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
CRIS Registration Number |
KCT0005728 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Health Fellowship Foundation |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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 |
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Arm 2 |
Arm Label Control group |
Target Number of Participant 20 |
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Arm Type No intervention |
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Arm Description The control group wore a wearables device and did not provide a intervention for 10 weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F06.7)Mild cognitive disorder mild cognitive impairment |
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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 |
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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)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Medication adherence rate |
|
Timepoint | Pretest, 6weeks, 10weeks |
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Secondary Outcome(s) 1 | ||
Outcome | Physical activity (Walk count, K-PASE) |
|
Timepoint | Pretest, 6weeks, 10weeks |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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