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Verification of integrated service model for older patients using ICT

Status Approved

First Submitted Date

2019/09/04
Registered Date

2019/10/21
Last Updated Date

2023/03/02

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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	KCT0004360
Unique Protocol ID	B-1908/566-304
Public/Brief Title	Verification of integrated service model for older patients using ICT
Scientific Title	Verification of integrated service model for older patients using ICT
Acronym	Health RESPECT (integrated caRE Systems for elderly PatiEnts using iCT)
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	B-1908/556-304
Approval Date	2019-09-04
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
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	Kwang-il Kim
Title	MD.PhD
Telephone	+82-31-787-4052
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Jung-Yeon Choi
Title	MD, PhD
Telephone	+82-2-542-7110
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Jung-Yeon Choi
Title	MD, PhD
Telephone	+82-2-542-7110
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2019-09-05 Actual
Target Number of Participant	640
Primary Completion Date	2020-07-31 , Actual
Study Completion Date	2020-10-31 , Actual
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Completed
Date of First Enrollment	2019-09-05 ,

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	Korea Health Industry Development Institute
Organization Type	Government
Project ID	HI18C0037

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a randomized clinical trial that randomly assigns participating nursing homes or long-term care hospital to the intervention group and the control group. Are recruited as subjects. older adults who admitted at long-term care hospital or living in nursing home wererecruited from each institution. Medical staff from each institution are also recruited. Intervention groups are provided with ICT-assisted medical decision support and consultation model services, and control groups maintain routine care. Patients will be evaluated for clinical effectiveness, safety, quality of life and economic impact. Medical staffs will be assessed for process evaluation and willingness-to-pay. The datasets generated and/or analysed during the current study do not allow opening or sharing with any third party due to the policy of the SNBH IRB but are available from the corresponding author upon reasonable request

Study Summary Information

Lay Summary

This study is a randomized clinical trial that randomly assigns participating nursing homes or long-term care hospital to the intervention group and the control group. Are recruited as subjects. older adults who admitted at long-term care hospital or living in nursing home wererecruited from each institution. Medical staff from each institution are also recruited. Intervention groups are provided with ICT-assisted medical decision support and consultation model services, and control groups maintain routine care. 
Patients will be evaluated for clinical effectiveness, safety, quality of life and economic impact. Medical staffs will be assessed for process evaluation and willingness-to-pay.

The datasets generated and/or analysed during the current study do not allow opening or sharing with any third party due to the policy of the SNBH IRB but are available from the corresponding author upon reasonable request

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	Health Services Research
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others
Intervention Description	ICT-assisted medical decision support and consultation model services provided to the intervention group include (1) the comprehensive geriatric assessment (CGA) (2) establishment of individualized care plan considering the functional and disease status of each individual through the results of the CGA, (3) patient care service which include chronic disease management program (hypertension, diabetes, heart failure), rehabilitation program (dysphagia, physical, cognition) and inappropriate medication management service and (4) consultation and video conference service.
Number of Arms	2
Arm 1	Arm Label Intervention Group (Patients)
	Target Number of Participant 320
	Arm Type Experimental
	Arm Description ICT-assisted medical decision support and consultation model services provided to the intervention group include (1) the comprehensive geriatric assessment (CGA) (2) establishment of individualized care plan considering the functional and disease status of each individual through the results of the CGA, (3) patient care service which include chronic disease management program (hypertension, diabetes, heart failure), rehabilitation program (dysphagia, physical, cognition) and inappropriate medication management service and (4) consultation and video conference service.
Arm 2	Arm Label Controlled Group (Patients)
	Target Number of Participant 320
	Arm Type No intervention
	Arm Description The control group performs routine care without further intervention

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Quality of life Adverse Events Management in Nursing Homes or Long-term Care Hospital
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~No Limit
	Description Subject 1: Among the patients who are admitted to or living long-term care hospital or nursing home 1) age 65 and more 2) more than two weeks of hospitalization or living in the institution on the date of intervention or observation 3) who have One or more of the chronic diseases (hypertension, diabetes, heart failure, etc.) Subject 2: Medical staffs (physicians and nurses) who have worked or contracted with participating institutions and have participated directly in management of intervention or control group patients (Subject 1) : They are not included in the total number of subjects, but after the end of the study, the survey will be conducted on the level of satisfaction with the service use, process evaluation, and the willingness to pay
Exclusion Criteria	Subject 1 1) Patients who are expected to die or discharge within 3 months 2) Comatous status (can not do one-step obey command) 3) Subjects who do not agree with the study 4) significant reason for limiting the participation and progress of the research according to the judgment of the researcher other than the above mentioned criteria Subject 2 1) participants who are expected to change of work or termination of the contract during the study period 2) work experience in the instutition is less than one month
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Control rate of Hypertension
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Primary Outcome(s) 2
Outcome	Control rate of Diabetes
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Primary Outcome(s) 3
Outcome	Incidence rate due to heart failure
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Primary Outcome(s) 4
Outcome	Inappropriate Drug Prescription Rate
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Primary Outcome(s) 5
Outcome	Rate of polypharmacy
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Primary Outcome(s) 6
Outcome	Integrated function al status indicator level (InterRAI)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 1
Outcome	Incidence of Adverse Effects of Hypertension Treatment
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 2
Outcome	Hypoglycemia incidence
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 3
Outcome	Symptoms of Heart Failure (NYHA class)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 4
Outcome	Survival improvement drug for heart failure prescription rate
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 5
Outcome	Individual indicator of integrated function status (Individual Quality Indicators using interRAI LTCF)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 6
Outcome	Cognitive function score (MMSE)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 7
Outcome	Functional Ambulation Category [FAC] Score
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 8
Outcome	Pneumonia incidence due to aspiration
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 9
Outcome	Qualiy of life (EQ-5D)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 10
Outcome	Acute hospital use (hospitalization via emergency room, emergency room visit)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 11
Outcome	Clinical utility (Satisfaction with the experience)
Timepoint	Evaluate before or after the intervention or observation period (3 months)
Secondary Outcome(s) 12
Outcome	Economic effectiveness and efficiency
Timepoint	Evaluate before or after the intervention or observation period (3 months)

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	Yes Published
Final Enrollment Number	555
Number of Publication	2
Publications 1	JUNG-YEON CHOI, SEUNGYEON CHUN, HONGSOO KIM, YOUNG-IL JUNG, SOOYOUNG YOO, KWANG-IL KIM. Analysis of blood pressure and blood pressure variability pattern among older patients in long-term care hospitals: an observational study analysing the Health-RESPECT (integrated caRE Systems for elderly PatiEnts using iCT) dataset. Age and Ageing. SCI. 2022-03-01 , VOL : 51 page : 1 ~ 9 https://academic.oup.com/ageing/article/51/3/afac018/6540143?login=true
Publications 2	Jung-Yeon Choi Kwang-il Kim, Hongsoo Kim, Young-il Jung, In-Hwan Oh, Seungyeon Chun, Gi-Soo Kim, Jae-Young Lim, Jin Young Ko. Validation of an integrated service model, Health-RESPECT, for older patients in long-term care institution using information and communication technologies: protocol of a cluster randomised controlled trial. BMJ open. SCI. 2020-10-10 , VOL : 10 page : 1 ~ 8 https://bmjopen.bmj.com/content/10/10/e038598.long
Results Upload
Date of Posting Results	2023/02/22
Protocol URL or File Upload	(주) 2022 BMJ open COMPASS protocol paper (1).pdf
Brief Summary	In the intention-to-treat analysis, the diabetes control rate and discontinuation of PIM improved significantly in the intervention group. There was no significant difference between groups in cognitive and motor function, quality of life, and unplanned hospitalization.

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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