only usual care was provided to the control group.The wearable device measured steps every day. Preliminary investigation, immediately after intervention (6 weeks), 4 weeks after intervention completion (10 weeks) was measured. STATA 16.0 version was used for data collection analysis. A mixed effects model and independent t-test were used in the analysis to evaluate the program over time.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    A 6-week intervention program was provided, followed by a 4-week maintenance period.
    IoT-based adherence treatment intervention was provided to the experimental group during the 6-week intervention period, an IoT-based smart pill box was installed at home, and a wearable device worn. In the introduction part, training was conducted using educational materials and handouts, demonstrations and practices , IoT smart pill boxes, and wearables device. 
    During the intervention period, an IoT-based smart pill box was used for reminders and personalized nursing coaching, and an alarm was given at the time of take a medication time, and weekly telephone consultation was conducted to evaluate and feedback. 
    The control group wore a wearables device and did not provide a intervention for 10 weeks.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    20

    Arm Type

    Experimental

    Arm Description

    Application of IoT-based treatment adherence intervention for 6 weeks
    -After installing a smart medicine box based on the Internet of Things at home, monitoring the patient's medication adherence with a monitoring server
    -Check the average number of steps per week after wearing a wearable device.
    -Implementation of education to promote health belief behavior
    -Weekly phone visit
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    20

    Arm Type

    No intervention

    Arm Description

    The control group wore a wearables device and did not provide a intervention for 10 weeks.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F06.7)Mild cognitive disorder 

    mild cognitive impairment
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~100Year

    Description

    Inclusion criteria
    ① Older adults aged 65 years or older and diagnosed with mild cognitive impairment by a neurologist
    ② No previous psychiatric diseases and no history of head injury
    ③ As a chronic disease, take one or more prescriptions for more than 3 months and take medication
    ④ No speech and hearing impairment, Independent walking is possible
    ⑤ Patients who volunteered for the study
    ⑥ Using a smartphone
    Exclusion Criteria
    Exclusion criteria
    ① Diagnosis of dementia
    ② Serious respiratory and cardiovascular disease
    ③ Disability that interferes with walking
    ④ Experience of participating in similar programs in the last 6 months
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Medication adherence rate
    Timepoint
    Pretest, 6weeks, 10weeks
    Secondary Outcome(s) 1
    Outcome
    Physical activity (Walk count, K-PASE)
    Timepoint
    Pretest, 6weeks, 10weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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